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Using the Clinical Research Network for psychosocial cancer research: lessons learned from two observational studies Penny Wright,1 Deborah Fenlon,2 Helen Jones,1 Claire Foster,2 Laura Ashley,3 Kim Chivers Seymour,2 Galina Velikova,1 Ikumi Okamoto,2 Julia Brown4
1
Psychosocial Oncology and Clinical Practice Research Group, Leeds Institute for Cancer and Pathology, University of Leeds, Leeds, West Yorkshire, UK 2 Macmillan Survivorship Research Group, Faculty of Health Sciences, University of Southampton, Southampton, UK 3 School of Social, Psychological & Communication Sciences, Faculty of Health and Social Sciences, Leeds Metropolitan University, Leeds, UK 4 Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK Correspondence to Dr Penny Wright, Psychosocial Oncology and Clinical Practice Research Group, Level three Bexley Wing, St James’s Institute of Oncology, St James’s University Hospital, Leeds, West Yorkshire LS9 7TF, UK; [email protected] Received 8 November 2012 Revised 11 June 2013 Accepted 24 July 2013 Published Online First 19 August 2013
To cite: Wright P, Fenlon D, Jones H, et al. BMJ Supportive & Palliative Care 2014;4: 202–211.
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ABSTRACT Background Patient recruitment to psychosocial oncology research has increased but the many studies have been single-site or small-scale. The National Institute for Health Research Clinical Research Network, supports National Institute for Health Research portfolio studies through provision of research staff for recruitment and follow-up. These studies are usually clinical trials of an investigational medicinal product. Psychosocial researchers have little used this resource. Process We report the processes followed and experiences of two psychosocial research teams who recently used the Clinical Research Network, to undertake patient recruitment to two prospective observational studies: electronic Patient-reported Outcomes from Cancer Survivors study (ePOCS) and the ColoREctal Wellbeing study (CREW). Both research groups employed different approaches to using Clinical Research Network support. Outcomes ePOCS secured Comprehensive Local Research Networks funding to appoint ePOCSspecific study research nurses. CREW obtained research support through the National Institute for Health Research Cancer Research Network. Recruitment targets were met (ePOCS n=636; CREW n=1055) despite logistical, administrative and bureaucratic challenges in setting up the studies. Research nurses feedback was mainly positive (ePOCS study only). Top tips for establishing and running psychosocial studies with Clinical Research Network staff are provided and suggestions given for advancing multicentre complex psychosocial studies. Conclusions Some challenges were similar to those in delivery of clinical trials of an investigational medicinal product. The pros and cons of being involved in ePOCS from the
research nurse perspective are also described. Overall the approaches used were successful with both studies reaching their recruitment targets.
INTRODUCTION The importance of psychosocial oncology has been increasingly recognised over recent decades, leading to the Union International for Cancer Control declaring ‘distress’ the 6th vital sign in Cancer Care.1 Despite this, psychosocial care has not become fully integrated into routine cancer care. A number of challenges persist including how psychosocial oncology is valued as a discipline in its own right, the costs of supportive care, and a lack of evidence from large-scale well-designed psychosocial trials.2 In the UK cancer research has been nurtured by the establishment of the National Cancer Research Institute (http://www.ncri.org.uk/) Clinical Studies Groups. Clinical Studies Groups facilitate and prioritise studies to address cancer diagnostic-specific questions (ie, breast, lung) or cross-cutting issues (ie, palliative, psychosocial). The National Institute of Health Research (NIHR) Cancer Research Network (http://www.ncrn.org.uk/), established in parallel with the National Cancer Research Institute, was set up to increase the number of patients participating in high-quality clinical research studies. The NIHR Cancer Research Network comprises 32 Local Research Networks across England and provides an infrastructure to support study participation, including funding for research nurses. Since 2006 their main focus has been on recruitment to clinical trials of an investigational medicinal product randomised controlled trials.
Wright P, et al. BMJ Supportive & Palliative Care 2014;4:202–211. doi:10.1136/bmjspcare-2012-000410
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Features This has led to increased accrual to randomised controlled trials but not at the expense of accrual to observational studies, maybe because some observational studies provide an opportunity for patients to enrol in randomised controlled trials at the same time.3 Timely accrual to randomised controlled trials and observational studies within the cancer trials portfolio has increased significantly since the NIHR Cancer Research Network was established, rising from 20% in 2010.3 Although the majority of trials within the portfolio are clinical trials of an investigational medicinal product there is interest in developing other types of interventional studies.4 The success of the NIHR Cancer Research Network model for supporting clinical trials in England led to the establishment of a generic Clinical Research Network to provide infrastructure for other clinical groups. The elements of the NIHR Clinical Research Network and their inter-relationships and acronyms can be confusing. Figure 1 provides an overview and places the national and local level of networks into context. The NIHR Cancer Research Network-National Cancer Research Institute Clinical Studies Group model for developing and delivering high-quality large-scale trials has worked well for clinical trial evaluation of investigational medicinal products. Some of these trials have either secondary quality of life outcomes as part of the main study or have linked substudies with primary quality of life outcomes which have been very informative. In the disease site-specific Clinical Studies Groups the majority of members are clinicians. The trials become embedded within clinical practice across a number of centres where patients are considered for participation at multidisciplinary team meetings by clinicians and associated research nurses. Across the country there is a network of clinicians who have duty of care for these patients, who are research active and who contribute to accrual of portfolio clinical trials of an investigational medicinal product with support mainly from the NIHR Cancer Research Network. However, this approach is not suitable for many studies where the primary research question addresses psychosocial issues or complex interventions in more depth and in a wide population. The Psychosocial Oncology Clinical Studies Group comprises a varied membership (including health psychology, social work, nursing, clinical trials), few of whom have responsibility for clinical care. The range of studies within the psychosocial oncology portfolio is broad, including studies of interventions from acupuncture to cognitive-behavioural therapy, studies to develop patient decision aids, and observational studies of patients’ quality of life, health behaviours and care experience. There is no readymade clinical infrastructure or experienced study recruitment network to call on for championing multicentre psychosocial studies. In addition, psychosocial studies may require specialist professional input, which is not part of the standard clinical research team, to deliver an intervention or undertake
specialised interviewing or observations. As a result although there have been some high-quality large-scale psychosocial studies,5–7 many studies within the growing Psychosocial Oncology Clinical Studies Group portfolio have been single-site or small-scale and have tended to rely on individual grant-funded appointed research assistants, rather than using network research nurses, for recruitment and follow-up of patients. Now there is an expectation that some research costs will no longer be met by some grant awarding bodies. The recently published Department of Health AcoRD document provides the basis for attributing the costs of health and social care research studies in three categories: research costs (costs of activities undertaken to answer the research questions), National Health Service (NHS) treatment costs (costs of patient care) and NHS support costs (additional patient care costs associated with the research).8 If a study is funded by a charity which is a member of the Association of Medical Research Charities some NHS support costs will be met by the Department of Health, via the networks, such as the identification of patients suitable to approach for participation, obtaining consent and additional assessments. In order for the Psychosocial Oncology Clinical Studies Group to consistently deliver high-quality large-scale observational studies and trials, use of the networks for recruitment support will have to become standard practice. In 2010–2012 two Psychosocial Oncology Clinical Studies Group portfolio observational cohort studies, funded by Macmillan Cancer Support (Association of Medical Research Charities member) and run by University sponsored researchers, collaborated in two different ways with the networks to support recruitment. In the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) study the research team applied for study-specific funding for research nurses to the generic West Yorkshire Comprehensive Local Research Network; in the ColoREctal Wellbeing (CREW) study the research team asked for expressions of interest for study participation from the NIHR Cancer Research Networks (figure 1). Both studies were given research ethics committee approval (ePOCS (Leeds East 10/H1306/65); CREW (Oxfordshire REC B 10/H0605/31)) and all participants provided written informed consent. We report and compare the different approaches of ePOCS and CREW with the aim of informing researchers of clinical trials which are not an investigational medicinal product of lessons learned and providing recommendations for future studies. THE STUDIES Electronic Patient-reported Outcomes from Cancer Survivors http://public.ukcrn.org.uk/Search/StudyDetail. aspx?StudyID=9403
ePOCS is a secure electronic system for collecting Patient Reported Outcome Measures via the internet at multiple time points and linking these data with
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Figure 1
Overview of the NIHR Clinical Research Network (England) with an emphasis on the Yorkshire Cancer Research Network.
patients’ clinical data transferred from the electronic patient record to the cancer registry and managing associated patient communications electronically.9 The ePOCS study is a prospective observational study to test the feasibility of the ePOCS system, by running it for 2 years in two NHS Trusts within the Yorkshire Cancer Network (the cancer centre and one cancer unit), and using the Northern and Yorkshire Cancer Registry and Information Service.10 To test feasibility, all patients with non-metastatic breast, colorectal and prostate cancer attending the two Yorkshire Cancer Network Trusts within 6 months post diagnosis needed to be considered for recruitment (estimated 204
target n=600). Funding was obtained from the West Yorkshire Comprehensive Local Research Network to appoint research nurses to be embedded within established cancer site-specific clinical research teams to recruit expressly to ePOCS over 1 year. Participants were followed up by the University of Leeds ePOCS research team comprising a Research Lead, Research Fellow and Senior Research Nurse. ColoREctal Wellbeing http://public.ukcrn.org.uk/Search/ StudyDetail.aspx?StudyID=9374
The CREW study is a prospective observational study involving patients with colorectal cancer following
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Features primary surgery using mailed questionnaires. The aim of the study is to establish the natural history of the recovery of health and well-being following treatment for colorectal cancer.11 The CREW team at the University of Southampton included the Research Programme lead, Senior Research Fellow, Research Fellow, Trial Coordinator and Administrator. They worked with cancer centres across wide geographic and sociodemographic areas which could identify, approach and recruit all study-eligible patients to ensure best representation. To recruit a large number of patients (target n=1000) in 1 year the NIHR Cancer Research Network was approached to support study recruitment as part of their local portfolio of studies. Sites were selected on their ability to recruit in a specified way and to recruit at least 2–3 participants weekly. The research nurses recruiting to CREW were established members of clinical research teams, with shared responsibility for recruitment to CREW and to other clinical trials of investigational medicinal products. Both studies
The research nurses recruiting to these studies operated in much the same way as for clinical trials of an investigational medicinal product in terms of collaborating and negotiating with multidisciplinary teams to identify and approach eligible patients. The research nurses informed and consented eligible patients, provided participants with written study information, completed and returned study documentation to the ePOCS or CREW research teams and, for the ePOCS study, entered study events onto a clinical trials database within the electronic patient record.12 Unlike many traditional cancer clinical trials, the research nurses consented and countersigned the consent forms and, for CREW, in some centres were Principal Investigators. Research nurses were not involved with participants after the point of study-consent. Records were kept of the steps undertaken to encourage support for both studies, and of the outcomes of these. In ePOCS, following recruitment completion, the research nurses were interviewed by the ePOCS senior research nurse to find out what it was like to work on ePOCS, how it compared with recruiting to traditional clinical trials, and suggestions as to how the research nurse role might have been improved. Interviews were audio-recorded and opinions collated. ePOCS and Crew study outcomes are being reported in full elsewhere. PROCESSES AND OUTCOMES How the studies were established within centres and networks ePOCS
As ePOCS was a University of Leeds sponsored study the first task was to find managers in each NHS trust to work with the ePOCS research team to make the application for West Yorkshire Comprehensive Local
Research Network funding. Approved funding had to be transacted through a NHS Trust and held by a Trust budget holder. Initially, an application for responsive funding to the West Yorkshire Comprehensive Local Research Network was made on behalf of ePOCS by the Directorate Manager of non-surgical oncology in the Cancer Centre for three Yorkshire Cancer Network whole time equivalent research nurses for 1 year. Later, additional funding was approved by the West Yorkshire Comprehensive Local Research Network for one further whole time equivalent research nurse for 1 year at the cancer unit. There were delays in appointing the research nurses (three full-time posts; two part-time posts), with start dates staggered over 4 months (figure 2A). Reasons included protracted negotiations with the cancer centre Trust to find the staff to manage the budget, a lack of understanding by the ePOCS research team about NHS human resources and financial systems, disjointed communication with human resources concerning the research nurse appointment process and being caught by a 4-month Trust recruitment freeze. In the cancer unit the delay in research nurse appointment was due to the later application for funding. In addition, four of the five appointed research nurses were new to the role, two to the trusts and three to the tumour groups they were recruiting, thus requiring time for induction. The delays and staggered starts meant the recruitment period became asynchronous with the grant period and it was necessary to negotiate a no-cost extension with the funder. CREW
CREW put out a call to the Cancer Research Networks from the NIHR Cancer Research Network Coordinating Centre to complete an ‘Expression of Interest’ form. Sites were selected according to a number of factors including: speed to achieve Research and Development (R&D) approval, ability to recruit good numbers, attendance at a site investigator meeting and demonstration of close working between the clinical and research teams. It was originally planned to recruit from 24 sites, however, not all sites were able to commence recruitment as expected or at the anticipated rate. Therefore the number of participating sites was increased to 30 including further sites being sought from the devolved nations. Thirteen English, two Scottish and two Welsh cancer networks were involved. Methods employed to support the recruiting centres and research nurses ePOCS Set-up
Clinicians were consulted in the development phase of ePOCS.13 A detailed recruitment process map was iteratively created, and checked with the clinical teams. As the research nurses had staggered starts, their training was largely individual and undertaken
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Figure 2
(A) Electronic Patient reported Outcomes from Cancer Survivors (ePOCS) and (B) ColoREctal Wellbeing (CREW) recruitment.
by the ePOCS senior research nurse. In the month before recruitment started, a half-day site investigator meeting was held at the cancer unit (seven attendees). In addition to the protocol, a comprehensive study guide and copies of the recruitment maps were provided for the research nurses. Ongoing support
Ongoing support to the research nurses by the ePOCS senior research nurse (and research fellow in her absence) was provided by telephone, email and weekly 206
visits. Progress review meetings were held at 3 months (11 attendees) and 7 months (4 attendees) into recruitment. A log was kept of study related queries between the ePOCS team and research nurses. The number of research nurse queries was highest at the start of recruitment and fell as the nurses became familiar with study procedures (figure 2A). Eighty-four queries were raised in total, via phone (n=35), email (n=25) or face-to-face (n=23) (one unspecified). Queries concerned eligibility criteria, completion of study events on the electronic patient record, logistical and
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Features administrative tasks and verification of patient email addresses. The ePOCS team sent emails to the clinical teams (and research nurses) following recruitment of every 50th patient, and a congratulatory email on study close. The ePOCS website (http://www.epocs.leeds.ac. uk/) was updated about once a month with study news including recruitment figures and information about academic presentations and publications. CREW Set-up
Sites that joined CREW were sent instructions for recruitment and underwent a telephone conference for study set-up. An initial CREW site investigator meeting was held in the University of Southampton immediately prior to recruitment commencement to inform those who would be involved in CREW recruitment about the study and for them to consider how to ensure they were able to approach every eligible patient in their centre (29 attendees). Ongoing support
All study sites were contacted at least weekly detailing data returns from each site and what was outstanding. A further site investigator meeting was set up after 8 months to update the recruitment staff, and for those who had not had an opportunity to attend the first meeting (21 attendees). There was a final meeting following recruitment closure in order to celebrate reaching the accrual target (24 attendees).The CREW administrative staff had frequent email and telephone contact with all sites. Technical queries were passed onto the study principal investigator or clinical co-investigators. Patient recruitment ePOCS
Despite having planned for a year to setup ePOCS, including time to apply for West Yorkshire Table 1
Comprehensive Local Research Network funding and appointing research nurses, the start date was slightly delayed due to the reasons outlined above, and recruitment took time to become established in all possible clinics. It was anticipated there would be cross-cover within the clinical research teams, such that the ePOCS research nurses would contribute to recruiting to other studies, and other research nurses would help support ePOCS. In reality, there was limited cross-cover undertaken for ePOCS by non-ePOCS research nurses. Active recruitment lasted just over 10 months, 2 months longer than planned, with 636 participants consenting (figure 2A). CREW
In order to ensure research nurses undertook recruitment according to the CREW protocol, the CREW researchers asked the teams to consider their recruitment processes and to write these into their ‘Expression of Interest’ to participate in the study. This was also rehearsed at the site investigator meetings. As R&D approval was protracted in some areas and there were fewer than anticipated eligible patients in some clinics (as estimated by the sites in their expression of interest), the overall recruitment rate was slower than expected. Recruitment lasted 17 months, 5 months longer than planned, with 1055 participants consenting from 29 sites across 17 cancer networks (including 66 participants from a pilot study) (figure 2B). Nurse feedback (ePOCS study only)
The three full-time and one of the two part-time ePOCS research nurses were interviewed at the end of the study. In general the nurses gave positive feedback about their involvement in the ePOCS study, although some downsides were identified (table 1). Four out of the five ePOCS research nurses have continued to
electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) research nurse feedback: top 10 Pros and Cons
Pros
Cons
1. 2.
1.
The research nurses found ePOCS an interesting study. ePOCS research nurses were the experts in the study at multidisciplinary team meeting. 3. Broad eligibility criteria meant large numbers of patients could be approached and recruited. 4. Recruitment criteria allowed a varied time of approach postdiagnosis. 5. ePOCS required no additional hospital visits. 6. Research nurses found ePOCS easier to explain to patients than clinical trials of investigational medicinal products. 7. The ePOCS study was easy for patients to understand. 8. Patients were interested in ePOCS 9. It was easy for patients to make a decision about joining ePOCS. 10. Immediate patient consent was allowed.
The ePOCS research nurses had to put in a lot of effort to get doctors on board. 2. As there was a broad eligibility criteria and there were many clinics to cover. 3. The ePOCS study was not a high priority in clinics. 4. Usually doctors needed reminding to mention to patients about the ePOCS study. 5. Cover for ePOCS research nurse absence was a problem. 6. ePOCS research nurses found it hard to support other portfolio studies as their time was taken up with ePOCS. 7. Obtaining patient notes to file ePOCS consent forms was an issue. 8. No follow-up with patients was a downside. 9. Being involved in ePOCS only could become dissatisfying over time. 10. As with other studies, ePOCS research nurses felt under pressure to recruit which was not so good when recruitment is not going well.
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Features work as research nurses, with one moving into the academic psychosocial research team and the others staying in clinical research teams. Top Tips from lessons learned
Box 1 summarises the top tips learned from these experiences, which would also apply to clinical trials of investigational medicinal products. DISCUSSION Using network resources to underpin recruitment to two prospective observational psychosocial studies was successful with both studies reaching their recruitment targets. Study set-up
The process of engaging the research networks and NHS trusts in these recruitment initiatives was, on occasion, complicated, time-consuming and frustrating for all concerned, but with perseverance and goodwill from individual champions positive outcomes were achieved. Using traditional psychosocial recruitment methods, with grant funded research assistants creates a number of challenges. (1) Financial: the costs of employing research assistants would have been prohibitive for a national multicentre study. (2) Bureaucratic:
the time and negotiations required to enable multiple employers to recruit, induct and line manage research assistants would have been unfeasible. (3) Promotional: the establishment of a psychosocial study, not linked with an existing randomised clinical trial of an investigational medicinal product, led by a research assistant not linked with a clinical team, would have been be extremely difficult. The feedback from the ePOCS research nurses was on the whole positive. The lessons learned from ePOCS and CREW should help non-clinically based academic researchers wishing to undertake psychosocial research in the NHS.
Recruitment challenges
Common to many studies, recruitment took a while to become established and gain momentum. For the ePOCS study this related mainly to the ePOCS team not being experienced in navigating NHS human resources systems, NHS processes slowing research nurse appointments and, as this was a new scenario for the research nurses, a ‘learning’ period was required. As psychosocial researchers become more experienced and familiar with NHS systems, and build relationships with NHS colleagues, some of these challenges will be overcome in future collaborations. Having adequate support from relevant local
Box 1 Top tips for using the Clinical Research Network to support patient recruitment to psychosocial cancer research 1. 2. 3. 4. 5.
6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
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Allow more time than you expect for study set-up. Find local NHS and network champions (clinical and management) with whom to collaborate. For a multicentre study consider the challenges of ensuring your study is included into the local portfolio of a network and appropriately supported by clinical research network staff. If conducting a multicentre study liaise with the national coordinating centre to discuss feasibility and deliverability to develop achievable milestones. For limited site studies consider whether it would be more efficient to seek dedicated clinical research staff (either from existing establishments or through applying for time-limited funding through National Institute of Health Research Comprehensive Local Research Networks). Work closely with local R&D managers and invite them to site investigator meetings where possible. Give as much information as possible in advance so that local teams can make realistic assessments of what is achievable, especially for UK-wide trials. Provide clear and comprehensive resources for the research nurses for their own use, and for them to educate clinical and multidisciplinary team colleagues. Be flexible to accommodate local variation; one size does not fit all. Work with local research nurses and clinical teams to establish best recruitment methods for specific clinical practices. Invest time in training research nurses to undertake recruitment, especially if they are new to post. Respond quickly to research nurse queries and ensure you have senior research team members available to answer complex questions. Create good relationships with clinical staff by developing open communication using a variety of methods (email, fax, face-to-face meetings, phone, website). Regularly provide feedback on local and overall recruitment to networks, clinical teams and research nurses. Arrange study events/workshops for recruiting teams. Celebrate success. Keep the funder up to date with progress and challenges. Thank all involved and acknowledge them in presentations and publications.
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Features organisations (R&D, Comprehensive Local Research Network, trusts and clinical teams) is key for good representative recruitment. Although in principle these organisations support all portfolio-adopted studies, non-clinical studies may be seen as less important than clinical studies. This can lead to a recruitment bias where psychosocial studies may only have access to patients not involved in clinical trials. In the ePOCS study this was not a problem as it was accepted by all parties that patients could be approached about ePOCS even if they were involved in clinical trials. This was more difficult for the CREW study where in some sites recruitment was squeezed due to competing trials. To eliminate this problem, where possible, the CREW team chose sites without competing studies. Uptake of psychosocial studies may be further challenged when the chief and principal investigators are not embedded in clinical services and are not therefore party to the traditional medical model of clinical colleagues supporting each other’s studies. Again, similar to many clinical trials of an investigational medicinal product, one main delay in recruitment to the CREW study was obtaining R&D approvals. Although research governance application and approval processes have improved over the last 10 years, problems with R&D approvals continue to cause delays in many studies.14 15 Despite these initial challenges, accrual targets were met; an important contributory factor may have been the careful attention to planning and trial management as advocated in one multicentre ovarian cancer screening trial.16 The role of the research nurse and others in the research team
The research nurses who undertook recruitment were part of established clinical research teams whose main research activities related to cancer clinical trials, as described by the UK Clinical Research Collaboration.17 The classical role of the research nurse has been defined as covering five main activities: clinical practice, care coordination and continuity, study management, human subject protection and contributing to science, with the most important of these reported by research nurses as being clinical practice and care coordination and continuity.18 In ePOCS and CREW, clinical practice and care coordination and continuity were not part of the research nurse role. In the long term, if research nurses were restricted to involvement with simple consenting for non-interventional studies only, job satisfaction may be compromised, as highlighted in the ePOCS research nurse feedback. The CREW approach may provide a more sustainable model, by providing research nurses with a mixed workload and delivering high recruitment figures which reflect well on the clinical teams and networks. This may have wider benefits by raising awareness of psychosocial studies at multidisciplinary team/clinic
level within a portfolio of classic medical interventions. The CREW approach has been effective in the highest recruiting psychosocial portfolio study to date: the multinational Computerised Adaptive Testing for EORTC-QLQ-C30 (CAT) study (UKCRN ID 5256). Between April 2010 and March 2011 NIHR Cancer Research Network research nurses recruited 1603 participants to CAT across the UK ( personal communication K Poole, 2012). CAT has wide eligibility criteria and requires a single administration of one questionnaire ( personal communication T Young, 2012). CAT, CREW and ePOCS are all simple observational studies where no new skills were required for the research nurses. The ePOCS, CREW and CAT studies described earlier, accounted for 57% of participants recruited to the Psychosocial Oncology Clinical Studies Group portfolio between April 2011 and March 2012. It may be a much more difficult task if there is a need to train research nurses in new skills (eg, for psychosocial intervention studies). Other recruitment models have also been shown to be successful. In the Northern Cancer Research Network, Clinical Trial Officer roles have been developed resulting in increased recruitment to network adopted studies.19 In Southampton, the Macmillan research team has appointed a Macmillan-funded trials coordinator to support their portfolio studies by working within the research team to raise awareness of the processes and clinical realities impacting on non-clinical research. Funding and employment issues
Other challenges to psychosocial research may arise as NIHR/Government funders adhere strictly to AcoRD documents and insist on classifying many of the psychosocial researchers’ tasks as NHS support costs (to be paid for by Comprehensive Local Research Network and done by research nurses in general). As demonstrated in ePOCS, there is considerable administrative burden in study set-up and appointing, training and supporting research nurses. The appointment of research staff (financially supported by the funders) is even more important for these studies and possibly requires more senior researchers with longer contracts. The balance between research and NHS support staff is different for psychosocial studies and should be recognised by researchers and funders. In Leeds, following closure of ePOCS, other West Yorkshire Comprehensive Local Research Network funded research nurses have been appointed to work within the university psychosocial oncology research group rather than within clinical research teams. This approach may be particularly useful for more complex randomised intervention studies which may involve patient tracking, interviewing, delivering interventions and/or audio-recording consultations. Nurses will bring experience and knowledge of communicating with patients and carers, and of the patient experience
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Features and treatment pathways, as well as familiarity with medical terminology and the clinical environment. The psychosocial oncology research team can provide research training and ongoing support and supervision to research nurses appointed in this way. This may help to promote research nurses’ knowledge of research and thus in some cases nurture their transition from research nurses to individuals pursuing their own research career.17 The disadvantage of this approach is the partial separation from clinical teams and resultant research governance issues concerning screening and recruiting patients for trial participation which may require application to the Care Quality Commission National Information Governance Committee (formally National Information and Governance Board for Health and Social Care). It also generates problems with running multicentre psychosocial studies if the research nurses are trained and based for more complex psychosocial studies in one centre only. In addition there may be repercussions for staff. Research nurses who have taken on more complex leadership roles in non-traditional clinical trials have reported challenges with isolation, role conflict, limited cooperation from clinical staff and difficulties maintaining motivation.20 Collaborative networking
Using the networks to support more complex multicentred psychosocial oncology intervention trials will require considerable effort and new ways of working. One way of taking this forward may be to encourage networks active in psychosocial oncology recruitment to identify a staff member to act as a network expert with the remit to encourage development and support of the psychosocial portfolio and liaise with the National Cancer Research Institute Psychosocial Oncology Clinical Studies Group. There are 10 networks which have participated in five or more psychosocial studies ( personal communication K Poole, 2012). Another way will be for members of the Psychosocial Oncology Clinical Studies Group to learn from ours and others’ experiences, work more collaboratively across the Psychosocial Oncology Clinical Studies Group, with site-specific Clinical Studies Groups and with clinical partners, harness the resources of the networks and gradually build expertise across selected networks. By using these approaches psychosocial oncology research in the UK may increase the numbers of large complex multicentre intervention studies. Limitations
In the ePOCS study feedback interviews were undertaken with the research nurses, not possible for the CREW study. Although many of the issues raised are likely to be similar for CREW and ePOCS research nurses there is no way of confirming this. In addition it would have been interesting to have sought opinion 210
from the wider research team members involved in study recruitment to assess the impact of CREW and ePOCS on other clinical research (value for money, time invested and recruitment numbers across all studies). Again this was out with the remit of each study. CONCLUSION The ePOCS and CREW studies have demonstrated that hard work and collaborative working to harness network resources to support psychosocial studies does result in positive outcomes. Many challenges experienced were similar to those found in traditional clinical trials. To achieve parity with clinical trials of investigational medicinal products in front-line clinical research, psychosocial researchers will have to continue investing time and effort to promote the importance and value of psychosocial research to clinical colleagues, train network-research nurses to undertake more complex tasks and deliver well-designed clinical trials with demonstrable patient benefits. Acknowledgements We thank all the patients, staff and the research nurses who supported these studies. We are grateful to Karen Poole and Teresa Young, Mount Vernon Cancer Centre, UK for providing us with personal communications and to Karen Poole, National Institute for Health Research Cancer Research Network, and Eileen Loucaides, National Cancer Research Institute Clinical Studies Groups Secretariat, for their feedback on this article. Contributors Conceived the studies: PW, GV, JB, CF and DF. Designed the studies: PW, GV, JB, LA, HJ, CF and DF. Enrolling participants: LA, HJ, KCS and IO. Data collection, collation and cleaning: LA, HJ, KCS and IO. Data analysis: PW, LA, HJ, KCS and DF. Drafted the paper: PW. Critical revision of the article and approval of the final article: PW, GV, JB, LA, HJ, CF, DF, KCS and IO. Guarantors of the work: PW and CF. Funding This research was funded by Macmillan Cancer Support. Competing interests None. Ethics approval National Research Ethics Service Committee South Central Oxford B (ref. 10/H1306/65), and the University Hospital Southampton NHS Foundation Trust Research and Development Department R&D ref number: RHM CAN0737. Leeds (East) research Ethics Committee10/H1306/65. Provenance and peer review Not commissioned; externally peer reviewed.
REFERENCES 1 Holland J, Watson M, Dunn J. The IPOS New International Standard of Quality Cancer Care: integrating the psychosocial domain into routine care. Psychooncology 2011;20:677–80. 2 Bultz BD, Johansen C. Screening for Distress, the 6th Vital Sign: where are we, and where are we going? Psychooncology 2011;20:569–71. 3 Cameron D, Stead M, Lester N, et al. Research-intensive cancer care in the NHS in the UK. Ann Oncol 2011;22:29–35. 4 Stead M, Cameron D, Lester N, et al. Strengthening clinical cancer research in the United Kingdom. Br J Cancer 2011;104:1529–34. 5 Fallowfield L, Jenkins V, Farewell V, et al. Efficacy of a Cancer Research UK communication skills training model for oncologists: a randomised controlled trial. Lancet 2002;359:650–6.
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Features 6 Velikova G, Booth L, Smith AB, et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 2004;22:714–24. 7 Armes J, Crowe M, Colbourne L, et al. Patients’ supportive care needs beyond the end of cancer treatment: a prospective, longitudinal survey. J Clin Oncol 2009;27:6172–9. 8 Department of Health Research and Development Directorate. Attributing the costs of health and social care Research & Development (AcoRD). Department of Health. London: Crown, 2012. 9 Ashley L, Jones H, Thomas J, et al. Integrating cancer survivors’ experiences into UK cancer registries: design and development of the ePOCS system (electronic Patient-reported Outcomes from Cancer Survivors). Br J Cancer 2011;105(S1): S74–81. 10 Ashley L, Jones H, Forman D, et al. Feasibility test of a UK-scalable electronic system for regular collection of patient-reported outcome measures and linkage with clinical cancer registry data: The electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system. BMC Med Inform Decis Mak 2011;11:66. 11 Fenlon D, Richardson A, Addington-Hall J, et al. A cohort study of the recovery of health and wellbeing following colorectal cancer (CREW study): protocol paper. BMC Health Serv Res 2012;12:90. 12 Newsham AC, Johnston C, Hall G, et al. Development of an advanced database for clinical trials integrated with an electronic patient record system. Comput Biol Med 2011;41:575–86. 13 Ashley L, Jones H, Velikova G, et al. Cancer patients’ and clinicians’ opinions on the best time in secondary care to approach patients for recruitment to longitudinal questionnaire-based research. Support Care Cancer 2012;20:3365–72. 14 Chester P, Khunti K. Approval times for a multi-centre diabetes study in UK primary care. Diabet Med 2012;29:554–55. 15 Fudge N, Redfern J, Wolfe C, et al. Streamlined research governance: are we there yet? BMJ 2010;341:c4625. 16 Menon U, Gentry-Maharaj A, Ryan A, et al. Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study. BMJ 2008;337. 17 UKCRC Subcommittee for Nurses in Clinical Research (Workforce). Developing the best research professionals— Qualified graduate nurses: recommendations for preparing and supporting clinical academic nurses of the future. London, 2007. 18 Bevans M, Hastings C, Wehrlen L, et al. Defining clinical research nursing practice: results of a role delineation study. CTS-Clin Transl Sci 2011;4:421–27. 19 Cox K, Avis M, Wilson E, et al. An evaluation of the introduction of Clinical Trial Officer roles into the cancer clinical trial setting in the UK. Eur J Cancer Care 2005;14:448–56.
20 Spilsbury K, Petherick E, Cullum N, et al. The role and potential contribution of clinical research nurses to clinical trials. J Cli Nur 2008;17:549–57.
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Using the Clinical Research Network for psychosocial cancer research: lessons learned from two observational studies Penny Wright, Deborah Fenlon, Helen Jones, Claire Foster, Laura Ashley, Kim Chivers Seymour, Galina Velikova, Ikumi Okamoto and Julia Brown BMJ Support Palliat Care 2014 4: 202-211 originally published online August 19, 2013
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Using the Clinical Research Network for psychosocial cancer research: lessons learned from two observational studies Penny Wright,1 Deborah Fenlon,2 Helen Jones,1 Claire Foster,2 Laura Ashley,3 Kim Chivers Seymour,2 Galina Velikova,1 Ikumi Okamoto,2 Julia Brown4
1
Psychosocial Oncology and Clinical Practice Research Group, Leeds Institute for Cancer and Pathology, University of Leeds, Leeds, West Yorkshire, UK 2 Macmillan Survivorship Research Group, Faculty of Health Sciences, University of Southampton, Southampton, UK 3 School of Social, Psychological & Communication Sciences, Faculty of Health and Social Sciences, Leeds Metropolitan University, Leeds, UK 4 Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK Correspondence to Dr Penny Wright, Psychosocial Oncology and Clinical Practice Research Group, Level three Bexley Wing, St James’s Institute of Oncology, St James’s University Hospital, Leeds, West Yorkshire LS9 7TF, UK; [email protected] Received 8 November 2012 Revised 11 June 2013 Accepted 24 July 2013 Published Online First 19 August 2013
To cite: Wright P, Fenlon D, Jones H, et al. BMJ Supportive & Palliative Care 2014;4: 202–211.
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ABSTRACT Background Patient recruitment to psychosocial oncology research has increased but the many studies have been single-site or small-scale. The National Institute for Health Research Clinical Research Network, supports National Institute for Health Research portfolio studies through provision of research staff for recruitment and follow-up. These studies are usually clinical trials of an investigational medicinal product. Psychosocial researchers have little used this resource. Process We report the processes followed and experiences of two psychosocial research teams who recently used the Clinical Research Network, to undertake patient recruitment to two prospective observational studies: electronic Patient-reported Outcomes from Cancer Survivors study (ePOCS) and the ColoREctal Wellbeing study (CREW). Both research groups employed different approaches to using Clinical Research Network support. Outcomes ePOCS secured Comprehensive Local Research Networks funding to appoint ePOCSspecific study research nurses. CREW obtained research support through the National Institute for Health Research Cancer Research Network. Recruitment targets were met (ePOCS n=636; CREW n=1055) despite logistical, administrative and bureaucratic challenges in setting up the studies. Research nurses feedback was mainly positive (ePOCS study only). Top tips for establishing and running psychosocial studies with Clinical Research Network staff are provided and suggestions given for advancing multicentre complex psychosocial studies. Conclusions Some challenges were similar to those in delivery of clinical trials of an investigational medicinal product. The pros and cons of being involved in ePOCS from the
research nurse perspective are also described. Overall the approaches used were successful with both studies reaching their recruitment targets.
INTRODUCTION The importance of psychosocial oncology has been increasingly recognised over recent decades, leading to the Union International for Cancer Control declaring ‘distress’ the 6th vital sign in Cancer Care.1 Despite this, psychosocial care has not become fully integrated into routine cancer care. A number of challenges persist including how psychosocial oncology is valued as a discipline in its own right, the costs of supportive care, and a lack of evidence from large-scale well-designed psychosocial trials.2 In the UK cancer research has been nurtured by the establishment of the National Cancer Research Institute (http://www.ncri.org.uk/) Clinical Studies Groups. Clinical Studies Groups facilitate and prioritise studies to address cancer diagnostic-specific questions (ie, breast, lung) or cross-cutting issues (ie, palliative, psychosocial). The National Institute of Health Research (NIHR) Cancer Research Network (http://www.ncrn.org.uk/), established in parallel with the National Cancer Research Institute, was set up to increase the number of patients participating in high-quality clinical research studies. The NIHR Cancer Research Network comprises 32 Local Research Networks across England and provides an infrastructure to support study participation, including funding for research nurses. Since 2006 their main focus has been on recruitment to clinical trials of an investigational medicinal product randomised controlled trials.
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Features This has led to increased accrual to randomised controlled trials but not at the expense of accrual to observational studies, maybe because some observational studies provide an opportunity for patients to enrol in randomised controlled trials at the same time.3 Timely accrual to randomised controlled trials and observational studies within the cancer trials portfolio has increased significantly since the NIHR Cancer Research Network was established, rising from 20% in 2010.3 Although the majority of trials within the portfolio are clinical trials of an investigational medicinal product there is interest in developing other types of interventional studies.4 The success of the NIHR Cancer Research Network model for supporting clinical trials in England led to the establishment of a generic Clinical Research Network to provide infrastructure for other clinical groups. The elements of the NIHR Clinical Research Network and their inter-relationships and acronyms can be confusing. Figure 1 provides an overview and places the national and local level of networks into context. The NIHR Cancer Research Network-National Cancer Research Institute Clinical Studies Group model for developing and delivering high-quality large-scale trials has worked well for clinical trial evaluation of investigational medicinal products. Some of these trials have either secondary quality of life outcomes as part of the main study or have linked substudies with primary quality of life outcomes which have been very informative. In the disease site-specific Clinical Studies Groups the majority of members are clinicians. The trials become embedded within clinical practice across a number of centres where patients are considered for participation at multidisciplinary team meetings by clinicians and associated research nurses. Across the country there is a network of clinicians who have duty of care for these patients, who are research active and who contribute to accrual of portfolio clinical trials of an investigational medicinal product with support mainly from the NIHR Cancer Research Network. However, this approach is not suitable for many studies where the primary research question addresses psychosocial issues or complex interventions in more depth and in a wide population. The Psychosocial Oncology Clinical Studies Group comprises a varied membership (including health psychology, social work, nursing, clinical trials), few of whom have responsibility for clinical care. The range of studies within the psychosocial oncology portfolio is broad, including studies of interventions from acupuncture to cognitive-behavioural therapy, studies to develop patient decision aids, and observational studies of patients’ quality of life, health behaviours and care experience. There is no readymade clinical infrastructure or experienced study recruitment network to call on for championing multicentre psychosocial studies. In addition, psychosocial studies may require specialist professional input, which is not part of the standard clinical research team, to deliver an intervention or undertake
specialised interviewing or observations. As a result although there have been some high-quality large-scale psychosocial studies,5–7 many studies within the growing Psychosocial Oncology Clinical Studies Group portfolio have been single-site or small-scale and have tended to rely on individual grant-funded appointed research assistants, rather than using network research nurses, for recruitment and follow-up of patients. Now there is an expectation that some research costs will no longer be met by some grant awarding bodies. The recently published Department of Health AcoRD document provides the basis for attributing the costs of health and social care research studies in three categories: research costs (costs of activities undertaken to answer the research questions), National Health Service (NHS) treatment costs (costs of patient care) and NHS support costs (additional patient care costs associated with the research).8 If a study is funded by a charity which is a member of the Association of Medical Research Charities some NHS support costs will be met by the Department of Health, via the networks, such as the identification of patients suitable to approach for participation, obtaining consent and additional assessments. In order for the Psychosocial Oncology Clinical Studies Group to consistently deliver high-quality large-scale observational studies and trials, use of the networks for recruitment support will have to become standard practice. In 2010–2012 two Psychosocial Oncology Clinical Studies Group portfolio observational cohort studies, funded by Macmillan Cancer Support (Association of Medical Research Charities member) and run by University sponsored researchers, collaborated in two different ways with the networks to support recruitment. In the electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) study the research team applied for study-specific funding for research nurses to the generic West Yorkshire Comprehensive Local Research Network; in the ColoREctal Wellbeing (CREW) study the research team asked for expressions of interest for study participation from the NIHR Cancer Research Networks (figure 1). Both studies were given research ethics committee approval (ePOCS (Leeds East 10/H1306/65); CREW (Oxfordshire REC B 10/H0605/31)) and all participants provided written informed consent. We report and compare the different approaches of ePOCS and CREW with the aim of informing researchers of clinical trials which are not an investigational medicinal product of lessons learned and providing recommendations for future studies. THE STUDIES Electronic Patient-reported Outcomes from Cancer Survivors http://public.ukcrn.org.uk/Search/StudyDetail. aspx?StudyID=9403
ePOCS is a secure electronic system for collecting Patient Reported Outcome Measures via the internet at multiple time points and linking these data with
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Figure 1
Overview of the NIHR Clinical Research Network (England) with an emphasis on the Yorkshire Cancer Research Network.
patients’ clinical data transferred from the electronic patient record to the cancer registry and managing associated patient communications electronically.9 The ePOCS study is a prospective observational study to test the feasibility of the ePOCS system, by running it for 2 years in two NHS Trusts within the Yorkshire Cancer Network (the cancer centre and one cancer unit), and using the Northern and Yorkshire Cancer Registry and Information Service.10 To test feasibility, all patients with non-metastatic breast, colorectal and prostate cancer attending the two Yorkshire Cancer Network Trusts within 6 months post diagnosis needed to be considered for recruitment (estimated 204
target n=600). Funding was obtained from the West Yorkshire Comprehensive Local Research Network to appoint research nurses to be embedded within established cancer site-specific clinical research teams to recruit expressly to ePOCS over 1 year. Participants were followed up by the University of Leeds ePOCS research team comprising a Research Lead, Research Fellow and Senior Research Nurse. ColoREctal Wellbeing http://public.ukcrn.org.uk/Search/ StudyDetail.aspx?StudyID=9374
The CREW study is a prospective observational study involving patients with colorectal cancer following
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Features primary surgery using mailed questionnaires. The aim of the study is to establish the natural history of the recovery of health and well-being following treatment for colorectal cancer.11 The CREW team at the University of Southampton included the Research Programme lead, Senior Research Fellow, Research Fellow, Trial Coordinator and Administrator. They worked with cancer centres across wide geographic and sociodemographic areas which could identify, approach and recruit all study-eligible patients to ensure best representation. To recruit a large number of patients (target n=1000) in 1 year the NIHR Cancer Research Network was approached to support study recruitment as part of their local portfolio of studies. Sites were selected on their ability to recruit in a specified way and to recruit at least 2–3 participants weekly. The research nurses recruiting to CREW were established members of clinical research teams, with shared responsibility for recruitment to CREW and to other clinical trials of investigational medicinal products. Both studies
The research nurses recruiting to these studies operated in much the same way as for clinical trials of an investigational medicinal product in terms of collaborating and negotiating with multidisciplinary teams to identify and approach eligible patients. The research nurses informed and consented eligible patients, provided participants with written study information, completed and returned study documentation to the ePOCS or CREW research teams and, for the ePOCS study, entered study events onto a clinical trials database within the electronic patient record.12 Unlike many traditional cancer clinical trials, the research nurses consented and countersigned the consent forms and, for CREW, in some centres were Principal Investigators. Research nurses were not involved with participants after the point of study-consent. Records were kept of the steps undertaken to encourage support for both studies, and of the outcomes of these. In ePOCS, following recruitment completion, the research nurses were interviewed by the ePOCS senior research nurse to find out what it was like to work on ePOCS, how it compared with recruiting to traditional clinical trials, and suggestions as to how the research nurse role might have been improved. Interviews were audio-recorded and opinions collated. ePOCS and Crew study outcomes are being reported in full elsewhere. PROCESSES AND OUTCOMES How the studies were established within centres and networks ePOCS
As ePOCS was a University of Leeds sponsored study the first task was to find managers in each NHS trust to work with the ePOCS research team to make the application for West Yorkshire Comprehensive Local
Research Network funding. Approved funding had to be transacted through a NHS Trust and held by a Trust budget holder. Initially, an application for responsive funding to the West Yorkshire Comprehensive Local Research Network was made on behalf of ePOCS by the Directorate Manager of non-surgical oncology in the Cancer Centre for three Yorkshire Cancer Network whole time equivalent research nurses for 1 year. Later, additional funding was approved by the West Yorkshire Comprehensive Local Research Network for one further whole time equivalent research nurse for 1 year at the cancer unit. There were delays in appointing the research nurses (three full-time posts; two part-time posts), with start dates staggered over 4 months (figure 2A). Reasons included protracted negotiations with the cancer centre Trust to find the staff to manage the budget, a lack of understanding by the ePOCS research team about NHS human resources and financial systems, disjointed communication with human resources concerning the research nurse appointment process and being caught by a 4-month Trust recruitment freeze. In the cancer unit the delay in research nurse appointment was due to the later application for funding. In addition, four of the five appointed research nurses were new to the role, two to the trusts and three to the tumour groups they were recruiting, thus requiring time for induction. The delays and staggered starts meant the recruitment period became asynchronous with the grant period and it was necessary to negotiate a no-cost extension with the funder. CREW
CREW put out a call to the Cancer Research Networks from the NIHR Cancer Research Network Coordinating Centre to complete an ‘Expression of Interest’ form. Sites were selected according to a number of factors including: speed to achieve Research and Development (R&D) approval, ability to recruit good numbers, attendance at a site investigator meeting and demonstration of close working between the clinical and research teams. It was originally planned to recruit from 24 sites, however, not all sites were able to commence recruitment as expected or at the anticipated rate. Therefore the number of participating sites was increased to 30 including further sites being sought from the devolved nations. Thirteen English, two Scottish and two Welsh cancer networks were involved. Methods employed to support the recruiting centres and research nurses ePOCS Set-up
Clinicians were consulted in the development phase of ePOCS.13 A detailed recruitment process map was iteratively created, and checked with the clinical teams. As the research nurses had staggered starts, their training was largely individual and undertaken
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Figure 2
(A) Electronic Patient reported Outcomes from Cancer Survivors (ePOCS) and (B) ColoREctal Wellbeing (CREW) recruitment.
by the ePOCS senior research nurse. In the month before recruitment started, a half-day site investigator meeting was held at the cancer unit (seven attendees). In addition to the protocol, a comprehensive study guide and copies of the recruitment maps were provided for the research nurses. Ongoing support
Ongoing support to the research nurses by the ePOCS senior research nurse (and research fellow in her absence) was provided by telephone, email and weekly 206
visits. Progress review meetings were held at 3 months (11 attendees) and 7 months (4 attendees) into recruitment. A log was kept of study related queries between the ePOCS team and research nurses. The number of research nurse queries was highest at the start of recruitment and fell as the nurses became familiar with study procedures (figure 2A). Eighty-four queries were raised in total, via phone (n=35), email (n=25) or face-to-face (n=23) (one unspecified). Queries concerned eligibility criteria, completion of study events on the electronic patient record, logistical and
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Features administrative tasks and verification of patient email addresses. The ePOCS team sent emails to the clinical teams (and research nurses) following recruitment of every 50th patient, and a congratulatory email on study close. The ePOCS website (http://www.epocs.leeds.ac. uk/) was updated about once a month with study news including recruitment figures and information about academic presentations and publications. CREW Set-up
Sites that joined CREW were sent instructions for recruitment and underwent a telephone conference for study set-up. An initial CREW site investigator meeting was held in the University of Southampton immediately prior to recruitment commencement to inform those who would be involved in CREW recruitment about the study and for them to consider how to ensure they were able to approach every eligible patient in their centre (29 attendees). Ongoing support
All study sites were contacted at least weekly detailing data returns from each site and what was outstanding. A further site investigator meeting was set up after 8 months to update the recruitment staff, and for those who had not had an opportunity to attend the first meeting (21 attendees). There was a final meeting following recruitment closure in order to celebrate reaching the accrual target (24 attendees).The CREW administrative staff had frequent email and telephone contact with all sites. Technical queries were passed onto the study principal investigator or clinical co-investigators. Patient recruitment ePOCS
Despite having planned for a year to setup ePOCS, including time to apply for West Yorkshire Table 1
Comprehensive Local Research Network funding and appointing research nurses, the start date was slightly delayed due to the reasons outlined above, and recruitment took time to become established in all possible clinics. It was anticipated there would be cross-cover within the clinical research teams, such that the ePOCS research nurses would contribute to recruiting to other studies, and other research nurses would help support ePOCS. In reality, there was limited cross-cover undertaken for ePOCS by non-ePOCS research nurses. Active recruitment lasted just over 10 months, 2 months longer than planned, with 636 participants consenting (figure 2A). CREW
In order to ensure research nurses undertook recruitment according to the CREW protocol, the CREW researchers asked the teams to consider their recruitment processes and to write these into their ‘Expression of Interest’ to participate in the study. This was also rehearsed at the site investigator meetings. As R&D approval was protracted in some areas and there were fewer than anticipated eligible patients in some clinics (as estimated by the sites in their expression of interest), the overall recruitment rate was slower than expected. Recruitment lasted 17 months, 5 months longer than planned, with 1055 participants consenting from 29 sites across 17 cancer networks (including 66 participants from a pilot study) (figure 2B). Nurse feedback (ePOCS study only)
The three full-time and one of the two part-time ePOCS research nurses were interviewed at the end of the study. In general the nurses gave positive feedback about their involvement in the ePOCS study, although some downsides were identified (table 1). Four out of the five ePOCS research nurses have continued to
electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) research nurse feedback: top 10 Pros and Cons
Pros
Cons
1. 2.
1.
The research nurses found ePOCS an interesting study. ePOCS research nurses were the experts in the study at multidisciplinary team meeting. 3. Broad eligibility criteria meant large numbers of patients could be approached and recruited. 4. Recruitment criteria allowed a varied time of approach postdiagnosis. 5. ePOCS required no additional hospital visits. 6. Research nurses found ePOCS easier to explain to patients than clinical trials of investigational medicinal products. 7. The ePOCS study was easy for patients to understand. 8. Patients were interested in ePOCS 9. It was easy for patients to make a decision about joining ePOCS. 10. Immediate patient consent was allowed.
The ePOCS research nurses had to put in a lot of effort to get doctors on board. 2. As there was a broad eligibility criteria and there were many clinics to cover. 3. The ePOCS study was not a high priority in clinics. 4. Usually doctors needed reminding to mention to patients about the ePOCS study. 5. Cover for ePOCS research nurse absence was a problem. 6. ePOCS research nurses found it hard to support other portfolio studies as their time was taken up with ePOCS. 7. Obtaining patient notes to file ePOCS consent forms was an issue. 8. No follow-up with patients was a downside. 9. Being involved in ePOCS only could become dissatisfying over time. 10. As with other studies, ePOCS research nurses felt under pressure to recruit which was not so good when recruitment is not going well.
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Features work as research nurses, with one moving into the academic psychosocial research team and the others staying in clinical research teams. Top Tips from lessons learned
Box 1 summarises the top tips learned from these experiences, which would also apply to clinical trials of investigational medicinal products. DISCUSSION Using network resources to underpin recruitment to two prospective observational psychosocial studies was successful with both studies reaching their recruitment targets. Study set-up
The process of engaging the research networks and NHS trusts in these recruitment initiatives was, on occasion, complicated, time-consuming and frustrating for all concerned, but with perseverance and goodwill from individual champions positive outcomes were achieved. Using traditional psychosocial recruitment methods, with grant funded research assistants creates a number of challenges. (1) Financial: the costs of employing research assistants would have been prohibitive for a national multicentre study. (2) Bureaucratic:
the time and negotiations required to enable multiple employers to recruit, induct and line manage research assistants would have been unfeasible. (3) Promotional: the establishment of a psychosocial study, not linked with an existing randomised clinical trial of an investigational medicinal product, led by a research assistant not linked with a clinical team, would have been be extremely difficult. The feedback from the ePOCS research nurses was on the whole positive. The lessons learned from ePOCS and CREW should help non-clinically based academic researchers wishing to undertake psychosocial research in the NHS.
Recruitment challenges
Common to many studies, recruitment took a while to become established and gain momentum. For the ePOCS study this related mainly to the ePOCS team not being experienced in navigating NHS human resources systems, NHS processes slowing research nurse appointments and, as this was a new scenario for the research nurses, a ‘learning’ period was required. As psychosocial researchers become more experienced and familiar with NHS systems, and build relationships with NHS colleagues, some of these challenges will be overcome in future collaborations. Having adequate support from relevant local
Box 1 Top tips for using the Clinical Research Network to support patient recruitment to psychosocial cancer research 1. 2. 3. 4. 5.
6. 7. 8. 9. 10. 11. 12. 13. 14. 15.
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Allow more time than you expect for study set-up. Find local NHS and network champions (clinical and management) with whom to collaborate. For a multicentre study consider the challenges of ensuring your study is included into the local portfolio of a network and appropriately supported by clinical research network staff. If conducting a multicentre study liaise with the national coordinating centre to discuss feasibility and deliverability to develop achievable milestones. For limited site studies consider whether it would be more efficient to seek dedicated clinical research staff (either from existing establishments or through applying for time-limited funding through National Institute of Health Research Comprehensive Local Research Networks). Work closely with local R&D managers and invite them to site investigator meetings where possible. Give as much information as possible in advance so that local teams can make realistic assessments of what is achievable, especially for UK-wide trials. Provide clear and comprehensive resources for the research nurses for their own use, and for them to educate clinical and multidisciplinary team colleagues. Be flexible to accommodate local variation; one size does not fit all. Work with local research nurses and clinical teams to establish best recruitment methods for specific clinical practices. Invest time in training research nurses to undertake recruitment, especially if they are new to post. Respond quickly to research nurse queries and ensure you have senior research team members available to answer complex questions. Create good relationships with clinical staff by developing open communication using a variety of methods (email, fax, face-to-face meetings, phone, website). Regularly provide feedback on local and overall recruitment to networks, clinical teams and research nurses. Arrange study events/workshops for recruiting teams. Celebrate success. Keep the funder up to date with progress and challenges. Thank all involved and acknowledge them in presentations and publications.
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Features organisations (R&D, Comprehensive Local Research Network, trusts and clinical teams) is key for good representative recruitment. Although in principle these organisations support all portfolio-adopted studies, non-clinical studies may be seen as less important than clinical studies. This can lead to a recruitment bias where psychosocial studies may only have access to patients not involved in clinical trials. In the ePOCS study this was not a problem as it was accepted by all parties that patients could be approached about ePOCS even if they were involved in clinical trials. This was more difficult for the CREW study where in some sites recruitment was squeezed due to competing trials. To eliminate this problem, where possible, the CREW team chose sites without competing studies. Uptake of psychosocial studies may be further challenged when the chief and principal investigators are not embedded in clinical services and are not therefore party to the traditional medical model of clinical colleagues supporting each other’s studies. Again, similar to many clinical trials of an investigational medicinal product, one main delay in recruitment to the CREW study was obtaining R&D approvals. Although research governance application and approval processes have improved over the last 10 years, problems with R&D approvals continue to cause delays in many studies.14 15 Despite these initial challenges, accrual targets were met; an important contributory factor may have been the careful attention to planning and trial management as advocated in one multicentre ovarian cancer screening trial.16 The role of the research nurse and others in the research team
The research nurses who undertook recruitment were part of established clinical research teams whose main research activities related to cancer clinical trials, as described by the UK Clinical Research Collaboration.17 The classical role of the research nurse has been defined as covering five main activities: clinical practice, care coordination and continuity, study management, human subject protection and contributing to science, with the most important of these reported by research nurses as being clinical practice and care coordination and continuity.18 In ePOCS and CREW, clinical practice and care coordination and continuity were not part of the research nurse role. In the long term, if research nurses were restricted to involvement with simple consenting for non-interventional studies only, job satisfaction may be compromised, as highlighted in the ePOCS research nurse feedback. The CREW approach may provide a more sustainable model, by providing research nurses with a mixed workload and delivering high recruitment figures which reflect well on the clinical teams and networks. This may have wider benefits by raising awareness of psychosocial studies at multidisciplinary team/clinic
level within a portfolio of classic medical interventions. The CREW approach has been effective in the highest recruiting psychosocial portfolio study to date: the multinational Computerised Adaptive Testing for EORTC-QLQ-C30 (CAT) study (UKCRN ID 5256). Between April 2010 and March 2011 NIHR Cancer Research Network research nurses recruited 1603 participants to CAT across the UK ( personal communication K Poole, 2012). CAT has wide eligibility criteria and requires a single administration of one questionnaire ( personal communication T Young, 2012). CAT, CREW and ePOCS are all simple observational studies where no new skills were required for the research nurses. The ePOCS, CREW and CAT studies described earlier, accounted for 57% of participants recruited to the Psychosocial Oncology Clinical Studies Group portfolio between April 2011 and March 2012. It may be a much more difficult task if there is a need to train research nurses in new skills (eg, for psychosocial intervention studies). Other recruitment models have also been shown to be successful. In the Northern Cancer Research Network, Clinical Trial Officer roles have been developed resulting in increased recruitment to network adopted studies.19 In Southampton, the Macmillan research team has appointed a Macmillan-funded trials coordinator to support their portfolio studies by working within the research team to raise awareness of the processes and clinical realities impacting on non-clinical research. Funding and employment issues
Other challenges to psychosocial research may arise as NIHR/Government funders adhere strictly to AcoRD documents and insist on classifying many of the psychosocial researchers’ tasks as NHS support costs (to be paid for by Comprehensive Local Research Network and done by research nurses in general). As demonstrated in ePOCS, there is considerable administrative burden in study set-up and appointing, training and supporting research nurses. The appointment of research staff (financially supported by the funders) is even more important for these studies and possibly requires more senior researchers with longer contracts. The balance between research and NHS support staff is different for psychosocial studies and should be recognised by researchers and funders. In Leeds, following closure of ePOCS, other West Yorkshire Comprehensive Local Research Network funded research nurses have been appointed to work within the university psychosocial oncology research group rather than within clinical research teams. This approach may be particularly useful for more complex randomised intervention studies which may involve patient tracking, interviewing, delivering interventions and/or audio-recording consultations. Nurses will bring experience and knowledge of communicating with patients and carers, and of the patient experience
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Features and treatment pathways, as well as familiarity with medical terminology and the clinical environment. The psychosocial oncology research team can provide research training and ongoing support and supervision to research nurses appointed in this way. This may help to promote research nurses’ knowledge of research and thus in some cases nurture their transition from research nurses to individuals pursuing their own research career.17 The disadvantage of this approach is the partial separation from clinical teams and resultant research governance issues concerning screening and recruiting patients for trial participation which may require application to the Care Quality Commission National Information Governance Committee (formally National Information and Governance Board for Health and Social Care). It also generates problems with running multicentre psychosocial studies if the research nurses are trained and based for more complex psychosocial studies in one centre only. In addition there may be repercussions for staff. Research nurses who have taken on more complex leadership roles in non-traditional clinical trials have reported challenges with isolation, role conflict, limited cooperation from clinical staff and difficulties maintaining motivation.20 Collaborative networking
Using the networks to support more complex multicentred psychosocial oncology intervention trials will require considerable effort and new ways of working. One way of taking this forward may be to encourage networks active in psychosocial oncology recruitment to identify a staff member to act as a network expert with the remit to encourage development and support of the psychosocial portfolio and liaise with the National Cancer Research Institute Psychosocial Oncology Clinical Studies Group. There are 10 networks which have participated in five or more psychosocial studies ( personal communication K Poole, 2012). Another way will be for members of the Psychosocial Oncology Clinical Studies Group to learn from ours and others’ experiences, work more collaboratively across the Psychosocial Oncology Clinical Studies Group, with site-specific Clinical Studies Groups and with clinical partners, harness the resources of the networks and gradually build expertise across selected networks. By using these approaches psychosocial oncology research in the UK may increase the numbers of large complex multicentre intervention studies. Limitations
In the ePOCS study feedback interviews were undertaken with the research nurses, not possible for the CREW study. Although many of the issues raised are likely to be similar for CREW and ePOCS research nurses there is no way of confirming this. In addition it would have been interesting to have sought opinion 210
from the wider research team members involved in study recruitment to assess the impact of CREW and ePOCS on other clinical research (value for money, time invested and recruitment numbers across all studies). Again this was out with the remit of each study. CONCLUSION The ePOCS and CREW studies have demonstrated that hard work and collaborative working to harness network resources to support psychosocial studies does result in positive outcomes. Many challenges experienced were similar to those found in traditional clinical trials. To achieve parity with clinical trials of investigational medicinal products in front-line clinical research, psychosocial researchers will have to continue investing time and effort to promote the importance and value of psychosocial research to clinical colleagues, train network-research nurses to undertake more complex tasks and deliver well-designed clinical trials with demonstrable patient benefits. Acknowledgements We thank all the patients, staff and the research nurses who supported these studies. We are grateful to Karen Poole and Teresa Young, Mount Vernon Cancer Centre, UK for providing us with personal communications and to Karen Poole, National Institute for Health Research Cancer Research Network, and Eileen Loucaides, National Cancer Research Institute Clinical Studies Groups Secretariat, for their feedback on this article. Contributors Conceived the studies: PW, GV, JB, CF and DF. Designed the studies: PW, GV, JB, LA, HJ, CF and DF. Enrolling participants: LA, HJ, KCS and IO. Data collection, collation and cleaning: LA, HJ, KCS and IO. Data analysis: PW, LA, HJ, KCS and DF. Drafted the paper: PW. Critical revision of the article and approval of the final article: PW, GV, JB, LA, HJ, CF, DF, KCS and IO. Guarantors of the work: PW and CF. Funding This research was funded by Macmillan Cancer Support. Competing interests None. Ethics approval National Research Ethics Service Committee South Central Oxford B (ref. 10/H1306/65), and the University Hospital Southampton NHS Foundation Trust Research and Development Department R&D ref number: RHM CAN0737. Leeds (East) research Ethics Committee10/H1306/65. Provenance and peer review Not commissioned; externally peer reviewed.
REFERENCES 1 Holland J, Watson M, Dunn J. The IPOS New International Standard of Quality Cancer Care: integrating the psychosocial domain into routine care. Psychooncology 2011;20:677–80. 2 Bultz BD, Johansen C. Screening for Distress, the 6th Vital Sign: where are we, and where are we going? Psychooncology 2011;20:569–71. 3 Cameron D, Stead M, Lester N, et al. Research-intensive cancer care in the NHS in the UK. Ann Oncol 2011;22:29–35. 4 Stead M, Cameron D, Lester N, et al. Strengthening clinical cancer research in the United Kingdom. Br J Cancer 2011;104:1529–34. 5 Fallowfield L, Jenkins V, Farewell V, et al. Efficacy of a Cancer Research UK communication skills training model for oncologists: a randomised controlled trial. Lancet 2002;359:650–6.
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Features 6 Velikova G, Booth L, Smith AB, et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 2004;22:714–24. 7 Armes J, Crowe M, Colbourne L, et al. Patients’ supportive care needs beyond the end of cancer treatment: a prospective, longitudinal survey. J Clin Oncol 2009;27:6172–9. 8 Department of Health Research and Development Directorate. Attributing the costs of health and social care Research & Development (AcoRD). Department of Health. London: Crown, 2012. 9 Ashley L, Jones H, Thomas J, et al. Integrating cancer survivors’ experiences into UK cancer registries: design and development of the ePOCS system (electronic Patient-reported Outcomes from Cancer Survivors). Br J Cancer 2011;105(S1): S74–81. 10 Ashley L, Jones H, Forman D, et al. Feasibility test of a UK-scalable electronic system for regular collection of patient-reported outcome measures and linkage with clinical cancer registry data: The electronic Patient-reported Outcomes from Cancer Survivors (ePOCS) system. BMC Med Inform Decis Mak 2011;11:66. 11 Fenlon D, Richardson A, Addington-Hall J, et al. A cohort study of the recovery of health and wellbeing following colorectal cancer (CREW study): protocol paper. BMC Health Serv Res 2012;12:90. 12 Newsham AC, Johnston C, Hall G, et al. Development of an advanced database for clinical trials integrated with an electronic patient record system. Comput Biol Med 2011;41:575–86. 13 Ashley L, Jones H, Velikova G, et al. Cancer patients’ and clinicians’ opinions on the best time in secondary care to approach patients for recruitment to longitudinal questionnaire-based research. Support Care Cancer 2012;20:3365–72. 14 Chester P, Khunti K. Approval times for a multi-centre diabetes study in UK primary care. Diabet Med 2012;29:554–55. 15 Fudge N, Redfern J, Wolfe C, et al. Streamlined research governance: are we there yet? BMJ 2010;341:c4625. 16 Menon U, Gentry-Maharaj A, Ryan A, et al. Recruitment to multicentre trials—lessons from UKCTOCS: descriptive study. BMJ 2008;337. 17 UKCRC Subcommittee for Nurses in Clinical Research (Workforce). Developing the best research professionals— Qualified graduate nurses: recommendations for preparing and supporting clinical academic nurses of the future. London, 2007. 18 Bevans M, Hastings C, Wehrlen L, et al. Defining clinical research nursing practice: results of a role delineation study. CTS-Clin Transl Sci 2011;4:421–27. 19 Cox K, Avis M, Wilson E, et al. An evaluation of the introduction of Clinical Trial Officer roles into the cancer clinical trial setting in the UK. Eur J Cancer Care 2005;14:448–56.
20 Spilsbury K, Petherick E, Cullum N, et al. The role and potential contribution of clinical research nurses to clinical trials. J Cli Nur 2008;17:549–57.
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Using the Clinical Research Network for psychosocial cancer research: lessons learned from two observational studies Penny Wright, Deborah Fenlon, Helen Jones, Claire Foster, Laura Ashley, Kim Chivers Seymour, Galina Velikova, Ikumi Okamoto and Julia Brown BMJ Support Palliat Care 2014 4: 202-211 originally published online August 19, 2013
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