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Journal of Psychosocial Oncology Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/wjpo20
Acceptability, Feasibility and Efficacy of a Supportive Group Intervention for Caregivers of Newly Diagnosed Leukemia Patients a
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Megan E. Pailler , Teresa M. Johnson , Michael A. Zevon , Sarah Kuszczak , Elizabeth d
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Griffiths , James Thompson , Eunice S. Wang & Meir Wetzler a
State University of New York at Buffalo, Buffalo, New York
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Department of Psychosocial Oncology, Roswell Park Cancer Institute, Buffalo, New York
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Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, New York
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Leukemia Section, Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York Accepted author version posted online: 14 Jan 2015.
Click for updates To cite this article: Megan E. Pailler, Teresa M. Johnson, Michael A. Zevon, Sarah Kuszczak, Elizabeth Griffiths, James Thompson, Eunice S. Wang & Meir Wetzler (2015): Acceptability, Feasibility and Efficacy of a Supportive Group Intervention for Caregivers of Newly Diagnosed Leukemia Patients, Journal of Psychosocial Oncology, DOI: 10.1080/07347332.2014.992086 To link to this article: http://dx.doi.org/10.1080/07347332.2014.992086
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ACCEPTED MANUSCRIPT Running head: Leukemia Caregiver Intervention Acceptability, Feasibility and Efficacy of a Supportive Group Intervention for Caregivers of Newly Diagnosed Leukemia Patients Megan E. Paillera, Teresa M. Johnsonb, Michael A. Zevon c, Sarah Kuszczaka, Elizabeth
Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
Griffithsd, James Thompsond, Eunice S. Wangd, Meir Wetzler d a
State University of New York at Buffalo, Buffalo, New York
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Department of Psychosocial Oncology, Roswell Park Cancer Institute, Buffalo, New York
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Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, New York
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Leukemia Section, Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York
CORRESPONDING AUTHOR Megan E. Pailler, Ph.D. Department of Psychology State University of New York at Buffalo 168 Park Hall Buffalo, NY 14260 Phone: 716-645-6888 Fax: 716-645-6186 E-mail: [email protected] Abstract This study describes the development of a supportive group-based intervention for family caregivers of newly diagnosed leukemia patients. We assessed the feasibility, acceptability and efficacy of the group on caregiver distress and quality of life, as well as patient distress utilizing
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ACCEPTED MANUSCRIPT a sequential cohort design comparing a pre-intervention control group with the intervention group. Patients and caregiver dyads completed measures at four time points: within one week of diagnosis (T1), two week follow-up (T2), six week follow-up (T3) and twelve week follow-up (T4). Significant interaction effects were observed for both caregiver distress and quality of life, whereby those receiving the intervention demonstrated improved quality of life and reduced distress over time. Overall, results support the acceptability, feasibility and preliminary efficacy Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
of the group intervention. Keywords: cancer, caregiver, support, intervention, leukemia
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ACCEPTED MANUSCRIPT Introduction There is a growing body of literature demonstrating the impact of a cancer diagnosis on the family. Family caregivers of cancer patients are at high risk for distress, with an estimated 2050% of caregivers suffering significant impairment or mood disturbance as a result of a family member’s cancer (Blanchard, Albrecht, & Ruckdeschel, 1997; Edwards & Clarke, 2004; Vanderwerker et al., 2005). Challenges for the family and caregivers include coping with the Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
initial diagnosis as well as with the prolonged periods of stress associated with treatment, changes in role functioning, and dramatic shifts in established relationships (Nijboer, Triemstra, Tempelaar, Sanderman, & van den Bos, 1999; Rivera, 2009). Cancer caregivers also face significant economic burden, as well as strain on personal and social relationships resulting from significant time commitment of the caregiving role (Girgis, Lambert, Johnson, Waller, & Currow, 2013). Severe fatigue among cancer caregivers is common and linked with caregiver burden(Peters et al., 2014). High caregiver burden has been linked with an increased likelihood of depression among caregivers, as has poor social support and a lack of perceived caregiver competence (Rivera, 2009). Caregivers who are depressed and lacking in social support are more likely to endorse the presence of unmet caregiving needs (Lambert et al., 2012). Family caregivers of cancer patients may also be at increased risk of medical illnesses and morbidity (Northouse, Williams, Given, & McCorkle, 2012). In general, the time around diagnosis has been identified as the period when caregivers experience the greatest need for information and support, as well as the time when caregivers are most likely to report unmet psychosocial needs (Kim & Carver, 2012; Kim, Kashy, Spillers, & Evans, 2010). A recent review of studies examining the extent to which caregivers’ information
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ACCEPTED MANUSCRIPT needs are met emphasized the need for improved access to information for cancer caregivers as well as a concern that such information be conveyed in a caring and compassionate manner (McCarthy, 2011). Compared to the cancer population in general, caregivers of newly diagnosed leukemia patients may have particularly heightened information and support needs since the interval between diagnosis and initial treatment is necessarily short (often less than 24 hours), due to an urgent need for intensive treatment. Furthermore, leukemia patient require extended Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
periods of hospitalization, and the therapy is both highly toxic and of prolonged duration (Bertero, Eriksson, & Ek, 1997a, 1997b). In our clinical work, we have consistently observed significant gaps in information about diagnosis and the course of treatment, as patients and families struggle to process the large amounts of information presented to them in the overwhelming context of a new diagnosis. The positive impact of supportive caregiver interventions is well-documented in the literature (P. L. Hudson, Remedios, & Thomas, 2010; McGrath, 2000; McMillan et al., 2006). Brief interventions providing support to caregivers have been shown to improve caregiver knowledge (Harding et al., 2004), preparedness, perceived competence (P. Hudson, Thomas, Quinn, Cockayne, & Braithwaite, 2009; P. Hudson et al., 2013) and quality of life, as well to decrease caregiver distress (McCorkle & Pasacreta, 2001). The act of sharing experiences with others in a similar situation has been shown to reduce feelings of isolation and alienation, and is perceived as beneficial by participants in such groups (McGrath, 2000). Despite the promise associated with caregiver interventions, recent reviews have highlighted the relative paucity of empirically supported caregiver interventions (Given, Given, & Kozachik, 2001; P. L. Hudson et al., 2010; Romito, Goldzweig, Cormio, Hagedoorn, & Andersen, 2013), and the ongoing need
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ACCEPTED MANUSCRIPT for information and support among caregivers (Harding & Higginson, 2003; P. L. Hudson et al., 2010). Much of this literature has focused on the support needs of caregivers in palliative care settings. Although they may share many needs (e.g. support, knowledge, coping strategies), it is also probable that the needs of caregivers of newly diagnosed patients may be somewhat different, and it is unclear the extent to which findings in the palliative care setting can be generalized to this population. The importance of targeted interventions for caregivers has been Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
documented in the literature (McCorkle & Pasacreta, 2001) and it is likely that caregivers may benefit from specific rather than general information and support. A recent large scale study of preferences for support group topics emphasizes caregivers’ desire for specific cancer information, as well as for assistance dealing with their own symptoms of anxiety and depression (Morse, Gralla, Petersen, & Rosen, 2014). To our knowledge, no such interventions for caregivers of newly diagnosed leukemia patients have been developed or evaluated. The current study sought to assess the acceptability, feasibility and preliminary efficacy of a one-session group intervention designed to provide specific information and support to caregivers of newly diagnosed acute leukemia patients. The content of the intervention was targeted for this population and designed to address unmet needs. We utilized a pre-post sequential cohort design to examine the impact of the intervention on caregivers’ ratings of distress and quality of life over time, compared with a control cohort of caregivers who did not receive the intervention. Finally, we assessed the impact of the intervention on patients’ ratings of distress over time, with the hypothesis that effects of the intervention may generalize to patients’ well-being and result in lower distress. Method
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ACCEPTED MANUSCRIPT Participants Patients and caregivers were considered eligible for the study if the patient was newly diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, or chronic myeloid leukemia in blast crisis phase, and was receiving inpatient induction chemotherapy. Patients were excluded if their medical condition precluded participation, they received outpatient, hospice, or supportive care at diagnosis, or they were not able to identify a primary caregiver. Our intervention was Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
geared specifically toward caregivers of patients receiving inpatient induction treatment, given the unique stressors associated with this treatment course, and the common challenges associated with lengthy hospitalization and subsequent restrictions following discharge. Procedure Participants were approached for enrollment within 48 hours of hospitalization for inpatient induction, and were enrolled in the study if both patients and caregivers agreed to participate and complete study measures. Participants completed questionnaires within one week of hospitalization (T1), and again at two (T2), six (T3), and twelve weeks (T4) after T1. Participants in the intervention cohort attended the intervention between T1 and T2. If caregivers enrolled in the intervention cohort did not attend the intervention, they were excluded from the analysis. The control cohort received standard care, including access to psychosocial support staff (social worker and psychologist), as well as a packet of resource information. The research protocol was approved by the Institutional Review Board, and written informed consent was obtained from each participant (patients and caregivers). Caregiver Intervention
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ACCEPTED MANUSCRIPT The intervention was a 90 minute, one-time meeting including both a structured education component and opportunities for discussion and sharing of experiences. The goal of the program was two-fold: first, to provide caregivers with information about leukemia, course of treatment, caregiving responsibilities and available resources, and second, to allow caregivers an opportunity for networking and support. The program was offered twice per month during the study period. Program materials included a formal presentation with handouts, a “guidebook” Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
containing information covered in the presentation, a list of resources, a calendar/planner, and a relaxation CD for caregivers. The presentation contained four modules: 1) Introductions, 2) Medical Information, 3) Caregiver Coping and 4) Resources. The introduction module included an opportunity for caregivers to informally introduce themselves and share their story. This module also included a formal overview of the structure of the leukemia team and its members as well as a description of their roles. Strategies for communication with the medical team were also presented. The medical information module provided an explanation of leukemia and a general overview of the course of treatment (including initial inpatient induction and subsequent outpatient follow up). In addition to medical information, psychosocial aspects of treatment were discussed in this module, including strategies for supporting the patient and coping with prolonged hospitalization, criteria for discharge, outpatient caregiving responsibilities, and balancing quality of life with treatment. Module three shifted the focus from the patient experience to the experience of the caregiver. This module included discussion of common caregiving stressors and strategies for coping and self-care. Caregivers were encouraged to share what had been challenging for them and how they had overcome these challenges. Module four included an
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ACCEPTED MANUSCRIPT overview of resources within the hospital and in the community, including emotional/support, financial, lodging, transportation and educational resources. Measures: Demographic variables. All participants (patients and caregivers) completed a questionnaire at T1 consisting of age, gender, marital status, race, ethnicity, education level, and relationship to the patient. Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
Distress. The Brief Symptom Inventory-18 (BSI-18), is a shortened version of the 53 item Brief Symptom Inventory, with scales to assess three primary symptom dimensions: Depression, Anxiety, and Somatization, as well as a Global Severity Index (L. R. Derogatis & Melisaratos, 1983; Stefanek, Derogatis, & Shaw). The scale was specifically developed to assess current psychological distress in oncology and community populations and has both adult community and oncology normative data. The Global Severity Index was used as the primary measure of distress in the present study. Community norms were used for caregivers and oncology norms were used for patients The BSI-18 has good test-retest reliability and good internal consistency (Cronbach’s α = 0.89) (L.R. Derogatis, 2000). It correlates highly with other measures of distress, including the Symptom Checklist-90 Revised (SCL-90-R) and adequately distinguishes among distressed and non-distressed individuals. Quality of Life. The Caregiver Quality of Life-Cancer is a 35 item measure used to assess quality of life in a family caregiver of cancer patients. This measure uses a Likert-type scale, which assesses the impact of cancer on a caregiver’s mood, worry, sleep, daily life, family life, and other dimensions, and yields a single QoL score, with high scores reflecting poorer quality of life and low scores reflecting better quality of life. The instrument has good internal
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ACCEPTED MANUSCRIPT consistency (α = .91) and test-retest reliability (α =.95), and has been shown to correlate moderately with measures of overall mental health, emotional distress, burden and patient’s performance status. It has been used with caregivers of lung, breast and prostate cancers, as well as hospice caregiving populations (Weitzner, Jacobsen, Wagner, Friedland, & Cox, 1999). Patient Satisfaction. Intervention participants completed satisfaction surveys following the intervention group. Caregivers rated the overall helpfulness of the program as well as specific Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
aspects of the program on a 5 point likert-type scale. They also provided qualitative descriptions of the aspects of the program that were most helpful, as well as aspects that they would have changed or added. Statistical Analysis: To assess the impact of the intervention on distress and quality of life, A series of repeated measures ANOVAs were planned to compare participants in the intervention group with those in the control group across three study time points (T2-T4) with group status (intervention vs. control) as the between-subjects factor and time as the within subjects factor. Dependent variables included caregiver distress, caregiver quality of life and patient distress. When baseline differences on any of these dependent variables were observed, repeated measures ANCOVAs were used in order to control for these differences. All the tests were two-sided at significance level 0.05. Participants were included in analyses if they had complete data for at least three time points. Group mean imputation was used for instances in which one data point (either T3 or T4) was missed (n=8).
Descriptive statistics from patient satisfaction surveys, as
well as a summary of qualitative findings are also reported. Results
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ACCEPTED MANUSCRIPT A total of 69 caregivers (28 intervention group) and 68 patients (27 intervention group) were included in the present study. During the pre-intervention (control) phase, 86 patients were identified based on diagnosis, 66 of whom met eligibility requirements. During the intervention phase, 94 patients were identified based on diagnosis, 67 of whom met eligibility requirements. Reasons for ineligibility included: Patient too ill (n = 27), opted for outpatient treatment (n = 10), no caregiver available (n = 9), had already attended a caregiver intervention on another service (n Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
= 1). Of eligible dyads, 46 (70%) in the control phase and 39 (58%) in the intervention phase agreed to participate. Reasons for refusal included not interested (35%), too overwhelmed to complete questionnaires (20%), uncomfortable with research (13%), unable to attend the intervention (18%), and initially agreeing but failing to return questionnaires in a timely manner (14%). Participation rates in the control phase were not significantly different from those in the intervention phase (χ2(133)=1.45, p=.23). Five participants in the intervention group who initially agreed to participate did not attend the intervention group and were subsequently withdrawn from the study. Five patients in the control group and 5 patients in the intervention group died prior to T4 and these dyads were not included in analyses. Demographic variables for the intervention and control groups at baseline are presented in Table 1. There were no significant differences in age, gender, race/ethnicity and level of education by intervention status. Descriptive statistics for study outcome measures are presented in Table 2. Caregivers in the intervention group exhibited significantly lower distress [F(1, 67) = 6.60, p = .01], as well as a trend toward higher QoL [F(1, 67) = 3.70, p = .06] at baseline. There were no significant group differences in baseline distress scores among patients [F(1, 66) = 1.39, p = .24].
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ACCEPTED MANUSCRIPT A series of repeated measures ANCOVAs were performed to assess the impact of the intervention on caregiver distress and caregiver QoL, controlling for baseline scores given baseline group differences. There was not a significant main effect of intervention status [F(1, 66) = 2.08, p = .15, η2p = .03]; however, a significant time by intervention status interaction effect was observed [F(2, 132) = 5.90, p = .004, η2p = .08], with greater reductions in distress occurring over time among those in the intervention group (See Figure 1). Follow-up Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
ANCOVAs at each time point indicate that while there were not significant group differences at T2 or T3, differences did emerge at T4 [F(1, 66) = 7.31, p = .01]. For caregiver QoL, a significant main effect of intervention status was observed, with the intervention group demonstrating higher quality of life than those in the control group [F(1, 66) = 5.46, p = .02, η2p = .08].
In addition, a significant time by intervention status interaction effect was observed
[F(2, 132) = 4.60, p = .01, η2p = .07], indicating greater improvements in quality of life over time among those in the intervention group but not in the control group (See Figure 2). Follow-up ANCOVAs at each time point indicate that while there were not significant group differences at T2, significant differences emerged at T3 [F(1, 66) = 6.93, p = .01] and T4 [F(1, 66) = 7.99, p = .008]. A repeated measures ANOVA was performed to assess the impact of the intervention on patient distress. There was no significant main effect of intervention status [F(1, 66) = 2.28, p = .14, η2p = .03], and the time by intervention status interaction was not significant [F(2, 132) = 1.56, p = .21, η2p = .02]. The direction of the findings, however, was similar to that of caregiver distress, with patients in the intervention group demonstrating a trend towards lower distress compared with those in the control group by T4 [F(1, 66) = 3.58, p = .06] (See Figure 3).
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ACCEPTED MANUSCRIPT Patient Satisfaction Overall participant feedback was very positive, with mean overall helpfulness ratings of 4.79 (SD = .44). Caregivers were asked to rate helpfulness of the overview of the leukemia team (M = 4.65, SD = .62), strategies for communication (M=4.63, SD = .57), medical information (M=4.59, SD = .56), treatment information (M=4.69, SD = .51), coping (M=4.63, SD = .61), discharge planning/caring at home (M=4.59, SD = .69), resources for patients and caregivers Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
(M=4.67, SD = .56), and opportunity to meet other caregivers (M=4.53, SD = .81). Caregivers were also asked to provide comments regarding aspects of the program they found helpful as well as suggestions for improvement. Overall caregivers felt the program was well organized and provided the appropriate amount of information. Caregivers reported appreciating the informal, small group format which allowed them the opportunity to ask questions. Medical/treatment information was cited by caregivers as one of the most helpful aspects of the program. Program materials were also identified as a helpful reference throughout treatment. Overall feedback was positive, with few suggestions for improvement. Only two caregivers offered suggestions for improvement; one asked for more medical details, and the other would have liked an example of how to create a profile on a specific caregiver website. Discussion This study sought to assess the feasibility and preliminary efficacy of a one-session group intervention for caregivers of newly diagnosed leukemia patients, a population particularly vulnerable to distress but understudied in the literature (Zimmermann et al., 2013). Evidence for feasibility was encouraging; participation was comparable or higher than caregiver intervention studies in the palliative care context (Harding et al., 2004) and intervention feedback suggested a
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ACCEPTED MANUSCRIPT positive reception by participants. Moreover, our 50% participation rate may actually underestimate the proportion of those who would have attended the group intervention had enrollment not included research related obligations, as many of those who refused participation reported feeling uncomfortable with research questionnaires or too overwhelmed to complete the questionnaires as reasons for refusal. Our intervention also showed promising preliminary evidence of efficacy. Caregivers in Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
the intervention group demonstrated greater reductions in distress and improved quality of life compared to the control group. The significance of the interaction effect for both distress and quality of life suggests that benefits of the group were not apparent immediately after receiving the intervention, but rather, emerged over time. The T3 time point roughly corresponded to the time of discharge from the hospital following inpatient induction, when demands on caregivers increase dramatically. Much of the content of the intervention focused on what to expect after discharge and how to cope with the caregiving role, and as such, it appears that this content may have facilitated coping among those caregivers in the intervention group. Caregiver distress has been associated with high levels of patient dependency and high involvement in caregiving tasks (Nijboer et al., 1999), both aspects of caregiving that likely increase in intensity after the patient is discharged and families take on the primary caregiving role. In addition, caregiver distress and poor quality of life have been linked with perceptions of unmet needs (Friethriksdottir et al., 2011), and caregivers in the intervention group may have felt more prepared to address the challenges faced at home. Distinctions between the acute and chronic phase of cancer treatment have been identified in the literature (Bloom, 2002) with the acute phase characterized by immediate shock and fear, and later phases experienced as more chronic and unrelenting stress.
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ACCEPTED MANUSCRIPT It appears that the benefit of the intervention may have been in preparing caregivers for the more enduring stress associated with the chronic caregiving role. It is not surprising that the intervention had less of an impact on patient distress, given that patients were not the main targets of the intervention. It is noteworthy, however, that the direction of the effects were similar for patients, who by T4 exhibited a trend toward lower distress among those patients whose caregivers had attended the group, suggesting that patient Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
benefits may be linked to improved caregiver functioning over a longer-term period. This finding is consistent with literature demonstrating moderate associations between patient and caregiver distress (Hagedoorn, Sanderman, Bolks, Tuinstra, & Coyne, 2008). This study utilized a quasi-experimental design to assess the impact of the intervention on caregiver distress and quality of life, as well as patient distress. An initial comparison of baseline distress and quality of life indicated a significant difference in groups at baseline, with caregivers in the intervention group displaying lower distress and a trend toward higher quality of life. Given the differential burdens associated with group status (the intervention participants were required to attend the group in addition to completing the questionnaires), it is not surprising that those in the intervention group, evidenced by their willingness to assume these additional responsibilities, displayed less “impairment” at baseline. As such, we statistically controlled for these differences in our efficacy analyses. Ironically, those caregivers who were experiencing the highest levels of role-related strain, and therefore may have benefited most from the intervention, might have declined participation in the study when faced with the additional research based obligations. In addition to impacting participation in the current study, this issue speaks to the important issue that caregivers experiencing the most burden and
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ACCEPTED MANUSCRIPT therefore the most vulnerability may have a more difficult time attending support-based interventions. In light of the intervention efficacy that we observed here, future studies could address this issue by offering a version of the intervention that could be accessed at the caregiver’s convenience, e.g. DVD or web-based format. Although this intervention would not offer the participant the opportunity to engage with other caregivers or to ask questions, it would allow for key components of information to be conveyed and would increase accessibility for Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
those caregivers unable to attend a structured group. Our study has several limitations. Our sample was relatively small. Larger-scale, randomly controlled studies are needed to further determine that effects are related to group assignment rather than a function of cohort. The presence of a control group is a significant strength of the current study; however the lack of random assignment to groups and the presence of bias associated with non-equivalent groups limits the ability to conclusively determine that group differences are due to the intervention exclusively. In addition, inclusion of multiple sites would be necessary to improve the generalizability of current findings. Finally, our study did not stringently control for medical variables such as remission status or duration of hospitalization. Given that we were primarily interested in caregiver outcomes, we opted not to collect this information in order to maximize participant acceptability and keep questionnaires anonymous. Clinical Implications of the Study In conclusion, results of the present study support the feasibility and acceptability of a one-session support and information intervention for caregivers of newly diagnosed leukemia patients, and provide preliminary evidence of the intervention’s efficacy. Such an intervention is cost-effective, well-received by families and may have significant implications on caregivers’
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ACCEPTED MANUSCRIPT adjustment over time. Results suggest that the impact of the intervention may be particularly salient after patients are discharged from the hospital. Our results suggest that future research is warranted in this critically under-examined population. Additional studies are necessary to ensure the efficacy and generalizability of the present findings as well as to develop alternate intervention delivery modalities to allow for maximized engagement by the most vulnerable caregivers. Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
Acknowledgement: This research was supported by Institutional Research Grant #IRG-02-197-07 from the American Cancer Society
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ACCEPTED MANUSCRIPT References: Bertero, C., Eriksson, B. E., & Ek, A. C. (1997a). Explaining different profiles in quality of life experiences in acute and chronic leukemia. Cancer Nursing, 20(2), 100-104. Bertero, C., Eriksson, B. E., & Ek, A. C. (1997b). A substantive theory of quality of life of adults with chronic leukaemia. International Journal of Nursing Studies, 34(1), 9-16. Blanchard, C. G., Albrecht, T. L., & Ruckdeschel, J. C. (1997). The crisis of cancer: Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
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ACCEPTED MANUSCRIPT Hudson, P. L., Remedios, C., & Thomas, K. (2010). A systematic review of psychosocial interventions for family carers of palliative care patients. BMC Palliat Care, 9, 17. Kim, Y., & Carver, C. S. (2012). Recognizing the value and needs of the caregiver in oncology. Current Opinion in Supportive and Palliative Care, 6(2), 280-288. Kim, Y., Kashy, D. A., Spillers, R. L., & Evans, T. V. (2010). Needs assessment of family caregivers of cancer survivors: three cohorts comparison. Psycho-Oncology, 19(6), 573Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
582. Lambert, S. D., Harrison, J. D., Smith, E., Bonevski, B., Carey, M., Lawsin, C., . . . Girgis, A. (2012). The unmet needs of partners and caregivers of adults diagnosed with cancer: a systematic review. BMJ Supportive Palliative Care, 2(3), 224-230. McCarthy, B. (2011). Family members of patients with cancer: what they know, how they know and what they want to know. European Journal of Oncology Nursing, 15(5), 428-441. McCorkle, R., & Pasacreta, J. V. (2001). Enhancing caregiver outcomes in palliative care. Cancer Control, 8(1), 36-45. McGrath, P. (2000). Taking control: findings of a prospective study of an educational course for patients with leukaemia. Supportive Care in Cancer, 8(5), 377-384. McMillan, S. C., Small, B. J., Weitzner, M., Schonwetter, R., Tittle, M., Moody, L., . . . Haley, W. E. (2006). Impact of coping skills intervention with family caregivers of hospice patients with cancer: a randomized clinical trial. Cancer, 106(1), 214-222. Morse, K. D., Gralla, R. J., Petersen, J. A., & Rosen, L. M. (2014). Preferences for cancer support group topics and group satisfaction among patients and caregivers. Journal of Psychosocial Oncology, 32(1), 112-123.
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ACCEPTED MANUSCRIPT Nijboer, C., Triemstra, M., Tempelaar, R., Sanderman, R., & van den Bos, G. A. (1999). Determinants of caregiving experiences and mental health of partners of cancer patients. Cancer, 86(4), 577-588. Northouse, L., Williams, A. L., Given, B., & McCorkle, R. (2012). Psychosocial care for family caregivers of patients with cancer. Journal of Clinical Oncology, 30(11), 1227-1234. Peters, M. E., Goedendorp, M. M., Verhagen, S. A., Smilde, T. J., Bleijenberg, G., & van der Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
Graaf, W. T. (2014). A prospective analysis on fatigue and experienced burden in informal caregivers of cancer patients during cancer treatment in the palliative phase. Acta Oncologica, 1-7. Rivera, H. R. (2009). Depression symptoms in cancer caregivers. Clinical Journal of Oncology Nursing, 13(2), 195-202. Romito, F., Goldzweig, G., Cormio, C., Hagedoorn, M., & Andersen, B. L. (2013). Informal caregiving for cancer patients. Cancer, 119 Suppl 11, 2160-2169. Stefanek, M. E., Derogatis, L. P., & Shaw, A. Psychological distress among oncology outpatients. Prevalence and severity as measured with the Brief Symptom Inventory. Psychosomatics, 28(10), 530-532. Vanderwerker, L. C., Laff, R. E., Kadan-Lottick, N. S., McColl, S., Prigerson, H. G., Vanderwerker, L. C., . . . Prigerson, H. G. (2005). Psychiatric disorders and mental health service use among caregivers of advanced cancer patients.[see comment]. Journal of Clinical Oncology, 23(28), 6899-6907. Weitzner, M. A., Jacobsen, P. B., Wagner, H., Jr., Friedland, J., & Cox, C. (1999). The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an
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ACCEPTED MANUSCRIPT instrument to measure quality of life of the family caregiver of patients with cancer. Quality of Life Research, 8(1-2), 55-63. Zimmermann, C., Yuen, D., Mischitelle, A., Minden, M. D., Brandwein, J. M., Schimmer, A., . . . Rodin, G. (2013). Symptom burden and supportive care in patients with acute leukemia.
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Leukemia Research, 37(7), 731-736.
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Figure Captions: Figure 1: Caregiver Distress over Time
Caregiver Distress Control
58
Intervention
56
Mean Distress
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60
54 52 50 48 46 44 42 40
T2
T3 Time Point
T4
Note: Covariates appearing in the model are evaluated at the following values: T1 Distress = 58.65
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ACCEPTED MANUSCRIPT Figure 2: Caregiver Quality of Life over Time
Caregiver Quality of Life 60
Control
Mean Quality of Life
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58
Intervention
56 54 52 50 48 46 44 42 40
T2
T3 Time Point
T4
Note: Covariates appearing in the model are evaluated at the following values: T1 Quality of Life = 57.10. Lower QoL scores reflect better QoL.
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ACCEPTED MANUSCRIPT Figure 3: Patient Distress over Time
Patient Distress 60
Control
58
Intervention
56
Mean Distress
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54 52 50 48 46 44 42 40
T2
T3 Time Point
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T4
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Table 1: Characteristics of the Sample Caregiver Age M (SD)
Patient
54.6 (14.4)
54.9 (16.0)
Male
30 (43.5)
36 (47.1)
Female
39 (56.5)
32 (52.9)
Caucasian
65 (94.2)
64 (94.1)
Black/African American
2 (2.9)
2 (2.9)
Native American/Alaskan Native
1 (1.4)
2 (2.9)
Less than high school
3 (4.3)
7 (10.3)
High school graduate
26 (37.7)
23 (33.8)
Some college
20 (28.9)
21 (30.8)
College graduate
11 (15.9)
14 (20.6)
Post-graduate
9 (13.0)
3 (4.4)
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Gender n (%)
Race
Education n (%)
Relationship to Patient Spouse
44 (63.8)
Significant Other
7 (10.1)
Parent
9 (13.0)
Other family member
9 (13.0)
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ACCEPTED MANUSCRIPT Table 2: Means and Standard Deviations of Outcome Variables at Baseline and Follow-up Caregiver
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Control
Patient
Intervention
Control
Intervention
Distress T1
61.0 (7.8)
55.2 (11.2)
60.6 (7.9)
58.0 (10.3)
Distress T2
56.0 (9.7)
55.0 (9.2)
56.1 (10.5)
55.9 (7.6)
Distress T3
55.6 (10.4)
48.6 (10.9)
55.9 (10.0)
52.1 (10.8)
Distress T4
54.9 (9.5)
46.5 (10.0)
56.5 (9.4)
51.9 (10.5)
CQoL T1
60.5 (17.1)
52.1 (19.1)
CQoL T2
55.2 (21.7)
47.5 (19.6)
CQoL T3
58.1 (23.1)
40.3 (20.6)
CQoL T4
55.0 (20.0)
37.3 (22.0)
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Journal of Psychosocial Oncology Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/wjpo20
Acceptability, Feasibility and Efficacy of a Supportive Group Intervention for Caregivers of Newly Diagnosed Leukemia Patients a
b
c
a
Megan E. Pailler , Teresa M. Johnson , Michael A. Zevon , Sarah Kuszczak , Elizabeth d
d
d
d
Griffiths , James Thompson , Eunice S. Wang & Meir Wetzler a
State University of New York at Buffalo, Buffalo, New York
b
Department of Psychosocial Oncology, Roswell Park Cancer Institute, Buffalo, New York
c
Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, New York
d
Leukemia Section, Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York Accepted author version posted online: 14 Jan 2015.
Click for updates To cite this article: Megan E. Pailler, Teresa M. Johnson, Michael A. Zevon, Sarah Kuszczak, Elizabeth Griffiths, James Thompson, Eunice S. Wang & Meir Wetzler (2015): Acceptability, Feasibility and Efficacy of a Supportive Group Intervention for Caregivers of Newly Diagnosed Leukemia Patients, Journal of Psychosocial Oncology, DOI: 10.1080/07347332.2014.992086 To link to this article: http://dx.doi.org/10.1080/07347332.2014.992086
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ACCEPTED MANUSCRIPT Running head: Leukemia Caregiver Intervention Acceptability, Feasibility and Efficacy of a Supportive Group Intervention for Caregivers of Newly Diagnosed Leukemia Patients Megan E. Paillera, Teresa M. Johnsonb, Michael A. Zevon c, Sarah Kuszczaka, Elizabeth
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Griffithsd, James Thompsond, Eunice S. Wangd, Meir Wetzler d a
State University of New York at Buffalo, Buffalo, New York
b
Department of Psychosocial Oncology, Roswell Park Cancer Institute, Buffalo, New York
c
Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, New York
d
Leukemia Section, Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York
CORRESPONDING AUTHOR Megan E. Pailler, Ph.D. Department of Psychology State University of New York at Buffalo 168 Park Hall Buffalo, NY 14260 Phone: 716-645-6888 Fax: 716-645-6186 E-mail: [email protected] Abstract This study describes the development of a supportive group-based intervention for family caregivers of newly diagnosed leukemia patients. We assessed the feasibility, acceptability and efficacy of the group on caregiver distress and quality of life, as well as patient distress utilizing
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ACCEPTED MANUSCRIPT a sequential cohort design comparing a pre-intervention control group with the intervention group. Patients and caregiver dyads completed measures at four time points: within one week of diagnosis (T1), two week follow-up (T2), six week follow-up (T3) and twelve week follow-up (T4). Significant interaction effects were observed for both caregiver distress and quality of life, whereby those receiving the intervention demonstrated improved quality of life and reduced distress over time. Overall, results support the acceptability, feasibility and preliminary efficacy Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
of the group intervention. Keywords: cancer, caregiver, support, intervention, leukemia
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ACCEPTED MANUSCRIPT Introduction There is a growing body of literature demonstrating the impact of a cancer diagnosis on the family. Family caregivers of cancer patients are at high risk for distress, with an estimated 2050% of caregivers suffering significant impairment or mood disturbance as a result of a family member’s cancer (Blanchard, Albrecht, & Ruckdeschel, 1997; Edwards & Clarke, 2004; Vanderwerker et al., 2005). Challenges for the family and caregivers include coping with the Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
initial diagnosis as well as with the prolonged periods of stress associated with treatment, changes in role functioning, and dramatic shifts in established relationships (Nijboer, Triemstra, Tempelaar, Sanderman, & van den Bos, 1999; Rivera, 2009). Cancer caregivers also face significant economic burden, as well as strain on personal and social relationships resulting from significant time commitment of the caregiving role (Girgis, Lambert, Johnson, Waller, & Currow, 2013). Severe fatigue among cancer caregivers is common and linked with caregiver burden(Peters et al., 2014). High caregiver burden has been linked with an increased likelihood of depression among caregivers, as has poor social support and a lack of perceived caregiver competence (Rivera, 2009). Caregivers who are depressed and lacking in social support are more likely to endorse the presence of unmet caregiving needs (Lambert et al., 2012). Family caregivers of cancer patients may also be at increased risk of medical illnesses and morbidity (Northouse, Williams, Given, & McCorkle, 2012). In general, the time around diagnosis has been identified as the period when caregivers experience the greatest need for information and support, as well as the time when caregivers are most likely to report unmet psychosocial needs (Kim & Carver, 2012; Kim, Kashy, Spillers, & Evans, 2010). A recent review of studies examining the extent to which caregivers’ information
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ACCEPTED MANUSCRIPT needs are met emphasized the need for improved access to information for cancer caregivers as well as a concern that such information be conveyed in a caring and compassionate manner (McCarthy, 2011). Compared to the cancer population in general, caregivers of newly diagnosed leukemia patients may have particularly heightened information and support needs since the interval between diagnosis and initial treatment is necessarily short (often less than 24 hours), due to an urgent need for intensive treatment. Furthermore, leukemia patient require extended Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
periods of hospitalization, and the therapy is both highly toxic and of prolonged duration (Bertero, Eriksson, & Ek, 1997a, 1997b). In our clinical work, we have consistently observed significant gaps in information about diagnosis and the course of treatment, as patients and families struggle to process the large amounts of information presented to them in the overwhelming context of a new diagnosis. The positive impact of supportive caregiver interventions is well-documented in the literature (P. L. Hudson, Remedios, & Thomas, 2010; McGrath, 2000; McMillan et al., 2006). Brief interventions providing support to caregivers have been shown to improve caregiver knowledge (Harding et al., 2004), preparedness, perceived competence (P. Hudson, Thomas, Quinn, Cockayne, & Braithwaite, 2009; P. Hudson et al., 2013) and quality of life, as well to decrease caregiver distress (McCorkle & Pasacreta, 2001). The act of sharing experiences with others in a similar situation has been shown to reduce feelings of isolation and alienation, and is perceived as beneficial by participants in such groups (McGrath, 2000). Despite the promise associated with caregiver interventions, recent reviews have highlighted the relative paucity of empirically supported caregiver interventions (Given, Given, & Kozachik, 2001; P. L. Hudson et al., 2010; Romito, Goldzweig, Cormio, Hagedoorn, & Andersen, 2013), and the ongoing need
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ACCEPTED MANUSCRIPT for information and support among caregivers (Harding & Higginson, 2003; P. L. Hudson et al., 2010). Much of this literature has focused on the support needs of caregivers in palliative care settings. Although they may share many needs (e.g. support, knowledge, coping strategies), it is also probable that the needs of caregivers of newly diagnosed patients may be somewhat different, and it is unclear the extent to which findings in the palliative care setting can be generalized to this population. The importance of targeted interventions for caregivers has been Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
documented in the literature (McCorkle & Pasacreta, 2001) and it is likely that caregivers may benefit from specific rather than general information and support. A recent large scale study of preferences for support group topics emphasizes caregivers’ desire for specific cancer information, as well as for assistance dealing with their own symptoms of anxiety and depression (Morse, Gralla, Petersen, & Rosen, 2014). To our knowledge, no such interventions for caregivers of newly diagnosed leukemia patients have been developed or evaluated. The current study sought to assess the acceptability, feasibility and preliminary efficacy of a one-session group intervention designed to provide specific information and support to caregivers of newly diagnosed acute leukemia patients. The content of the intervention was targeted for this population and designed to address unmet needs. We utilized a pre-post sequential cohort design to examine the impact of the intervention on caregivers’ ratings of distress and quality of life over time, compared with a control cohort of caregivers who did not receive the intervention. Finally, we assessed the impact of the intervention on patients’ ratings of distress over time, with the hypothesis that effects of the intervention may generalize to patients’ well-being and result in lower distress. Method
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ACCEPTED MANUSCRIPT Participants Patients and caregivers were considered eligible for the study if the patient was newly diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, or chronic myeloid leukemia in blast crisis phase, and was receiving inpatient induction chemotherapy. Patients were excluded if their medical condition precluded participation, they received outpatient, hospice, or supportive care at diagnosis, or they were not able to identify a primary caregiver. Our intervention was Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
geared specifically toward caregivers of patients receiving inpatient induction treatment, given the unique stressors associated with this treatment course, and the common challenges associated with lengthy hospitalization and subsequent restrictions following discharge. Procedure Participants were approached for enrollment within 48 hours of hospitalization for inpatient induction, and were enrolled in the study if both patients and caregivers agreed to participate and complete study measures. Participants completed questionnaires within one week of hospitalization (T1), and again at two (T2), six (T3), and twelve weeks (T4) after T1. Participants in the intervention cohort attended the intervention between T1 and T2. If caregivers enrolled in the intervention cohort did not attend the intervention, they were excluded from the analysis. The control cohort received standard care, including access to psychosocial support staff (social worker and psychologist), as well as a packet of resource information. The research protocol was approved by the Institutional Review Board, and written informed consent was obtained from each participant (patients and caregivers). Caregiver Intervention
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ACCEPTED MANUSCRIPT The intervention was a 90 minute, one-time meeting including both a structured education component and opportunities for discussion and sharing of experiences. The goal of the program was two-fold: first, to provide caregivers with information about leukemia, course of treatment, caregiving responsibilities and available resources, and second, to allow caregivers an opportunity for networking and support. The program was offered twice per month during the study period. Program materials included a formal presentation with handouts, a “guidebook” Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
containing information covered in the presentation, a list of resources, a calendar/planner, and a relaxation CD for caregivers. The presentation contained four modules: 1) Introductions, 2) Medical Information, 3) Caregiver Coping and 4) Resources. The introduction module included an opportunity for caregivers to informally introduce themselves and share their story. This module also included a formal overview of the structure of the leukemia team and its members as well as a description of their roles. Strategies for communication with the medical team were also presented. The medical information module provided an explanation of leukemia and a general overview of the course of treatment (including initial inpatient induction and subsequent outpatient follow up). In addition to medical information, psychosocial aspects of treatment were discussed in this module, including strategies for supporting the patient and coping with prolonged hospitalization, criteria for discharge, outpatient caregiving responsibilities, and balancing quality of life with treatment. Module three shifted the focus from the patient experience to the experience of the caregiver. This module included discussion of common caregiving stressors and strategies for coping and self-care. Caregivers were encouraged to share what had been challenging for them and how they had overcome these challenges. Module four included an
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ACCEPTED MANUSCRIPT overview of resources within the hospital and in the community, including emotional/support, financial, lodging, transportation and educational resources. Measures: Demographic variables. All participants (patients and caregivers) completed a questionnaire at T1 consisting of age, gender, marital status, race, ethnicity, education level, and relationship to the patient. Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
Distress. The Brief Symptom Inventory-18 (BSI-18), is a shortened version of the 53 item Brief Symptom Inventory, with scales to assess three primary symptom dimensions: Depression, Anxiety, and Somatization, as well as a Global Severity Index (L. R. Derogatis & Melisaratos, 1983; Stefanek, Derogatis, & Shaw). The scale was specifically developed to assess current psychological distress in oncology and community populations and has both adult community and oncology normative data. The Global Severity Index was used as the primary measure of distress in the present study. Community norms were used for caregivers and oncology norms were used for patients The BSI-18 has good test-retest reliability and good internal consistency (Cronbach’s α = 0.89) (L.R. Derogatis, 2000). It correlates highly with other measures of distress, including the Symptom Checklist-90 Revised (SCL-90-R) and adequately distinguishes among distressed and non-distressed individuals. Quality of Life. The Caregiver Quality of Life-Cancer is a 35 item measure used to assess quality of life in a family caregiver of cancer patients. This measure uses a Likert-type scale, which assesses the impact of cancer on a caregiver’s mood, worry, sleep, daily life, family life, and other dimensions, and yields a single QoL score, with high scores reflecting poorer quality of life and low scores reflecting better quality of life. The instrument has good internal
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ACCEPTED MANUSCRIPT consistency (α = .91) and test-retest reliability (α =.95), and has been shown to correlate moderately with measures of overall mental health, emotional distress, burden and patient’s performance status. It has been used with caregivers of lung, breast and prostate cancers, as well as hospice caregiving populations (Weitzner, Jacobsen, Wagner, Friedland, & Cox, 1999). Patient Satisfaction. Intervention participants completed satisfaction surveys following the intervention group. Caregivers rated the overall helpfulness of the program as well as specific Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
aspects of the program on a 5 point likert-type scale. They also provided qualitative descriptions of the aspects of the program that were most helpful, as well as aspects that they would have changed or added. Statistical Analysis: To assess the impact of the intervention on distress and quality of life, A series of repeated measures ANOVAs were planned to compare participants in the intervention group with those in the control group across three study time points (T2-T4) with group status (intervention vs. control) as the between-subjects factor and time as the within subjects factor. Dependent variables included caregiver distress, caregiver quality of life and patient distress. When baseline differences on any of these dependent variables were observed, repeated measures ANCOVAs were used in order to control for these differences. All the tests were two-sided at significance level 0.05. Participants were included in analyses if they had complete data for at least three time points. Group mean imputation was used for instances in which one data point (either T3 or T4) was missed (n=8).
Descriptive statistics from patient satisfaction surveys, as
well as a summary of qualitative findings are also reported. Results
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ACCEPTED MANUSCRIPT A total of 69 caregivers (28 intervention group) and 68 patients (27 intervention group) were included in the present study. During the pre-intervention (control) phase, 86 patients were identified based on diagnosis, 66 of whom met eligibility requirements. During the intervention phase, 94 patients were identified based on diagnosis, 67 of whom met eligibility requirements. Reasons for ineligibility included: Patient too ill (n = 27), opted for outpatient treatment (n = 10), no caregiver available (n = 9), had already attended a caregiver intervention on another service (n Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
= 1). Of eligible dyads, 46 (70%) in the control phase and 39 (58%) in the intervention phase agreed to participate. Reasons for refusal included not interested (35%), too overwhelmed to complete questionnaires (20%), uncomfortable with research (13%), unable to attend the intervention (18%), and initially agreeing but failing to return questionnaires in a timely manner (14%). Participation rates in the control phase were not significantly different from those in the intervention phase (χ2(133)=1.45, p=.23). Five participants in the intervention group who initially agreed to participate did not attend the intervention group and were subsequently withdrawn from the study. Five patients in the control group and 5 patients in the intervention group died prior to T4 and these dyads were not included in analyses. Demographic variables for the intervention and control groups at baseline are presented in Table 1. There were no significant differences in age, gender, race/ethnicity and level of education by intervention status. Descriptive statistics for study outcome measures are presented in Table 2. Caregivers in the intervention group exhibited significantly lower distress [F(1, 67) = 6.60, p = .01], as well as a trend toward higher QoL [F(1, 67) = 3.70, p = .06] at baseline. There were no significant group differences in baseline distress scores among patients [F(1, 66) = 1.39, p = .24].
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ACCEPTED MANUSCRIPT A series of repeated measures ANCOVAs were performed to assess the impact of the intervention on caregiver distress and caregiver QoL, controlling for baseline scores given baseline group differences. There was not a significant main effect of intervention status [F(1, 66) = 2.08, p = .15, η2p = .03]; however, a significant time by intervention status interaction effect was observed [F(2, 132) = 5.90, p = .004, η2p = .08], with greater reductions in distress occurring over time among those in the intervention group (See Figure 1). Follow-up Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
ANCOVAs at each time point indicate that while there were not significant group differences at T2 or T3, differences did emerge at T4 [F(1, 66) = 7.31, p = .01]. For caregiver QoL, a significant main effect of intervention status was observed, with the intervention group demonstrating higher quality of life than those in the control group [F(1, 66) = 5.46, p = .02, η2p = .08].
In addition, a significant time by intervention status interaction effect was observed
[F(2, 132) = 4.60, p = .01, η2p = .07], indicating greater improvements in quality of life over time among those in the intervention group but not in the control group (See Figure 2). Follow-up ANCOVAs at each time point indicate that while there were not significant group differences at T2, significant differences emerged at T3 [F(1, 66) = 6.93, p = .01] and T4 [F(1, 66) = 7.99, p = .008]. A repeated measures ANOVA was performed to assess the impact of the intervention on patient distress. There was no significant main effect of intervention status [F(1, 66) = 2.28, p = .14, η2p = .03], and the time by intervention status interaction was not significant [F(2, 132) = 1.56, p = .21, η2p = .02]. The direction of the findings, however, was similar to that of caregiver distress, with patients in the intervention group demonstrating a trend towards lower distress compared with those in the control group by T4 [F(1, 66) = 3.58, p = .06] (See Figure 3).
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ACCEPTED MANUSCRIPT Patient Satisfaction Overall participant feedback was very positive, with mean overall helpfulness ratings of 4.79 (SD = .44). Caregivers were asked to rate helpfulness of the overview of the leukemia team (M = 4.65, SD = .62), strategies for communication (M=4.63, SD = .57), medical information (M=4.59, SD = .56), treatment information (M=4.69, SD = .51), coping (M=4.63, SD = .61), discharge planning/caring at home (M=4.59, SD = .69), resources for patients and caregivers Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
(M=4.67, SD = .56), and opportunity to meet other caregivers (M=4.53, SD = .81). Caregivers were also asked to provide comments regarding aspects of the program they found helpful as well as suggestions for improvement. Overall caregivers felt the program was well organized and provided the appropriate amount of information. Caregivers reported appreciating the informal, small group format which allowed them the opportunity to ask questions. Medical/treatment information was cited by caregivers as one of the most helpful aspects of the program. Program materials were also identified as a helpful reference throughout treatment. Overall feedback was positive, with few suggestions for improvement. Only two caregivers offered suggestions for improvement; one asked for more medical details, and the other would have liked an example of how to create a profile on a specific caregiver website. Discussion This study sought to assess the feasibility and preliminary efficacy of a one-session group intervention for caregivers of newly diagnosed leukemia patients, a population particularly vulnerable to distress but understudied in the literature (Zimmermann et al., 2013). Evidence for feasibility was encouraging; participation was comparable or higher than caregiver intervention studies in the palliative care context (Harding et al., 2004) and intervention feedback suggested a
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ACCEPTED MANUSCRIPT positive reception by participants. Moreover, our 50% participation rate may actually underestimate the proportion of those who would have attended the group intervention had enrollment not included research related obligations, as many of those who refused participation reported feeling uncomfortable with research questionnaires or too overwhelmed to complete the questionnaires as reasons for refusal. Our intervention also showed promising preliminary evidence of efficacy. Caregivers in Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
the intervention group demonstrated greater reductions in distress and improved quality of life compared to the control group. The significance of the interaction effect for both distress and quality of life suggests that benefits of the group were not apparent immediately after receiving the intervention, but rather, emerged over time. The T3 time point roughly corresponded to the time of discharge from the hospital following inpatient induction, when demands on caregivers increase dramatically. Much of the content of the intervention focused on what to expect after discharge and how to cope with the caregiving role, and as such, it appears that this content may have facilitated coping among those caregivers in the intervention group. Caregiver distress has been associated with high levels of patient dependency and high involvement in caregiving tasks (Nijboer et al., 1999), both aspects of caregiving that likely increase in intensity after the patient is discharged and families take on the primary caregiving role. In addition, caregiver distress and poor quality of life have been linked with perceptions of unmet needs (Friethriksdottir et al., 2011), and caregivers in the intervention group may have felt more prepared to address the challenges faced at home. Distinctions between the acute and chronic phase of cancer treatment have been identified in the literature (Bloom, 2002) with the acute phase characterized by immediate shock and fear, and later phases experienced as more chronic and unrelenting stress.
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ACCEPTED MANUSCRIPT It appears that the benefit of the intervention may have been in preparing caregivers for the more enduring stress associated with the chronic caregiving role. It is not surprising that the intervention had less of an impact on patient distress, given that patients were not the main targets of the intervention. It is noteworthy, however, that the direction of the effects were similar for patients, who by T4 exhibited a trend toward lower distress among those patients whose caregivers had attended the group, suggesting that patient Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
benefits may be linked to improved caregiver functioning over a longer-term period. This finding is consistent with literature demonstrating moderate associations between patient and caregiver distress (Hagedoorn, Sanderman, Bolks, Tuinstra, & Coyne, 2008). This study utilized a quasi-experimental design to assess the impact of the intervention on caregiver distress and quality of life, as well as patient distress. An initial comparison of baseline distress and quality of life indicated a significant difference in groups at baseline, with caregivers in the intervention group displaying lower distress and a trend toward higher quality of life. Given the differential burdens associated with group status (the intervention participants were required to attend the group in addition to completing the questionnaires), it is not surprising that those in the intervention group, evidenced by their willingness to assume these additional responsibilities, displayed less “impairment” at baseline. As such, we statistically controlled for these differences in our efficacy analyses. Ironically, those caregivers who were experiencing the highest levels of role-related strain, and therefore may have benefited most from the intervention, might have declined participation in the study when faced with the additional research based obligations. In addition to impacting participation in the current study, this issue speaks to the important issue that caregivers experiencing the most burden and
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ACCEPTED MANUSCRIPT therefore the most vulnerability may have a more difficult time attending support-based interventions. In light of the intervention efficacy that we observed here, future studies could address this issue by offering a version of the intervention that could be accessed at the caregiver’s convenience, e.g. DVD or web-based format. Although this intervention would not offer the participant the opportunity to engage with other caregivers or to ask questions, it would allow for key components of information to be conveyed and would increase accessibility for Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
those caregivers unable to attend a structured group. Our study has several limitations. Our sample was relatively small. Larger-scale, randomly controlled studies are needed to further determine that effects are related to group assignment rather than a function of cohort. The presence of a control group is a significant strength of the current study; however the lack of random assignment to groups and the presence of bias associated with non-equivalent groups limits the ability to conclusively determine that group differences are due to the intervention exclusively. In addition, inclusion of multiple sites would be necessary to improve the generalizability of current findings. Finally, our study did not stringently control for medical variables such as remission status or duration of hospitalization. Given that we were primarily interested in caregiver outcomes, we opted not to collect this information in order to maximize participant acceptability and keep questionnaires anonymous. Clinical Implications of the Study In conclusion, results of the present study support the feasibility and acceptability of a one-session support and information intervention for caregivers of newly diagnosed leukemia patients, and provide preliminary evidence of the intervention’s efficacy. Such an intervention is cost-effective, well-received by families and may have significant implications on caregivers’
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ACCEPTED MANUSCRIPT adjustment over time. Results suggest that the impact of the intervention may be particularly salient after patients are discharged from the hospital. Our results suggest that future research is warranted in this critically under-examined population. Additional studies are necessary to ensure the efficacy and generalizability of the present findings as well as to develop alternate intervention delivery modalities to allow for maximized engagement by the most vulnerable caregivers. Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
Acknowledgement: This research was supported by Institutional Research Grant #IRG-02-197-07 from the American Cancer Society
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ACCEPTED MANUSCRIPT References: Bertero, C., Eriksson, B. E., & Ek, A. C. (1997a). Explaining different profiles in quality of life experiences in acute and chronic leukemia. Cancer Nursing, 20(2), 100-104. Bertero, C., Eriksson, B. E., & Ek, A. C. (1997b). A substantive theory of quality of life of adults with chronic leukaemia. International Journal of Nursing Studies, 34(1), 9-16. Blanchard, C. G., Albrecht, T. L., & Ruckdeschel, J. C. (1997). The crisis of cancer: Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
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ACCEPTED MANUSCRIPT Girgis, A., Lambert, S., Johnson, C., Waller, A., & Currow, D. (2013). Physical, psychosocial, relationship, and economic burden of caring for people with cancer: a review. Journal of Oncology Practice, 9(4), 197-202. Given, B. A., Given, C. W., & Kozachik, S. (2001). Family support in advanced cancer. CA: A Cancer Journal for Clinicians, 51(4), 213-231. Hagedoorn, M., Sanderman, R., Bolks, H. N., Tuinstra, J., & Coyne, J. C. (2008). Distress in Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
couples coping with cancer: a meta-analysis and critical review of role and gender effects. Psychological Bulletin, 134(1), 1-30. Harding, R., & Higginson, I. J. (2003). What is the best way to help caregivers in cancer and palliative care? A systematic literature review of interventions and their effectiveness. Palliative Medicine, 17(1), 63-74. Harding, R., Higginson, I. J., Leam, C., Donaldson, N., Pearce, A., George, R., . . . Taylor, L. (2004). Evaluation of a short-term group intervention for informal carers of patients attending a home palliative care service. Journal of Pain Symptom Management, 27(5), 396-408. Hudson, P., Thomas, T., Quinn, K., Cockayne, M., & Braithwaite, M. (2009). Teaching family carers about home-based palliative care: final results from a group education program. Journal of Pain Symptom Management, 38(2), 299-308. Hudson, P., Trauer, T., Kelly, B., O'Connor, M., Thomas, K., Summers, M., . . . White, V. (2013). Reducing the psychological distress of family caregivers of home-based palliative care patients: short-term effects from a randomised controlled trial. Psycho-Oncology, 22(9), 1987-1993.
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ACCEPTED MANUSCRIPT Hudson, P. L., Remedios, C., & Thomas, K. (2010). A systematic review of psychosocial interventions for family carers of palliative care patients. BMC Palliat Care, 9, 17. Kim, Y., & Carver, C. S. (2012). Recognizing the value and needs of the caregiver in oncology. Current Opinion in Supportive and Palliative Care, 6(2), 280-288. Kim, Y., Kashy, D. A., Spillers, R. L., & Evans, T. V. (2010). Needs assessment of family caregivers of cancer survivors: three cohorts comparison. Psycho-Oncology, 19(6), 573Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
582. Lambert, S. D., Harrison, J. D., Smith, E., Bonevski, B., Carey, M., Lawsin, C., . . . Girgis, A. (2012). The unmet needs of partners and caregivers of adults diagnosed with cancer: a systematic review. BMJ Supportive Palliative Care, 2(3), 224-230. McCarthy, B. (2011). Family members of patients with cancer: what they know, how they know and what they want to know. European Journal of Oncology Nursing, 15(5), 428-441. McCorkle, R., & Pasacreta, J. V. (2001). Enhancing caregiver outcomes in palliative care. Cancer Control, 8(1), 36-45. McGrath, P. (2000). Taking control: findings of a prospective study of an educational course for patients with leukaemia. Supportive Care in Cancer, 8(5), 377-384. McMillan, S. C., Small, B. J., Weitzner, M., Schonwetter, R., Tittle, M., Moody, L., . . . Haley, W. E. (2006). Impact of coping skills intervention with family caregivers of hospice patients with cancer: a randomized clinical trial. Cancer, 106(1), 214-222. Morse, K. D., Gralla, R. J., Petersen, J. A., & Rosen, L. M. (2014). Preferences for cancer support group topics and group satisfaction among patients and caregivers. Journal of Psychosocial Oncology, 32(1), 112-123.
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ACCEPTED MANUSCRIPT Nijboer, C., Triemstra, M., Tempelaar, R., Sanderman, R., & van den Bos, G. A. (1999). Determinants of caregiving experiences and mental health of partners of cancer patients. Cancer, 86(4), 577-588. Northouse, L., Williams, A. L., Given, B., & McCorkle, R. (2012). Psychosocial care for family caregivers of patients with cancer. Journal of Clinical Oncology, 30(11), 1227-1234. Peters, M. E., Goedendorp, M. M., Verhagen, S. A., Smilde, T. J., Bleijenberg, G., & van der Downloaded by [Selcuk Universitesi] at 04:47 27 January 2015
Graaf, W. T. (2014). A prospective analysis on fatigue and experienced burden in informal caregivers of cancer patients during cancer treatment in the palliative phase. Acta Oncologica, 1-7. Rivera, H. R. (2009). Depression symptoms in cancer caregivers. Clinical Journal of Oncology Nursing, 13(2), 195-202. Romito, F., Goldzweig, G., Cormio, C., Hagedoorn, M., & Andersen, B. L. (2013). Informal caregiving for cancer patients. Cancer, 119 Suppl 11, 2160-2169. Stefanek, M. E., Derogatis, L. P., & Shaw, A. Psychological distress among oncology outpatients. Prevalence and severity as measured with the Brief Symptom Inventory. Psychosomatics, 28(10), 530-532. Vanderwerker, L. C., Laff, R. E., Kadan-Lottick, N. S., McColl, S., Prigerson, H. G., Vanderwerker, L. C., . . . Prigerson, H. G. (2005). Psychiatric disorders and mental health service use among caregivers of advanced cancer patients.[see comment]. Journal of Clinical Oncology, 23(28), 6899-6907. Weitzner, M. A., Jacobsen, P. B., Wagner, H., Jr., Friedland, J., & Cox, C. (1999). The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an
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ACCEPTED MANUSCRIPT instrument to measure quality of life of the family caregiver of patients with cancer. Quality of Life Research, 8(1-2), 55-63. Zimmermann, C., Yuen, D., Mischitelle, A., Minden, M. D., Brandwein, J. M., Schimmer, A., . . . Rodin, G. (2013). Symptom burden and supportive care in patients with acute leukemia.
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Leukemia Research, 37(7), 731-736.
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Figure Captions: Figure 1: Caregiver Distress over Time
Caregiver Distress Control
58
Intervention
56
Mean Distress
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60
54 52 50 48 46 44 42 40
T2
T3 Time Point
T4
Note: Covariates appearing in the model are evaluated at the following values: T1 Distress = 58.65
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ACCEPTED MANUSCRIPT Figure 2: Caregiver Quality of Life over Time
Caregiver Quality of Life 60
Control
Mean Quality of Life
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58
Intervention
56 54 52 50 48 46 44 42 40
T2
T3 Time Point
T4
Note: Covariates appearing in the model are evaluated at the following values: T1 Quality of Life = 57.10. Lower QoL scores reflect better QoL.
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ACCEPTED MANUSCRIPT Figure 3: Patient Distress over Time
Patient Distress 60
Control
58
Intervention
56
Mean Distress
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54 52 50 48 46 44 42 40
T2
T3 Time Point
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T4
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Table 1: Characteristics of the Sample Caregiver Age M (SD)
Patient
54.6 (14.4)
54.9 (16.0)
Male
30 (43.5)
36 (47.1)
Female
39 (56.5)
32 (52.9)
Caucasian
65 (94.2)
64 (94.1)
Black/African American
2 (2.9)
2 (2.9)
Native American/Alaskan Native
1 (1.4)
2 (2.9)
Less than high school
3 (4.3)
7 (10.3)
High school graduate
26 (37.7)
23 (33.8)
Some college
20 (28.9)
21 (30.8)
College graduate
11 (15.9)
14 (20.6)
Post-graduate
9 (13.0)
3 (4.4)
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Gender n (%)
Race
Education n (%)
Relationship to Patient Spouse
44 (63.8)
Significant Other
7 (10.1)
Parent
9 (13.0)
Other family member
9 (13.0)
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ACCEPTED MANUSCRIPT Table 2: Means and Standard Deviations of Outcome Variables at Baseline and Follow-up Caregiver
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Control
Patient
Intervention
Control
Intervention
Distress T1
61.0 (7.8)
55.2 (11.2)
60.6 (7.9)
58.0 (10.3)
Distress T2
56.0 (9.7)
55.0 (9.2)
56.1 (10.5)
55.9 (7.6)
Distress T3
55.6 (10.4)
48.6 (10.9)
55.9 (10.0)
52.1 (10.8)
Distress T4
54.9 (9.5)
46.5 (10.0)
56.5 (9.4)
51.9 (10.5)
CQoL T1
60.5 (17.1)
52.1 (19.1)
CQoL T2
55.2 (21.7)
47.5 (19.6)
CQoL T3
58.1 (23.1)
40.3 (20.6)
CQoL T4
55.0 (20.0)
37.3 (22.0)
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