Medical and Pediatric Oncology 19:165-168 (1991)

Clinical Trials in Cancer Therapy: Efforts to Improve Patient Enrollment by Community Oncologists William B. Fisher, MD, Stuart J.Cohen, EdD, Monica K. Harnmond, Sandra Turner, and Patrick J.Loehrer, MD A prerequisite for the completion of a clinical trial is the accrual of adequate numbers of patients. It i s estimated that over 90-95% of all cancer patients are now treated in their local communities by practicing oncologists and are not seen by primary investigators at teaching hospitals. One risk of this trend is decreased patient enrollment into clinical trials. The private practitioner often lacks the academic oncologist’s incentives to participate in clinical research. The Hoosier Oncology Group (HOG) is composed of community medical and radiation oncologists (85%) and Indiana University faculty members (15%). In an effort to improve patient enrollment onto clinical cancer research trials, HOG has attempted to identify 1) the major obstacles to patient enrollment by community oncolo ists and 2) potential aids to overcome suc$I obsta-

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cles. One hundred fourteen members were surve ed and 75 responded (66%). The major ogstacles were, in descending order: time demands on both the oncologist and his staff; explaining clinical trials to patients; completing flow sheets; perceived increased cost to the patient; remembering protocols; adhering to a rigid protocol. Aids identified as potentially most he1 ful were, in descending order: pocket-size synopses of protocols; com uter generated, individualized prompts; tRe availabili of a clinical trials specialist to explain the c inical trial to patients and assist in obtaining informed consent; the availability of a video tape which could be used to explain clinical trials to patients. These aids are being implemented with the attempt to systemically study their impact on patient accrual.

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Key words: cancer patients, local communities, practicing oncologists

INTRODUCTION

During his Karnofsky lecture to the American Society of Clinical Oncology in 1982, Emil Frei predicted a crisis in clinical cancer research by the year 2000 [I]. It is now estimated that over 90-95% of all cancer patients are treated within their own communities without the benefit of participation in clinical trials [2]. Decreased patient enrollment in clinical trials adversely impacts efforts to improve the overall mortality rate for cancer by clinical researchers. National efforts to overcome this trend by the National Cancer Institute such as cooperative cancer study groups and the development of community clinical oncology programs (CCOP) have fallen short of their goals [4]. The Hoosier Oncology Group (HOG) was formed to meet this increasing crisis in clinical cancer research by linking the research experience of investigators at Indiana University Medical Center with strongly committed community based medical and radiation oncologists. The HOG has successfully engaged practitioners in the design and completion of cancer treatment studies at the com0 1991 Wiley-Liss, Inc.

munity level for the treatment of commonly seen malignancies. Soon after its inception, the HOG became interested in efforts to improve what was considered to be suboptimal patient enrollment into their active clinical trials. The entire membership was surveyed regarding obstacles to patient entry into HOG studies and were asked to rank a series of aids or tools which might be potentially helpful in overcoming these obstacles. This paper will report the results of this survey and discuss the importance of various interventional tools to assist the practicing on-

From the Ball Memorial Hospital, Muncie, Indiana (W.B.F.); Department of Medicine, Indiana University Medical Center (S.J.C., M.K.H., P.J.L.) and Hoosier Oncology Group, Walther Cancer Institute (S.T.), Indianapolis, Indiana. Received September 6, 1990; accepted December 13, 1990. Address reprint requests to Dr. William B. Fisher, Hoosier Oncology Group, Walther Cancer Institute, 3202 North Meridian Street, Indianapolis, IN 46208.

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cologist in becoming an active participant in clinical TABLE I. HOG Survey Results: Perceived Obstacles to Enrolling Patients on Studies* research. METHODOLOGY

The Hoosier Oncology Group (HOG) is a cooperative cancer study group consisting of community based oncologists (85%)and a central core of Indiana University faculty oncologists (15%). The HOG is privately supported by the Walther Cancer Institute (Indianapolis, IN) with its primary focus to serve patients followed by community based onocologists and currently receives no federally funded support. The HOG has developed a series of clinical trials involving standard chemotherapeutic agents and/or radiotherapy for which third party reimbursement has routinely covered requiring active participation by community based oncologists. These trials were specifically designed to allow community oncologists to treat patients with commonly seen malignancies (e.g., colon, lung, breast cancer, lymphoma) in their local communities without referral to research base. To date, accrual in these studies have been'from both community (75%) and university (25%) oncologists. The general membership of the HOG was surveyed regarding: 1) the major perceived obstacles to patient enrollment; and 2) potential tools to overcome such obstacles. These obstacles and tools were selected from suggestions by a small group (W .B.F., P.J.L., S.T.). A list of items (Table I) were ranked as large, small, or no obstacles, and a list of tools (Table 11) ranked numerically in order of preference. Responses were also categorized as faculty versus community based. Based upon the survey results, two interventions were introduced to assist community oncologists in overcoming major obstacles to entering patients into HOG clinical trials. The two interventions selected were pocket-sized protocol synopses containing up-to-date information regarding each HOG clinical trial and individualized computer generated prompts to be included in the patient's chart and to serve as simple reminders regarding treatment timing and data collection. Patient accrual was compared for the periods antedating and following the institution of these interventions.

Time demands on self and staff Explaining clinical trials to patients in specific terms Completing flow sheets Cost to patient Remembering active protocols Mailing follow-up data on time Explaining clinical trials in general terms to patients Recording follow-up data Obtaining on-study tests Choice of theraDies

Community

1.U.a

(N = 63), %

(N = 7), %

35

0

29

14 14 0

22 22 19 17

0 14

17 17 14 14

*Percentages relate to the frequency of selection of the specific item as a large obstacle. al.U.= Indiana University.

TABLE 11. HOG Survey Results: Tools to Assist in Overcoming Obstacles (Listed in Order of Importance) 1. Portable (pocket-sized synopses of protocols

2. Simpler forms (e.g., checklists) 3. Individualized forms specifying tests required, tumor measurements, and dosages of chemotherapy 4. Availability of aclinical trials specialist(e.g., a trained nurse) who could explain to your patients the natureof clinical trials, the particular trial being considered, and assist in obtaining informed consent 5 . Availability of avideotape and equipment which could be used to explain to patients the nature of a clinical trial and its requirements 6. Reimbursement to practice for participation 7. An 800 telephone number at HOG headquarters

and their family members. Furthermore, the respondents to the survey expressed greater difficulty explaining clinical trials in specific terms than in general terms. Concerns regarding data collection (completing flow sheets, mailing follow-up data and obtaining on-study tests) were noted as obstacles for participation. The data collection process overlap with the general cancer about time demands on the oncologist and his staff. Another obstacle to the enrollment of patients into HOG studies was difficulty in remembering which study was active for a particular malignancy. Many of the respondents stated that it was often difficult to remember RESULTS the details of existing clinical trials (patient enrollment Perceived Obstacles criteria, specific information regarding treatment, onOne hundred fourteen questionnaires were mailed and study test requirements, etc.). This problem was of 75 (66%) returned. The surveys were evaluated and particular concern to those respondents who were memresponses were ranked by the frequency of selection bers of more than one cancer study group. (Table I). The time commitment required to participate in clinical trials at the community level was the most Intervention Survey important obstacle identified followed by the difficulty in Table I1 lists the HOG survey results regarding potenexplaining the nature of cancer clinical trials to patients tial tools to overcome the above described obstacles. The

Clinical Trials in Cancer Therapy

Fig. 1. HOG patient accrual.

provision of portable, pocket-sized synopses of active protocols was the tool identified to be most important. The provision of simpler and individualized forms were identified as being potentially helpful in overcoming some of the time demands involved in data collection. Another tool identified as potentially important was the provision of a clinical trial specialist or data manager who could assist the physician by explaining the nature of clinical trials to patients and their family members, and obtaining of informed consent as well as assisting in data collection. The provision of a video tape explaining the rationale and conduct of clinical trials was another identified tool which could serve as an adjunct to the physicians and nurses. Importantly, reimbursement to practice for participation in HOG clinical trials and the provision of an 800 telephone number of HOG headquarters were identified less commonly as potentially helpful. DISCUSSION

The enlarging pool of community based oncologists in the United States has crested a dilemma for clinical

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investigators in cancer therapy. Indeed, an inverse relationship exists between the percentage of cancer patients treated in their local communities and the enrollment of patients into cancer clinical trials. Less than 510% of all newly diagnosed cancer patients in the United States are entered into clinical trials including the commonly seen malignancies (1%-1.5% of available breast cancer, 0.5% of rectal cancer, and 1% of colon cancer patients [3]. Many other authors have reported on the suboptimal recruitment of patients into cancer clinical trials. McCusker et al. reveiwed two ECOG lung cancer chemotherapy protocols active in the early 1970’s [ 5 ] . Seven hundred sixty-seven newly diagnosed lung cancer patients were studied to determine eligibility for and/or entry into these two ECOG protocols. Three hundred twenty-three (42%) were judged eligible for entry into either of the protocols. Sixty-nine (8.9% of total) were actually entered into either of the protocols, and 254 patients who were eligible were not entered. Similar experiences have been reported by others [6,7]. Although many explanations for diminished enrollment of patients into cancer clinical trials have been postulated, little data exist addressing issues among community physicians [3]. Eligibility criteria which are too rigid, lack of compensation and physician disinterest lead the list [4-81. Physician refusal to participate in CCOP trials was found by Hunter to result in the exclusion of approximately 50% of eligible patients [4]. Without addressing the concerns of a growing number of community based oncologists, it is likely that a greater proportion of eligible patients will not enter trials and thus stagnation in clinical cancer research. The Hoosier Oncology Group is a unique organization created to address these concerns by community based oncologists. The results of our survey clearly define significnt obstacles to patient enrollment which are perceived by practicing oncologists. Time demands on the oncologists and his staff, difficulty in explaining clinical trials to patients and family members, the timeconsuming tasks related to data management, and the simple remembering of active protocols are all obstacles which may be successfully addressed. Incorporation of data managers who may assist the physician in the explanation of the specific cancer trials has broad appeal. Recently, the HOG has developed a cooperative venture to support data managers at the offices or hospitals of actively participating oncologists. Continued support will be dependent upon subsequent patient accrual. The introduction of small pocket-sized synopses and computer generated prompts has been implemented with improvement of accrual. Annual accrual to HOG studies has steadily increased since 1984. In 1990, two hundred forty patients entered HOG studies and over 1,100 patients have been entered to date. Similar investigatory efforts by larger cooperative

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groups regarding the participation of community oncologists in cancer research are indicated. Determining the deterences to patient accrual to clinical studies is a common theme across large cooperative groups and various specialties. Those factors, identified as most conducive to such participation, should then be promptly applied to future trials. Continuing dialogue among the academic centers and the community-based physicians address these issues and mandated to ensure success. The Hoosier Oncology Group has become a model of such cooperation. REFERENCES 1. Frei E: Clinical cancer research: an embattled species. Cancer 50: 1979-199 I , 1982.

2. Levine AS: Clinical trials and the community physician. Cancer 5 112498-2502, 1983. 3. Friedman MA: Patient accrual to clinical trials. Cancer Treat Rep 71:557-558, 1987. 4. Hunter CP, Frelick RW, Feldman R, et al.: Selection factors in clinical trials: results from the community clinical program physicians patient log. Cancer Treat Rep 71559-565, 1987. 5 . McCusker J, Was A, Bennett JM: Cancer patient accessions into clinical trials-a pilot investigation into some patient and physician determinants of entry. Am J Clin Oncol 5:227-236, 1982. 6. Lee JYU, Marks JE, Simpson JR: Recruitment of patients to cooperative group clinical trials. Cancer Clin Trials 3:381-384, 1980. 7. Martin JR, Henderson WG, Zacharski LR, et al.: Accrual of patients into a multihospital cancer clinical trial and its implication on planning studies. Am J Clin Oncol 7:173-182, 1984. 8. Lee JY, Breaux SR: Accrual of radiotherapy patients to clinical trials. Cancer 52:1014-1016, 1983.

Clinical trials in cancer therapy: efforts to improve patient enrollment by community oncologists.

A prerequisite for the completion of a clinical trial is the accrual of adequate numbers of patients. It is estimated that over 90-95% of all cancer p...
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