Increasing Primary Care Physician Support for and Promotion of Cancer Clinical Trials

Abstract

Only 2.5%–3% of adult cancer patients participate in cancer clinical trials, yet about 20% of cancer patients are medically eligible to participate. Research suggests that the primary care provider (PCP) can influence a patient's awareness of, and potentially, his or her decision to consider a clinical trial. To address low cancer clinical trial accrual rates, ‘Imi Hale Native Hawaiian Cancer Network partnered with The Queen's Cancer Center to provide and evaluate education on clinical trials to Hawai‘i PCPs. The educational materials were developed from a national curriculum and tailored to local audiences. Objectives of the curriculum were to educate PCPs about common myths (attitudinal barriers) around clinical trials and suggest ways that PCPs can introduce the concept of clinical trials to their patients with cancer or suspicion of cancer. The curriculum was tested on 128 PCPs in 2012. Knowledge of the PCP's role and their willingness to mention clinical trials were measured through a post-test immediately following the presentation, which 74 (58%) PCPs completed. The post-test results suggested an increase in awareness among PCPs of their potential role in cancer clinical trial accrual, and an increase in PCP willingness to mention clinical trials to their patients with suspicion of cancer or diagnosed with cancer. Although findings suggest that this intervention is useful in increasing PCP receptivity to promoting cancer clinical trials, more research is needed to test if increased willingness results in increased accrual of cancer patients into clinical trials in Hawai‘i.

Introduction

Clinical trials are needed to establish the effectiveness of new therapies for human diseases, including cancer. Participation in cancer clinical trials (CCTs) can increase cancer patient survival rates through the development of better screening methods, earlier detection, and more effective cancer treatments.¹ However, adult enrollment in cancer treatment clinical trials remains low among all demographic groups nationally and in the state of Hawai‘i. Low accrual rates can prolong the duration of trials, delay the analysis or publication of important results, and/or lead to early closure and failure of important studies.^2,3

Nationwide, only 2.5%–3% of adult cancer patients participate in CCTs while receiving treatment for their cancer, yet about 20% of cancer patients are medically eligible to participate.^4–6 In Hawai‘i, approximately 6,000 residents are diagnosed with an invasive cancer each year and, like the national average annual accrual rate, less than 3% of eligible cancer patients participate in cancer treatment clinical trials.^7,8 Of specific concern for Hawai‘i's diverse population is that CCT accrual rates are generally lower among racial and ethnic minorities than among non-Hispanic Whites.⁹ Patients from minority groups or who are 65 or older are less likely to be approached, regardless of eligibility.^{4, 10–14} It has been suggested that increasing minority and under-represented populations in clinical trials is a means to increase representativeness of trials and applicability of findings to diverse populations.¹⁵

A number of barriers negatively affect participation in CCTs.^16–18 One barrier is reluctance of referring physicians to mention and promote CCTs as an option to their patients.^{1, 19–21} For example, a National Cancer Institute survey of 706 Primary Care Physicians (PCPs) found that 98% referred patients to cancer specialists without discussing the topic of clinical trials.¹⁹ The lack of PCP participation in CCT accrual can be partly attributed to the finding that CCTs have the potential to limit physicians' autonomy with patients, which in turn may affect their relationship.²² Another cited barrier is that a physician's decision to recommend a CCT to their patient may be influenced by their knowledge of and attitudes toward specific CCT protocols.^14,23,24 Some PCPs prefer to leave the discussion to the oncologists; some are unaware of available CCTs; some do not discuss CCTs because they refer their patients to specialists who do not conduct CCTs; some PCPs distrust researchers; some feel CCTs are not relevant to their day-to-day medical practice; some feel CCTs are only for patients who have run out of treatment options; and some feel that promoting CCT takes too much time.^{1, 25–29}

Research suggests that active participation of PCPs would improve CCT accrual rates.³⁰ For example, a study by Baquet, et al, found that patients who received information about clinical trials from their health care provider were significantly more likely to participate in clinical trials.³¹ Several researchers recommend the development and testing of educational interventions for physicians.^19,20,³² Sherwood and colleagues found that attendance at CCT education sessions positively predicted eventual referral of cancer patients to clinical trials in Michigan.²¹ The purpose of this study was to tailor a PCP-targeted educational intervention to Hawai‘i physicians and test if it increased PCP awareness about their role in CCT accrual and increased their willingness to discuss CCTs with their patients.

Intervention

‘Imi Hale Native Hawaiian Cancer Network (‘Imi Hale) partnered with The Queen's Cancer Center to tailor, implement and evaluate a 30-minute educational presentation to increase the promotion of CCTs among Hawai‘i PCPs. A curriculum developed by the Education Network to Advance Cancer Clinical Trials (ENACCT) entitled “Why Cancer Clinical Trials are Important for Your Practice: Primary care Provider Education Program” was adapted with permission.⁶ Established in 2004, ENACCT is the only national organization solely dedicated to evidence-based community centered approaches to cancer clinical trials education.³³ ENACCT has developed innovative education programs for community leaders, primary health care providers and clinical trial investigators, offered nationwide. Their mission is to improve access to cancer clinical trials through education and collaboration with communities, health care providers, and researchers.³³ ENACCT and ‘Imi Hale collaborated previously in 2008 to educate community outreach staff and cancer patient navigators about CCT. This paper describes work from a 2012 collaboration to educate PCPs on CCT.

The CCT presentation for PCPs included information about cancer incidence and mortality along with accurate, user-friendly information about CCT. It specifically attempted to disabuse PCPs of common “myths” (attitudinal barriers) pertaining to CCT, including: (1) clinical trials have nothing to do with a PCP's day-to-day medical practice; (2) PCPs have no role to play in encouraging their patients diagnosed with cancer to consider CCTs; (3) clinical trials are only for patients who have run out of other treatment options; (4) patients participating in CCT are treated like “guinea pigs”; (5) there are only a few trials available to patients in Hawai‘i; and (6) helping patients gain access to CCT takes too much time and effort.⁶

Adaptations made to the curriculum by ‘Imi Hale included the addition of Hawai‘i-specific data on colorectal cancer screening, incidence and mortality. For example, data referenced incidence and mortality rates among the different ethnic groups in Hawai‘i, pictures were replaced or added featuring local faces and places, and testimonials were included of Hawai‘i patients who had participated in a CCT. The presentation was developed in two modalities—a PowerPoint^® presentation designed for a staff presentation, and a hand-held, spiral-bound flip chart for one-on-one presentations. Both formats contained identical information. Attendees were provided an information packet that included a printed version of the presentation, patient educational materials about CCT, and information on how to locate a current, open CCT.

The CCT curriculum was designed to take 30 minutes and be presented by a team of two, comprised of a clinical research nurse from The Queen's Medical Center, or clinical research associate from the University of Hawai‘i Cancer Center, and a community health educator from ‘Imi Hale Native Hawaiian Cancer Network. Twelve presenters were trained by ENACCT staff, completing an 8-hour workshop that included brainstorming ways to best reach and address the needs of the target population (PCPs) and role playing to practice and deliver the content. Trainees utilized the original ENACCT curriculum for the training and then participated in adapting and tailoring the curriculum prior to implementation. Drafts of the adapted curriculum were also field-tested with three PCPs to get feedback and reactions on relevance and integrity of the content. When the final tailored presentation and flip chart were completed, all trainees participated in a one-hour session to practice with the new materials.

Methods

Design

This study utilized a post-test-only design, with PCPs completing a short questionnaire following the presentation to assess changes in knowledge of, and willingness to promote cancer clinical trials. Participants were informed that participation was voluntary and that they could withdraw from the study at any time without prejudice. The project was reviewed and exempted by the Native Hawaiian Institutional Review Board.

Sample

The target audience for the in-service was PCPs practicing on O‘ahu. This included board-certified internists and family practitioners, as well as OBGYNs, surgeons, urologists, and other specialists who may play a PCP role for cancer patients. PCPs had a choice of where to receive training: (1) in their offices, where office staff also were invited to attend; (2) over lunch, in a one-on-one session with an educator; or (3) in meetings attended by multiple PCPs, eg, meetings of physicians' associations.

A promotional flyer for the in-service was developed and distributed by the educators trained in the program and by ‘Imi Hale's e-updates and e-newsletters to their network. The trained educators also were responsible to initiate contact and coordinate presentations with PCPs that they knew through their work. PCPs were approached and informed about the free 30-minute education session. The clinical research nurses also outreached to physician groups in Community Health Centers, hospitals, or associations. The sample size was limited to the number of PCPs that were invited and agreed to attend the education sessions.

A total of 16 sessions were held between October 2011 and October 2012 and attended by 128 PCPs and 115 non-physician office staff from across the state. Of the 16 sessions, six were provided in physician offices to the PCP and his/her office staff, three were provided at Community Health Center sites to multiple PCPs and clinic staff, one was provided in a one-on-one session, and nine were provided at physician group meetings (eg, The Queen Medical Center's Department of Medicine and the ‘Ahahui O Na Kauka, an association of Native Hawaiian physicians from across the state). The ‘Ahahui O Na Kauka meeting allowed time for the 30-minute session but other large groups sessions were generally shorter, averaging 15 minutes. The post-test was completed by 74 (58%) of all 128 PCP attendees. Non-PCPs were given a different post-test that evaluated the presentation, and these findings are not presented here.

Measures

Knowledge of their role and willingness to mention CCTs to patients were measured through a PCP-completed post-test (See Appendix). Like the presentation, the questionnaire was adapted from evidence-based materials developed by ENACCT. Changes were measured using three items about the presentation: (1) It increased my awareness of myths about CCT; (2) It increased my awareness of how to bring up CCT in a conversation with my patient; and (3) It increased my knowledge about how I influence my patients' decisions to consider participating in a CCT. Change in willingness to discuss CCT was measured in a single item: This presentation increased my willingness to mention cancer clinical trials more often to my patients. A five-point Likert scale was used for all four questions (Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, and Strongly Agree). PCPs also were asked to indicate their medical specialty. No other demographic information was collected to keep the questionnaire short and increase the likelihood of post-test completion.

Analysis

Post-test data were managed in SPSS® version 21.0.0.0. Frequencies were run for PCP specialty and the four items on knowledge change and willingness to mention CCT to patients. Due to the small sample, “Strongly Agree” and “Agree” were collapsed into a single category labeled “Agree,” while “Strongly Disagree” and “Disagree” were collapsed into a single category labeled “Disagree.” The neutral response category was maintained. Because some sessions were shorter than the recommended 30 minutes, findings by presentation time were compared (30 minutes vs less than 30 minutes).

Results

There were 128 PCPs who received the in-service presentation, with 74 (58%) of participants completing the evaluation. Of the 74 PCPs who completed post-tests, 35 (47%) practiced internal medicine, 10 (14%) practiced family medicine, 8 (11%) were OB-GYNs, 3 (4%) were in pediatrics, 11 (15%) were in other specialty areas (including radiology, anesthesia/pain, optometry, enterology, and general surgery), and 7 (9%) did not indicate their medical specialty (Table 1).

Table 1.

Specialty of physician attendees (N=74)

Specialty	n (%)
Internal medicine	35 (47%)
Family medicine	10 (14%)
OBGYN	8 (11%)
Pediatrics	3 (4%)
Other	11 (15%)
Missing data	7 (9%)
Total	74 (100%)

Results suggested that the in-service presentation was successful in increasing PCPs' awareness about CCT (Table 2). Of the 74 respondents, 61 (82%) agreed that it increased their awareness about CCT myths, 65 (88%) agreed that the presentation increased their awareness about how to bring up cancer clinical trials in a conversation with their patients, and 65 (88%) agreed that the presentation increased their knowledge on how to influence their patients' decision to consider participating in a cancer clinical trial (Table 2). Finally, 64 (87%) agreed that it increased their willingness to mention cancer clinical trials to patients facing cancer. No differences in percent agreeing with each statement were seen for PCPs who attended a 30-minute session vs a session that was shorter (not shown in table).

Table 2.

Responses to the post-test items (N=74)

Item	Agree n (%)	Neutral n (%)	Disagree n (%)
This presentation increased my awareness of myths about cancer clinical trials.	61 (82%)	10 (14%)	3 (4%)
This presentation increased my awareness of how to bring up cancer clinical trials in a conversation with my patient.	65 (88%)	7 (9%)	2 (3%)
This presentation increased my knowledge about how I influence my patients' decision to consider participating in a cancer clinical trial.	65 (88%)	7 (9%)	2 (3%)
This presentation increased my willingness to mention cancer clinical trials more often to my patients.	64 (87%)	7 (9%)	3 (4%)

Oral feedback from attendees suggested that they were very appreciative of the local information included in the training, the sample patient educational materials about CCT, and resources for learning about CCTs available locally. PCPs who practiced on the neighbor islands were especially interested in learning more about local CCTs, as CCT availability is limited where they practice. Other items on the evaluation instrument also reinforce that the training was well received by our target population. For example, 84% of attendees found the presentation to be the appropriate length, 99% of attendees found the format of the presentation easy to follow, and 89% thought that the presentation was appropriate for our target population.

Discussion

CCTs are an important strategy to increasing cancer patient survival rates, which are important for both the patient and the provider.¹ Studies have shown that almost all PCPs (98%) that refer their patients to cancer specialists do not introduce the topic of cancer clinical trials.^{1, 20} In concurrence with Sherwood and colleagues,²¹ this study shows that education directed to PCPs can increase their awareness of their important role in promoting CCTs and increase their willingness to mention CCTs to their patients.

Education on CCT already is being integrated into the education of medical students at the University of Hawai‘i John A. Burns School of Medicine (JABSOM). Since 2006, JABSOM medical students receive a briefing in CCT early in their first year and work through two problem-based learning cases that include a clinical trial component. Second-year students hear from a panel on CCT that includes a physician, a clinical research assistant, and a patient who participated in CCT. The school is also looking into adding a shadowing component to their CCT education efforts. Thus, medical students graduating from JABSOM since 2009 hopefully understand their important role in CCT promotion.

However, many practicing PCPs may not have had education on CCTs in medical school, making this an important topic for continuing medical education. The curriculum tested by The Queen's Medical Center and ‘Imi Hale may be a good continuing education tool.

Although the curriculum was designed to be delivered in a 30-minute session, post-test findings suggest that the shorter session may be just as effective. The shorter sessions occurred at set department meetings, where it was one of many items on the agenda. Only one physician selected one-on-one education over lunch. The health educators delivering the curriculum felt that the most successful deliveries were those provided in-office and in-clinic, which could be attended by the PCPs and their support staff.

In offering the curriculum, it would be important to continue to provide resource materials on locally available CCTs. Although the role of the PCP should be to simply introduce the concept of CCTs to their patients, health educators found that PCPs responded very positively to information provided on active trials in Hawai‘i. This resource would need to be updated regularly. Physicians also appreciated the patient education materials, and these should be made available to their offices.

Limitations

There were several limitations to this study. Most notably, the evaluation tool was administered at the end of the presentation only and relied on self-reported changes. No data were collected on CCT accrual rates, which should be affected by the increases in intermediate indicators (knowledge of role and willingness to discuss CCTs). The evaluation tool does not capture other demographic and professional experience that could be relevant to this study's outcomes, including years of medical experience or previous experience with clinical trials. Findings are based on a convenience sample and may not be representative of all PCPs in the target population. The sample collected may have attracted participants who were already interested in and willing to refer patients to CCTs. Presenters approached physicians with whom they already had relationships, which may have influenced their receptivity to the in-service. Budget restrictions limited the reach of the study to O‘ahu, although there was some participation by neighbor island physicians in the ‘Ahahui O Na Kauka session. Only 58% of attendees completed the post-test. Health educators found that it was logistically more difficult to administer the post-test in large group meetings, so response rates in these sessions were lower than in those provided in the office or clinic.

Conclusion

The results of this study imply that this Hawai‘i-tailored and PCP-targeted curriculum can increase PCP awareness of their important role in CCT accrual and their willingness to mention CCT to their patients facing cancer. Several researchers have found that patients whose physicians mentioned clinical trials were more likely to join them. Future tests of CCT educational programs in Hawai‘i should attempt to link education to CCT accrual outcomes to see if this bears out in our community.

Appendix

Conflict of Interest

None of the authors identify a conflict of interest.