A Survey of Survivors

Only 3% of cancer patients participate in clinical trials despite the importance of clinical trials in improving cancer treatment and control.

The Patient Advocate Sub-Committee (PASC) of the Cancer and Leukemia Group B's (CALGB) Committee on Advocacy, Research Communication and Ethics (CARE), in collaboration with cancer advocacy organizations, surveyed cancer survivors from July to September 2004 to identify how patients learn about and enroll in trials.

The goal of the survey was to identify opportunities to improve patient enrollment in cancer trials and provide recommendations to improve accrual in CALGB clinical trials. A key challenge to successful cancer clinical trial research is the issue of patient accrual. Poor accrual has been associated with early closure of studies¹ and negative findings.² Therefore, improving trial enrollment is a priority for NCI-funded research groups such as CALGB.

The PASC, comprised of patient advocates affiliated with cancer survivor advocacy organizations and advocates possessing skills and experience in clinical research, identified clinical trial accrual as a primary issue to address within CALGB.

This article presents the findings of the PASC survey and discusses their implications for increasing trial participation among cancer patients.

Survey methods

The survey assessed awareness of, attitudes toward, and sources of knowledge about cancer trials among cancer survivors; documented the factors associated with clinical trial participation and nonparticipation; and assessed how knowledge, attitudes, and willingness to participate in cancer trials are mediated by demographics, such as ethnicity, socioeconomic status, and education.

PASC members developed a survey written at an 8th grade reading level, and the CALGB statistical center staff reviewed it. Multiple choice and open ended questions requiring written comments were included in the survey, and written comments were classified and assigned a number code.

The project was conducted in collaboration with advocacy organizations with which PASC members had ties. Members identified advocacy organizations comprised of cancer survivors who could complete the survey. Each PASC member who identified potential collaborators acted as a liaison to the respective advocacy group. The liaison contacted the advocacy group, explained the project, and assessed the willingness and capacity of the organization to participate. In order to participate, the group needed to inform their membership of the survey and provide access to it.

Liaisons then worked with each organization to identify the most appropriate mechanism to survey their members. Options included posting the survey on the organization's Web site, mailing out the survey to members along with a newsletter, and administering the survey at a scheduled meeting.

The CALGB Web site manager established a link to the survey on each collaborating cancer advocacy organization's Web site. Once posted on the site, cancer survivors could click on the link, complete the survey, and then click on an icon to submit it. Once submitted, online survey responses were emailed to the lead author, a PASC member and project coordinator.

Statistical support staff at Wake Forest University's School of Medicine conducted data analysis. Descriptive analysis was performed on the total sample. Pearson's chi-square tests were used to assess univariate associations of demographic characteristics with clinical trial participants.

Result insights

Sixteen cancer survivor organizations were contacted for their interest in participating in the survey, and 14 participated. Most organizations used their Web site to post the survey and inform their members about the study. One organization sent out a mailing in addition to posting the survey, and one circulated the survey at a scheduled meeting.

A total of 922 surveys were submitted via email, and an additional 35 surveys were mailed in for a total response of 957 surveys over a two-month period. A total of 888 of the submitted surveys contained enough information to analyze, but due to time restrictions, 727 surveys were analyzed. Surveys selected for analysis represented an attempt to maximize demographic diversity, both in type of cancer and ethnicity.

Most respondents were female (67%), Caucasian (88%), and between ages 50 and 59 (32%) (see Table 1). The most common cancer sites reported by survivors were lymphoma, including Waldenstrom's Macroglobulinemia (WM; 28%), breast cancer (28%), and colorectal cancer (15%). Thirty-five percent of those surveyed reported a cancer recurrence.

Table 1. Demographic characteristics of total sample.

Most respondents possessed a higher education, with 67% having a college degree or graduate degree/training. Fewer than 10% had either a high school diploma or less than a high school education. The majority of survivors reported an annual household income range of $50,000 to $79,000 (30%), and regions within the United States were relatively equally represented. Five percent of participants were from other countries: Canada, the UK, Australia, and Puerto Rico.

The remainder of the survey addressed respondents' clinical trial participation, as well as knowledge about and attitudes toward clinical trials. Of the total sample, 33% had either entered or considered entering a clinical trial (n=237) (see Table 2). Of those, nearly three quarters (72%) chose a treatment trial, and 20% entered a symptom management trial. Sixty-five percent agreed to have their blood used in future research; however, 20% did not know if they had given permission to have their blood used in future research.

Table 2. Clinical trial participation and treatment.

Asked to name the person who most influenced their decision regarding trial participation, physicians were cited by 57% of respondents, followed by unspecified others (18%), friends or family (14%), and other cancer survivors (10%).

Sources of trial information

Respondents were asked to list all the ways they had learned about clinical trials (see Table 2). Forty percent of cancer survivors listed a physician as their source of knowledge, and 14% cited other health care personnel. Combined, physicians and other health care personnel were most often cited by respondents (54%) as the way they learned about clinical trials.

The Internet was used by 31% of respondents who searched for a trial, and 16% who used a listserv, news list or chat room. Interestingly, other unspecified individuals (17%) and family or friends (13%) were cited as sources of information about trials more often than either cancer information services (8%) or print media, such as journals and newspapers (4%).

The survey's findings highlight the growing use of the Internet for cancer information. Of those who joined or considered joining a clinical trial, 31% learned about them on the Internet.

Nevertheless, despite the popularity of the Internet, the findings of the study support earlier research^3,4,5,6,7 that identifies the physician as central to clinical trial accrual. In this study, the physician was a primary source of knowledge about clinical trials overall (40%) and exerted the most influence on the decision to enter a cancer clinical trial for the total sample (53%).

In addition, the findings suggest that clinical trial awareness education is needed within cancer centers for both potential trial participants and health care professionals, including referral sites and clinical staff. Examples include incorporating trial information into cancer center initiatives such as patient navigator programs and creating both generic and specific information for referral sites and clinical staff.

Options and demographics

Survivors were asked to identify the options available to them other than clinical trial participation (see Table 2). Most reported that the current standard of care (72%) was an option, and 15% had the option of another clinical trial. The choices "no other option" and "alternative therapy" were each cited by 13% of respondents. Most survivors did not seek a second opinion (67%) about entering the trial, and most believed they understood their disease and the clinical trial extremely well (54%) or moderately well (32%). Treatment options were most often discussed with the physician (94%), other cancer survivors (74%), and family members (70%).

Respondents' expectations from a clinical trial included helping future cancer patients (60%), obtaining the best treatment available (42%), and extending survival while hoping for new therapies (41%). Forty percent considered participating in a clinical trial to obtain the latest therapy, 36% considered a trial to reduce tumor size or slow the spread of cancer, and 35% considered entering a trial to be treated by an expert in the field. The hope for a cure (25%), palliative care (22%), and cancer prevention (11%) were less frequently cited by survey respondents as reasons for clinical trial participation.

Attempts were made to identify demographic characteristics associated with clinical trial participation. Table 3 provides trial participation rates by various demographic characteristics. Lymphoma (65.2%), kidney/bladder cancer (64%), and ovarian (60%) cancer diagnoses were significantly associated with trial participation (p<0.0001). Further, having a cancer recurrence (46.7%, p<0.001) and being male (39%, p<0.02) were also significantly associated with trial participation.

Table 3. Characteristics of respondents associated with clinical trial participation.

Participant similarities

This project aimed to identify factors associated with clinical trial participation among a wide range of cancer survivors. Factors significantly associated with participation included:

• Having a cancer recurrence

• Being male

• Having a cancer diagnosis of lymphoma, kidney/bladder cancer or ovarian cancer.

The cancers associated with greater participation have a poor prognosis and are less common than other cancers.

Reports indicate that only 3% of new breast cancer patients and less than 2% of colorectal cancer patients participated in clinical trials in the United States in 1990.^8,9 Breast and colorectal cancer are more common than lymphoma, kidney/bladder cancer, and ovarian cancer and tend to have a better prognosis. The association of cancer recurrence and trial participation suggests that when standard care fails, physicians often look to clinical trials for treatment options.

As mentioned earlier, the finding that a sample of predominately educated, computer literate cancer survivors most often learned about a clinical trial from their physician suggests that public education about cancer clinical trials is essential to improving enrollment in studies. Cancer centers carry the responsibility to incorporate patient education about clinical trials throughout their entire enterprise, to expand patient education beyond the physician to nursing and support personnel, and to support physicians who want to enroll patients in clinical trials. In this way, clinical trial participation may increase among cancer patients with primary cancer diagnoses and more common forms of the disease.

Navigator programs within clinical cancer centers can be designed with a clinical trial education component and can offer an institutionalized system to inform cancer patients about clinical trial options available to them. General nursing and support staff indirectly involved in clinical trial research can be identified and trained to educate newly diagnosed cancer patients about potential clinical trials and encourage them to address the option with their physician.

Study limitations

This study had several limitations. Technical problems with the online survey resulted in lost data, particularly with responses such as "other" and "specify." Further, the online survey did not require completion of one field before moving on to the next question, resulting in missing data for several questions.

Finally, the study sample is predominately Caucasian, educated, and computer literate. Thus, future research should focus on minority, less educated, and underserved cancer survivors and employ a variety of collection methods.

Acknowledgements

This study was partially funded through a grant from the Coalition of Cancer Cooperative Groups. The author wishes to thank both the Coalition and the Cancer and Leukemia Group B, in particular, for their support of this project.

In addition, the author would like to thank James Lovato, statistician with the department of public health sciences, Wake Forest University School of Medicine, for his contributions to the article, along with the following members of PASC, who also contributed: Kathryn Adams, Sandra Batte, Anne Battershell (staff liaison), Laura Cleveland (co-chair), Deborah Collyar (chair), Edith Fitts, Courtney Hudson, Pamela McAllister, Daniel Moore, Jr., Hank A. Porterfield, Randi Rosenberg, and Jennifer Zelazny (staff liaison).

References

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2. L.J. Costa, A.C. Xavier, A. del Giglio, "Negative Results in Cancer Clinical Trials—Equivalence or Poor Accrual?" Controlled Clinical Trials, 25, 525–533 (2004).

3. A.B. Benson III, J. Prokop-Pregler, J.A. Bean, A.W. Rademaker, B. Eshler, K. Anderson, "Oncologists' Reluctance to Accrue Patients into Clinical Trials: An Illinois Cancer Center Study," Journal of Clinical Oncology, 9 (11) 2067–2075 (November 1991).

4. E.G. Mansour, "Barriers to Clinical Trials Part III: Knowledge and Attitudes of Health Care Providers," Cancer, 74 (9) Suppl. 2672–2675 (1994).

5. E. Paskett, M. Katz, C. DeGraffinreid, C. Tatum, "Participation in Cancer Clinical Trials: Recruitment of Underserved Populations," Clinical Advances in Hematology and Oncology, 1 (10) 607–613 (2003).

6. Harris Interactive, "Misconceptions and Lack of Awareness Greatly Reduce Recruitment for Cancer Clinical Trials," Health Care News, 1 (3) 1–3 (2001).

7. P.M. Ellis, "Attitudes Towards and Participation in Randomized Clinical Trials in Oncology: A Review of the Literature," Annals of Oncology, 11, 939–945 (2000).

8. R.R. Joseph, "Viewpoints and Concerns of a Clinical Trial Participant," Cancer, 74 (9) Suppl. 2692–2693 (1994).

9. P.N. Lara Jr., R. Higdon, N. Lim, K. Kwan, M. Tanaka, D.H.M. Lau, T. Wun, J. Welborn, F.L. Meyers, S. Christensen, R. O'Donnell, C. Richman, S.A. Scudder, J. Tuscano, D.R. Gandara, K.S. Lam, "Prospective Evaluation of Cancer Clinical Trial Accrual Patterns: Identifying Potential Barriers to Enrollment," Journal of Clinical Oncology, 19 (6) 1728–1733 (2001).

Nancy Stark is a member of the Patient Advocate Sub-Committee (PASC) of the Cancer and Leukemia Group B, (360) 370-5725, email: nstark9850@msn.com