Perceptions of Participation in a Phase I, II, or III Clinical Trial Among African American Patients With Cancer: What Do Refusers Say?

Copyright © 2013 by American Society of Clinical Oncology

Perceptions of Participation in a Phase I, II, or III Clinical Trial Among African American Patients With Cancer: What Do Refusers Say?

1. Richard F. Brown, PhD⇑,
2. Debbie L. Cadet, PhD,
3. Robert H. Houlihan, DHA,
4. Maria D. Thomson, PhD,
5. Emily C. Pratt,
6. Amy Sullivan, EdD and
7. Laura A. Siminoff, PhD

+ Author Affiliations

1. Virginia Commonwealth University School of Medicine; Massey Cancer Center, Virginia Commonwealth University, Richmond, VA; Beth Israel Deaconess Medical Center-Harvard Medical School, Boston, MA

1. Corresponding author: Richard Brown, PhD, Department of Social and Behavioral Health, Virginia Commonwealth University, School of Medicine, MCV Campus, One Capitol Square, 9th Floor, 830 East Main St, PO Box 980149, Richmond, VA 23298; e-mail: rbrown39@vcu.edu.

Abstract

Background: Less than 5% of all adult patients with cancer enter clinical trials. These rates are lower in racial/ethnic minority populations, negatively affecting the generalizability and validity of trial results. Many studies have identified barriers to minority enrolment, yet few have gathered in-depth insights into minority patients’ reasons for trial refusal. We aimed to (1) explore trial refusal reasons in a sample of African American (AA) patients with cancer who declined trial participation and (2) gather patients’ perceptions of the potential benefit of an array of decision support tools.

Methods: Participants were 22 consecutively recruited AA patients with cancer who had declined participation in a therapeutic clinical trial. Within 3 months of the trial refusal decision, participants completed an audio-recorded semistructured interview that asked about demographic and disease information, psychosocial factors, and patients’ experience with clinical trials. Two months later, participants completed a questionnaire that asked about their trial decision.

Results: Few patients received positive recommendations about joining a trial. Patients gave multiple refusal reasons. Only two participants refused to join a clinical trial as a result of issues of mistrust. Most participants refused as a result of fears of additional burdens and adverse effects. Many patients and family members misunderstood trial information. Family members mostly recommended against trial participation. Most patients felt that question prompt lists or decision aids would assist information seeking and decision making.

Conclusion: Low rates of physician recommendations for clinical trial participation of AA patients with cancer warrant further investigation. Interventions to reduce misunderstandings and aid decision making, both within and external to the clinical interaction, need to target both patients and family members.