Attitudinal barriers to participation in oncology clinical trials: factor analysis and correlates of barriers

Abstract

Patient participation in cancer clinical trials is low. Little is known about attitudinal barriers to participation, particularly among patients who may be offered a trial during an imminent initial oncology consult. The aims of the present study were to confirm the presence of proposed subscales of a recently developed cancer clinical trial attitudinal barriers measure, describe the most common cancer clinical trials attitudinal barriers, and evaluate socio-demographic, medical and financial factors associated with attitudinal barriers. A total of 1256 patients completed a survey assessing demographic factors, perceived financial burden, prior trial participation and attitudinal barriers to clinical trials participation. Results of a factor analysis did not confirm the presence of the proposed four attitudinal barriers subscale/factors. Rather, a single factor represented the best fit to the data. The most highly-rated barriers were fear of side-effects, worry about health insurance and efficacy concerns. Results suggested that less educated patients, patients with non-metastatic disease, patients with no previous oncology clinical trial participation, and patients reporting greater perceived financial burden from cancer care were associated with higher barriers. These patients may need extra attention in terms of decisional support. Overall, patients with fewer personal resources (education, financial issues) report more attitudinal barriers and should be targeted for additional decisional support.

Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program

“…Our findings support prior studies suggesting that financial concerns represent a major barrier to patient participation in cancer clinical trials [5,36,45]. In a study of 1,256 cancer patients assessing barriers to cancer clinical trial participation, worries about health insurance coverage of clinical care costs represented one of the strongest barriers [36].…”

“…In a study of 1,256 cancer patients assessing barriers to cancer clinical trial participation, worries about health insurance coverage of clinical care costs represented one of the strongest barriers [36]. A second study, which sought to evaluate why patients decline cancer clinical participation, demonstrated that distance from the cancer center and insurance denial were common reasons for refusal to participate [5].…”

“…After we received a CCEP participant's completed survey, we sent a survey to a matched, non-CCEP trial participant.We asked participants to report their financial concerns in the prior 3 months and barriers to clinical trial participation they experienced when considering trial enrollment. The survey contained items from previously validated questions about barriers to clinical trial participation [32][33][34][35][36][37].…”

Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients with Cancer

“…29,30,64 Similar to health care professionals, patients hold attitudes and beliefs that may also affect their willingness to participate and the way they communicate during clinic visits in which trials are discussed. 65,66 Despite this, research shows that, overall, minorities are as likely as whites to consent if they are offered a trial. 30,59,67,68 For example, an assessment of more than 4,000 racially diverse patients with cancer found no significant association between race and ethnicity and refusal to participate in a clinical trial or lack of desire to participate in research.…”

Conducting Biobehavioral Research in Patients With Advanced Cancer: Recruitment Challenges and Solutions

“…Previous reviews have focused on challenges in conducting research with individuals who are at the end of life (Mackin et al, 2009; Steinhauser et al, 2006) or are very old (Townsley, Selby, & Siu, 2005) or with individuals participating in clinical trials for treatment of cancer (Lara et al, 2001; Manne et al, 2015; Wright et al, 2004). Ammari, Hendriksen, and Rydahl-Hansen (2015) described recruitment challenges and reasons for nonparticipation in a family-coping-oriented palliative home care trial with a population recruited from medical, surgical, and oncology hospital wards in Denmark.…”