"Why I Said No": Trial-Eligible Patient Perspectives on Declining Breast Cancer Clinical Trial Participation.

Abstract

Clinical trials play an important role in the advancement of breast cancer detection and treatment, in turn improving patient outcomes. However, less than 20% of eligible patients participate in clinical trials. Understanding patient perspectives regarding their decision is critical for identifying and addressing barriers to improve trial accessibility and engagement. This qualitative content analysis used semistructured interviews with 21 female patients with breast cancer who were eligible for and declined clinical trial participation from July 2020 to January 2024. Interviews were conducted via Zoom, transcribed verbatim, and open coding was used to develop the codebook with NVivo V14 software. Transcribed interviews were coded deductively by two independent reviewers. Thematic saturation was achieved. Of 21 patients, 43% and 57% declined participation in therapeutic and nontherapeutic trials, respectively. Three major themes with associated subthemes emerged as key reasons for declining participation: (1) fear, including fear of the unknown, concerns about side effects and potential costs associated, and skepticism regarding trial medication effectiveness; (2) mistrust, regarding medical research, historical injustices, and pharmaceutical companies; and (3) additional burdens of trial participation, such as time commitment, travel constraints, financial concerns, and existing health-related challenges. Declining participation in clinical trials is complex and multifactorial. The most cited reasons for declining participation included fear, mistrust, and logistical burdens. These findings highlight the importance of developing targeted strategies to address both emotional and logistical barriers, particularly for vulnerable populations, ensuring that research outcomes are representative, equitable, and generalizable to all patients.