Perceptions of Clinical Trial Participation Among Women of Varying Health Literacy Levels

Abstract

Purpose: To understand the perceptions of risk, benefit, and the informed consent process after enrolling in and completing a phase 2 clinical trial using intraoperative radiation therapy (IORT) for early-stage breast cancer, and to determine how perceptions varied based on women's health literacy levels.

Participants & setting: 20 participants who had already completed a phase 2 IORT clinical trial for early-stage breast cancer at an academic medical center.

Methodologic approach: A qualitative descriptive study was conducted using structured interviews consisting of questions aimed to elicit responses from participants regarding experiences of informed consent and the research process. A validated brief health literacy questionnaire was used to determine health literacy levels of participants. The authors analyzed themes using inductive thematic analysis.

Findings: Women with lower levels of health literacy reported feeling confident enough in the provider to make the decision to enroll in the clinical trial during the initial consultation, and, in general, women reported relying heavily on provider recommendation for enrolling in the clinical trial.

Implications for nursing: Tailored approaches for patients with limited health literacy are needed during the clinical trial consent process. Additional longitudinal research with a larger sample size can extend study results and provide insight into the most effective way to modify the informed consent process for patients with limited health literacy.

Keywords: clinical trial consent; clinical trial perceptions; health literacy.