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

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  • Additional Information
    • Source:
      Publisher: Oncology Nursing Society Country of Publication: United States NLM ID: 7809033 Publication Model: Print Cited Medium: Internet ISSN: 1538-0688 (Electronic) Linking ISSN: 0190535X NLM ISO Abbreviation: Oncol Nurs Forum Subsets: MEDLINE
    • Publication Information:
      Publication: Pittsburgh, PA : Oncology Nursing Society
      Original Publication: New York, Oncology Nursing Society.
    • Subject Terms:
      Health Literacy*; Breast Neoplasms/*psychology ; Breast Neoplasms/*radiotherapy ; Clinical Trials as Topic/*psychology ; Clinical Trials as Topic/*statistics & numerical data ; Patient Participation/*psychology ; Patient Participation/*statistics & numerical data; Aged ; Aged, 80 and over ; Female ; Humans ; Middle Aged ; Qualitative Research ; Surveys and Questionnaires ; Virginia
    • 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.
    • Contributed Indexing:
      Keywords: clinical trial consent; clinical trial perceptions; health literacy
    • Publication Date:
      Date Created: 20200418 Date Completed: 20210526 Latest Revision: 20210526
    • Publication Date:
      20240104
    • Accession Number:
      10.1188/20.ONF.273-280
    • Accession Number:
      32301926