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Grant Details

Grant Number: 3R37CA240707-04S1 Interpret this number
Primary Investigator: Mazanec, Susan
Organization: Case Western Reserve University
Project Title: Stakeholder Perspectives on Family Caregiver Involvement in Oncology Clinical Trial Decision-Making
Fiscal Year: 2022


Project Summary/Abstract Current informed consent practices for oncology clinical trials focus on individual autonomy and fail to account for the complex obligations and relationships that influence decision-making. Family caregivers are influential in medical decision-making for cancer patients, yet little is known regarding how they are included in clinical trial discussions and what is important to them when considering participation. Clinical trial staff are primarily responsible for informed consent in oncology trials and maintain ongoing contact with patients and caregivers, yet they are also overlooked in clinical trial decision-making research. This study aims to fill this knowledge gap using qualitative methodology to elicit perspectives from family caregivers and clinical trial staff, key stakeholders in oncology clinical trial decision-making. The specific aims are: (1) to understand how family caregivers of patients with cancer conceptualize their role in clinical trial decision making, (2) to determine factors influential to family caregivers of patients with cancer during the clinical trial decision-making process, and (3) to identify attitudes, beliefs, and approaches used by clinical trial staff to navigate family caregiver involvement in the informed consent process for clinical trials. Two focus groups will be conducted, one with oncology clinical trial staff and one with family caregivers of patients with cancer. Thematic analysis of focus group data will refine interview guides for subsequent semi-structured interviews with family caregivers. Results will inform future bioethics research, policies, and practice regarding inclusion of family caregivers in clinical trial informed consent processes.


None. See parent grant details.

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