# Stakeholder Perspectives on Family Caregiver Involvement in Oncology Clinical Trial Decision-Making

> **NIH NIH R37** · CASE WESTERN RESERVE UNIVERSITY · 2022 · $161,000

## Abstract

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.

## Key facts

- **NIH application ID:** 10591721
- **Project number:** 3R37CA240707-04S1
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Susan Mazanec
- **Activity code:** R37 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $161,000
- **Award type:** 3
- **Project period:** 2019-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10591721

## Citation

> US National Institutes of Health, RePORTER application 10591721, Stakeholder Perspectives on Family Caregiver Involvement in Oncology Clinical Trial Decision-Making (3R37CA240707-04S1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10591721. Licensed CC0.

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