Patient and Caregiver Recommendations for Person-Centered Oncology Clinical Trial Design: A Qualitative Study
Author(s)
Samantha Pollard, BA, MSc, PhD1, Sarah Scruton, MSc2, Asli Ozer, MA3, Summer Konechny, .4, Randy Thompson, .4, Rosilene Kraft, .4, Chiquita Hessels, .5, Robin Urquhart, PhD6.
1Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada, 2Nova Scotia Health, Halifax, NS, Canada, 3Department of Sociology & Anthropology, Simon Fraser University, Burnaby, BC, Canada, 4Patient Partner, Halifax, NS, Canada, 5Li Fraumeni Association, Vancouver, BC, Canada, 6Dalhousie University, Halifax, NS, Canada.
1Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, Canada, 2Nova Scotia Health, Halifax, NS, Canada, 3Department of Sociology & Anthropology, Simon Fraser University, Burnaby, BC, Canada, 4Patient Partner, Halifax, NS, Canada, 5Li Fraumeni Association, Vancouver, BC, Canada, 6Dalhousie University, Halifax, NS, Canada.
OBJECTIVES: Cancer clinical trials are challenged by low participant accrual and retention. Robust and timely evidence for novel therapeutics depends on patient participation and adherence to protocols. However, clinical trial designs do not reflect patient preferences, expectations, and informational needs. To address this challenge, we qualitatively explored patient and caregiver reported challenges and barriers to cancer clinical trial participation, and recommendations for improved design.
METHODS: We conducted virtual focus groups and interviews with adult patients with cancer and caregivers. Participants were recruited for variation in geography, ethnicity, age, trial experience, and gender. Sessions were audio recorded, professionally transcribed, and coded using Nvivo software. Thematic analysis was conducted by two three qualitative researchers. Data collection and analysis were conducted concurrently, with recruitment continuing until thematic saturation was reached. All study documentation and methods were co-developed by a patient advisory committee, established at project outset. Patient members assisted in the interpretation of study findings.
RESULTS: Five focus groups and 10 interviews (n=34) were conducted throughout 2025. Patients and caregivers identified substantial barriers to trial participation including 1) a lack of awareness about available trials, 2) travel and out-of-pocket cost, 3) fragmented and inflexible data collection procedures, 4) opaque consent documentation, and 5) a lack of trust and communication between patients, caregivers, and healthcare providers. Notably, caregivers described feeling immense pressure and difficulty managing decision-making alongside supporting patient physical and mental health. Consistently, both patients and caregivers recommended decentralized data collection and improved logistical and mental health support throughout the research trajectory.
CONCLUSIONS: Clinical trial consent procedures and data collection does not meet the needs of patients and caregivers. Recommendations generated through this study are undergoing extensive critical review by patients, trialists and other trial interest-holders to co-develop a patient-driven clinical trial design framework for pan-Canadian implementation.
METHODS: We conducted virtual focus groups and interviews with adult patients with cancer and caregivers. Participants were recruited for variation in geography, ethnicity, age, trial experience, and gender. Sessions were audio recorded, professionally transcribed, and coded using Nvivo software. Thematic analysis was conducted by two three qualitative researchers. Data collection and analysis were conducted concurrently, with recruitment continuing until thematic saturation was reached. All study documentation and methods were co-developed by a patient advisory committee, established at project outset. Patient members assisted in the interpretation of study findings.
RESULTS: Five focus groups and 10 interviews (n=34) were conducted throughout 2025. Patients and caregivers identified substantial barriers to trial participation including 1) a lack of awareness about available trials, 2) travel and out-of-pocket cost, 3) fragmented and inflexible data collection procedures, 4) opaque consent documentation, and 5) a lack of trust and communication between patients, caregivers, and healthcare providers. Notably, caregivers described feeling immense pressure and difficulty managing decision-making alongside supporting patient physical and mental health. Consistently, both patients and caregivers recommended decentralized data collection and improved logistical and mental health support throughout the research trajectory.
CONCLUSIONS: Clinical trial consent procedures and data collection does not meet the needs of patients and caregivers. Recommendations generated through this study are undergoing extensive critical review by patients, trialists and other trial interest-holders to co-develop a patient-driven clinical trial design framework for pan-Canadian implementation.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR169
Topic
Health Service Delivery & Process of Care, Patient-Centered Research, Study Approaches
Topic Subcategory
Patient Behavior and Incentives, Patient Engagement
Disease
Oncology, Personalized & Precision Medicine