Session: Patient and family engagement in clinical research
Perspectives of Family Caregivers on their Role in Cancer Clinical Trial Decision-Making
Saturday, October 14, 2023
9:00 AM – 10:15 AM ET
Location: Atlantic (Third Floor)
Background: This study engages with key stakeholders that have been overlooked in prior research and discussions surrounding clinical trial decision-making. Family caregivers play a vital role in cancer care by providing daily physical, emotional, and logistical support to patients. Care demands can be amplified in clinical trials by additional medication schedules, interventions, and study visits. Despite the implications of clinical trial participation for caregivers, there is little consensus regarding how they should be included in the informed consent process.
Methods: This ongoing funded qualitative study examines how caregivers perceive their role in clinical trial decision-making and current practices for including them in informed consent. Patients who recently enrolled on a clinical trial were asked to identify a caregiver to join a focus group. Purposive sampling was employed to capture various cancer diagnoses, types of clinical trials, and caregiving situations. Six caregivers participated in the first focus group. Caregivers were asked about their attitudes towards clinical trials, their experiences with the consent process, and their role in decision-making.
Results: Preliminary thematic analysis identified the following themes: lack of alternative treatment options, deference to the patient’s decision, burdens of participation, and relationship with the clinical trials team.
Conclusions: These preliminary findings reinforce the need for caregiver support during consent and trial participation. For trials that impose significant burdens on caregivers, reconceptualization of the current patient-focused consent process by applying the lens of relational autonomy may be necessary.
Susan Mazanec, PhD, RN, AOCN, FAAN – Associate Professor, Nursing, Case Western Reserve University; Barbara Daly, PhD, RN, FAAN – Professor Emerita, Nursing, Case Western Reserve University; Noyonikaa Gupta – Research Assistant, Nursing, Case Western Reserve University; Jennifer Dorth, MD – Physician, Radiation Oncology, University Hospitals; Sana Loue, JD, PhD, MPH, MSSA – Professor, Bioethics, Case Western Reserve University