Whose Autonomy Matters? Using Relational Autonomy to Analyze Caregiver Roles in Decision-Making for Cancer Clinical Trials.

Abstract

Background: Participation in a therapeutic clinical trial can be a challenging decision for patients with cancer and their family caregivers. Despite the implications of clinical trials for caregivers, there is little empirical research about how caregivers participate in clinical trial decision-making. This qualitative study sought to identify how caregivers view their role in these decisions and the attitudes and experiences of clinical trial staff regarding inclusion of caregivers in the informed consent process.

Methods: We performed four focus groups-two with clinical trial staff and two with caregivers of patients offered a cancer clinical trial-followed by 15 semi-structured interviews with caregivers. Focus group results informed interview guide development. Transcripts were analyzed using an abductive approach to content analysis, incorporating the theory of relational autonomy.

Results: Caregivers viewed their role as enhancing patient autonomy by helping to interpret clinical trial information and acting as a sounding board. They expressed ambivalence regarding the appropriate degree of influence caregivers should have in the final decision and were cautious not to overly sway patients. Clinical trial staff viewed caregivers as highly influential in decision-making and vital to supporting patient adherence to the study protocol. Caregiver relationships with the oncologist and research staff were influential in their perception of the benefits of the clinical trial and comfort with their loved one participating.

Conclusions: Caregivers' key role in facilitating clinical trial decision-making and protocol adherence merits further attention from bioethicists and researchers. Uncertainty regarding their appropriate decisional role highlights the need for assessment of shared decision-making (SDM) preferences to include caregivers in addition to the traditional patient-physician dyad. Future research should develop and test SDM tools incorporating relational autonomy to identify appropriate decisional roles based on patient-caregiver relationship dynamics and values.