Stakeholder perspectives on the role of caregivers in cancer clinical trial decision-making: results of a qualitative study.

PURPOSE: Family caregivers assist cancer patients in making medical decisions, yet their roles in clinical trial decisions remain understudied. This study aimed to determine how caregivers participate in clinical trial decisions from the perspectives of both caregivers and research staff.

METHODS

Family caregivers of patients offered participation in a clinical trial and clinical trial staff were recruited for focus groups and semi-structured interviews. Participants were asked about caregiver roles in clinical trial decisions and practices of staff to include caregivers during the informed consent process.

RESULTS

Qualitative analysis revealed these caregiver themes: promoting patient autonomy, influential factors, and burdens of participation. Themes specific to clinical trial staff included the following: caregiver role in decision, approaches to caregiver inclusion, caregiver utility to trial staff, and navigating challenging situations. Caregivers reported helping patients make better decisions without influencing them, while clinical trial staff viewed caregivers as highly influential. The hope for therapeutic benefit was a strong motivator for caregivers to support participation in the trial despite burdens they encountered. Clinical trial staff found caregivers to be useful in facilitating communication and adherence to the study protocol.

CONCLUSION

Caregivers should be included early in clinical trial discussions due to their key role in decision-making and facilitating adherence. Clinical trial staff would benefit from training on communication with caregivers and identifying support to alleviate caregiver burden. The cancer research community should explore ways to decrease caregiver burden when possible or provide compensation when caregivers sacrifice time and effort to facilitate clinical trial participation.