Considering the caregiver in early-phase clinical trials: a review of trial protocols and consent forms

Informal caregivers of patients enrolled in early-phase clinical trials (EP-CTs) devote an average of fifty or more hours per week to providing care, but qualitative studies suggest they perceive receiving limited instruction about their role. However, no work has evaluated what formal guidance EP-CT caregivers might receive during enrollment. This study characterized the type and granularity of information provided to EP-CT caregivers in study documents.

We manually reviewed informed consent and study protocol documents for adult EPCTs registered on ClinicalTrials.gov completed 1990-2025 with both documents available. Using a structured codebook from prior work [26], we identified whether trials delineated expectations for caregivers regarding: (1) participation in informed consent processes and learning about the study, (2) structured education in trial tasks (i.e., medication administration), (3) attendance at trial visits, (4) monitoring trial adherence, (5) symptom surveillance/management, (6) communicating with the study team, and (7) available supportive care resources. Descriptive statistics summarized provided caregiver content.

Overall, 145 EP-CT trials (66.9% solid only, 26.2% hematologic only, 6.9% mixed) were evaluated. Regarding EP-CT learning, only 8/145 (5.5%) of studies delineated study team commitment to explicitly discussing study details with caregivers if desired. Only 14/145 (9.7%) of studies referenced structured education in trial tasks. Less than 5% of studies outlined potential caregiver roles in supporting trial attendance, trial adherence, symptom surveillance/management, or study team communication. No trials referenced available supportive care resources for either patients or caregivers.

Overall, despite the demands that EP-CTs place on caregivers and their pivotal role in patient participation, formal trial documents provide limited delineation of caregiver roles and responsibilities. Future work should assess the supplemental role of informal caregiver resources and whether further caregiver consideration can enhance preparedness or care delivery.