Considering the caregiver in early-phase clinical trials.

Abstract

e13899 Background: Patients enrolled in early-phase clinical trials (EP-CTs) often rely on family and friends for caregiving support. In these settings, informal caregivers take on significant challenges, including complex care tasks, demanding appointment schedules, and substantial financial burdens. Despite this, small qualitative studies suggest EP-CT caregivers receive minimal guidance regarding trial structure and caregiving responsibilities. To date, no studies have systematically assessed how EP-CTs may consider and orient caregivers around their involvement. Thus, this study sought to characterize how caregivers are addressed in key study documents, including informed consent forms and trial protocols. Methods: We identified all adult EP-CTs registered on clinicaltrials.gov from 1990–2025 with available informed consent and study protocol documents. Subsequently, three trained research assistants manually reviewed all forms. Using a structured codebook, they recorded whether caregivers were mentioned. If so, they searched for references related to the following categories: 1) involvement in informed consent discussions, 2) education on trial tasks (i.e. medication administration), 3) attendance at trial visits, 4) adherence monitoring, 5) symptom surveillance or management, 6) communication with the study team, and 7) supportive care resources. Descriptive statistics were used to summarize all data. Results: A total of 145 EP-CT trials (66 phase I, 79 phase I/II) met eligibility criteria and were included in the analysis. The median trial size was 27 participants, and included cancer types varied (66.9% solid only, 26.2% hematologic only, 6.9% mixed). Overall, 78.6% of studies referenced caregivers. Most trials suggested or encouraged caregiver involvement in informed consent discussions (77.2%), though only 6.2% explicitly committed to discussing study details with caregivers. A minority offered structured education on trial responsibilities (9.0%), and fewer addressed expectations related to attendance at trial visits, adherence monitoring, symptom surveillance or management, or communication with the study team (< 5.0%). No trials mentioned available supportive care resources for caregivers. Conclusions: Despite the demands that EP-CTs place on caregivers and their pivotal role in patient participation, caregivers receive limited mention in key study documents. Efforts to incorporate language addressing caregiver involvement in EP-CTs may enhance caregiver inclusion and preparedness, while further optimizing patient care during trial participation.