ReviewSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2026
Considering the caregiver in early-phase clinical trials: a review of trial protocols and consent forms.
Review in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformal 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.
methodsWe 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.
resultsOverall, 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.
conclusionOverall, 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.
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.