Family caregivers support their patient's decision to participate in a phase 1 clinical trial: Weighing the pros and cons, bearing the costs

Abstract

Objectives When patients with advanced cancer pursue phase 1 clinical trials, family caregivers are impacted as they adopt new roles and responsibilities in time‐pressured, uncertain circumstances. This study explored the nature of the caregivers' participation in patients' decision to pursue phase 1 clinical trials and the early impact of the decision on the caregiver. Methods Semi‐structured interviews were conducted with 19 family caregivers of advanced cancer patients who had agreed to participate in phase 1 clinical trials. They were coded for information about the caregiver's relationship with the patient, typical style of decision‐making together, understanding of the patient's prognosis and trial, contributions to decision‐making and the initial impacts of the trial on the caregiver. Codes illuminating the research questions were grouped into categories and themes, compared across transcripts and examined against the literature. Results Caregivers unequivocally supported the patients' decision to pursue the phase 1 trial as they hoped that the patient would derive medical benefit from the trial. They withheld their opinions and fears about the trial from the patients to support patient autonomy during the decision‐making process. The patient's decision to participate increased the caregivers' burdens and deprived them of time spent on pleasurable activities at end of life. Conclusions Respecting the patients' personal autonomy, caregivers supported the trial, despite the complex caregiving required. As the success of phase 1 trials relies on caregiver involvement, it is imperative that healthcare professionals be sensitized to the support needs of these caregivers.

Rhetoric of research: a call for renaming the clinical research partnership

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A pilot randomized study of a telephone-based cognitive-behavioral stress-management intervention to reduce distress in phase 1 oncology trial caregivers

“…Caregivers of phase 1 oncology trial patients are a distressed population (Kessler et al 2014;Kogan et al 2022;Rezash et al 2019). Caregiver distress stems from the multiple stressors related to the phase 1 oncology trial experience, as these trials are first in human safety studies of a new pharmacological agent (Weber et al 2015).…”

“…Thus, caregivers of phase 1 oncology trial patients are at risk for negative outcomes (low social support, mood, increased morbidity, and mortality) due to the myriad of physical, emotional, and mental stressors associated with the trial and demands of caregiving (Bevans and Sternberg 2012;Northouse et al 2012). However, research to date on this caregiver population is cross-sectional (Kessler et al 2014;Rezash et al 2019) or exploratory (Kogan et al 2022), and there are no longitudinal evidenced-based interventions focused on addressing the specific needs of this population.…”