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BACKGROUND: The study design and nature of oncology phase 1 clinical trials create a uniquely vulnerable patient population yet little research has been conducted to identify the added burden these trials create for both cancer patients and their caregiver(s). OBJECTIVE: Examining the perceptions and needs of patients and their caregivers participating in phase 1 oncology clinical trials, the investigators tested the hypothesis that the caregiver will exhibit a higher level of burden and/or distress than the patient. METHOD: A mixed-methods exploratory process utilizing patient and caregiver interviews and quality-of-life questionnaires was used to assess the psychosocial burdens associated with oncology clinical trial participation. A qualitative and quantitative analysis of the responses were 8 performed. RESULT: Both patients and caregivers reported similar themes identifying the burdens and benefits related to phase 1 clinical trial participation. However, the caregivers' expressed burden exceeded that of the patients' validating the study's hypothesis. CONCLUSION: The need for ongoing additional support services for not only the patient but also the caregiver was identified.
Rezash et al. (Tue,) studied this question.