How did partners experience cancer patients' participation in a phase I study? An observational study after a patient's death.

Objective: It can be assumed that patients' participation in a phase I study will have an important impact on their partners' life. However, evaluation of partners' experiences while patients are undergoing experimental treatment and of their well-being after the patient's death is lacking. We aimed to explore partners' experience of patients' participation in phase I studies and to investigate their well-being after a patient's death.

Method: This was an observational study conducted after the patient's death. Partners of deceased patients who had participated in a phase I study completed a questionnaire designed by us for experience evaluation and the Beck Depression Inventory for Primary Care, the Hospital Anxiety and Depression Scale, the Inventory of Traumatic Grief, and the RAND-36 Health Survey.

Results: The median age of the 58 participating partners was 58 years (range: 51-65), and 67% was female. Partners reported negative effects on patients' quality of life, but only 5% of partners regretted patients' participation. Approximately two years after the patients' death, 19% of partners scored for depression, 36% for psychological distress, and 46% for complicated grief, and partners generally scored significantly lower on social and mental functioning compared to normative comparators.

Significance Of Results: Although partners reported negative consequences on patients' quality of life, most did not regret patients' participation in the phase I studies. Prevalence of depression, psychological distress, and complicated grief seemed important problems after a patient's death, and these must be considered when shaping further support for partners of patients participating in phase I trials.