Health-related quality of life and enrollment in Phase 1 trials in children with incurable cancer

OBJECTIVES: To investigate health-related quality of life (HRQOL) in children eligible for Phase 1 trials and the reasons why families consider participating in these trials. METHODS: Individual, semistructured interviews were conducted with parents (seven mothers, two fathers) and three children, after a child was invited to participate in a clinical trial. Information regarding disease and treatment progression, daily life, and decision making about experimental treatments was elicited. Interviews were recorded, transcribed, and coded for themes. RESULTS: HRQOL themes were grouped into four main domains: physical, psychological, social, and spiritual. Minimal physical restrictions, maintaining normalcy and control, information sharing, and having hope for life seemed to be critical HRQOL components. Hope for a cure and prolonging the child's life were the main reasons for enrolling in Phase 1 trials. CONCLUSIONS: Normalcy and control are key end-of-life HRQOL components, and hope for life is a main reason for participating in Phase 1 trials.