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