Conducting a Randomized Clinical Trial of an Psychological Intervention for Parents/Caregivers of Children with Cancer Shortly after Diagnosis

ObjectiveTo report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer.MethodEighty-one families were randomly assigned following collection of baseline data to Intervention or Treatment as Usual (TAU). Recruitment and retention rates and progression through the protocol were tracked. Measures of state anxiety and posttraumatic stress symptoms served as outcomes.ResultsDifficulties enrolling participants included a high percentage of newly diagnosed families failing to meet inclusion criteria (40) and an unexpectedly low participation rate (23). However, movement through the protocol was generally completed in a timely manner and those completing the intervention provided positive feedback. Outcome data showed no significant differences between the arms of the RCT.ConclusionsThere are many challenges inherent in conducting a RCT shortly after cancer diagnosis. Consideration of alternative research designs and optimal timing for interventions are essential next steps.