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

Objective To report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer. Method Eighty-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. Results Difficulties 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. Conclusions There 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. Key words anxiety; caregivers; intervention; parents; pediatric cancer; posttraumatic stress; randomized clinical trial. Recognizing that a diagnosis of childhood cancer causes distress, national organizations recommend that psychoso-cial services be provided to families at diagnosis (American Academy of Pediatrics, 1997; Noll & Kazak, 2004). Unfortunately, there are few published studies on interven-tions around the time of diagnosis and recognition that the psychosocial needs of families are inadequately addressed (Institute of Medicine, 2007). In this article we briefly discuss the nature of parental distress at diagnosis and the evidence regarding psychosocial interventions for families of children newly diagnosed with cancer. We then focus on the acceptability, feasibility, and outcomes from a randomized clinical trial (RCT) of Surviving Cance