The feasibility and acceptability of collecting psychosocial outcome measures embedded within a precision medicine trial for childhood cancer

Abstract

Abstract Background Patient‐reported outcomes measures (PROMs) are increasingly being collected within cancer clinical trials, yet limited literature on the feasibility and acceptability of doing so. Methods We collected parent‐proxy and adolescent (≥12 years old) PROMs through a longitudinal, psychosocial sub‐study (‘PRISM‐Impact’) embedded in a precision medicine trial for children with poor prognosis cancer (‘PRISM’). We report on feasibility (response, participation, and attrition rates; follow‐up and responding to elevated distress) and acceptability (parents’ perceived benefit/burden of participation; and impact on decision to participate in PRISM) of PRISM‐Impact. Results Over the reporting period, 462 families were eligible for PRISM‐Impact. Family and adolescent response rates were 53% and 45%, respectively. Parents whose child had relapsed were more likely to participate in PRISM‐Impact than parents whose child had not (p < 0.001). Parent and adolescent attrition rates were 30% and 56% respectively. We conducted 478 calls for intake and to follow‐up on missing questionnaires, and 122 calls to respond to elevated distress. Parents reported wanting to participate in PRISM‐Impact for altruistic reasons and because they valued psychosocial research. Parents reported little‐to‐no burden and some benefit from participating in PRISM‐Impact, with little change in ratings overtime. Most parents felt that participating in PRISM‐Impact did not impact their desire to participate in PRISM (72%), with some feeling more eager to participate (19%). Conclusions PRISM‐Impact response rates were comparable to other psycho‐oncology studies, despite the poor prognosis population. Integration of PROMs within a paediatric oncology trial is acceptable to parents, and may provide a more comprehensive assessment of the impact of trial participation.

Keywords

• acceptability
• clinical trial
• feasibility
• oncology
• outcome measures
• paediatric