%0 Journal Article
%T The feasibility and acceptability of collecting psychosocial outcome measures embedded within a precision medicine trial for childhood cancer.
%A Robertson EG
%A Hetherington K
%A Daly R
%A Donoghoe MW
%A Handelsman N
%A Ziegler DS
%A Wakefield CE
%J Cancer Med
%V 13
%N 12
%D 2024 Jun
%M 38898768
%F 4.711
%R 10.1002/cam4.7339
%X <B>BACKGROUND: </B>Patient-reported outcomes measures (PROMs) are increasingly being collected within cancer clinical trials, yet limited literature on the feasibility and acceptability of doing so.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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%).<BR><B>CONCLUSIONS: </B>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.