Fertility Preservation Discussions And Decisions: Results From a Pilot Randomized Controlled Trial Among Adolescent Males With Cancer.
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BACKGROUND/OBJECTIVES: The Family-centered Adolescent Sperm banking values clarification Tool (FAST) was developed to facilitate sperm banking communication and decision-making pre-cancer treatment. The FAST was tested in a pilot parallel randomized controlled trial (Fertility Preservation Discussions And Decisions: "FP-DAD"-NCT04268004), aiming to (i) assess feasibility/acceptability of FP-DAD; and (ii) examine efficacy regarding banking attempts (yes/no) and decision quality. Differences in decision quality by banking attempt were explored. DESIGN/METHODS: Males (12-25 years, new cancer diagnosis) and caregivers were randomized to standard of care (fertility consult) or FP-DAD (fertility consult + FAST + interventionist-led discussion). One month later, FP-DAD participants completed acceptability surveys. Both arms completed the Brief Subjective Decision Quality measure. Descriptive statistics, chi-square, and independent samples t-tests/mixed-models examined relationships between variables. RESULTS: Acceptability ratings of FP-DAD were high (88%-100%). Recruitment and participation challenges limited the final sample size (21 adolescents and 32 caregivers). Banking attempts (67% in standard of care vs. 82% in FP-DAD) did not differ by arm. While decision quality was not significantly different between groups, effect sizes were medium-large for four of six items for adolescents (d = 0.6 to -0.90) and two of six for caregivers (d = 0.36 to -0.78). Decision quality was significantly higher across several domains among those who banked. CONCLUSIONS: FP-DAD had high acceptability, though feasibility challenges (e.g., time contraints) limited full family participation. Findings showed limited efficacy, but effect sizes suggest this may be due to sample size. Relationships between banking attempts and decision quality emphasize banking benefits. Findings will inform adaptations to the FAST for clinical implementation.