Feasibility

The three-tier feasibility decision framework is designed so that even failure to meet the primary threshold generates actionable data for refining the intervention. As a pilot study, MAPLE2 is explicitly not powered to detect statisticall…

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The three-tier feasibility decision framework is designed so that even failure to meet the primary threshold generates actionable data for refining the intervention. As a pilot study, MAPLE2 is explicitly not powered to detect statistically significant differences in clinical effectiveness; it is designed to inform rather than confirm. The vanguard phase screened 719 patients, found 563 eligible, and enrolled 179 patients. The overall platform recruitment rate was 1.37 patients per site-week. Recruitment reached 101 consenting activations and a final feasibility sample of 98 participants. The feasibility study assessed recruitment and engagement rather than intervention effectiveness. The authors concluded that recruitment and interest justified a larger effectiveness trial. Trial withdrawals were low and outcome ascertainment was complete or near-complete. The study planned to recruit 100 participants to assess whether a later effectiveness trial would be possible. Feasibility in MAPLE2 is defined as the proportion of intervention-arm participants who complete all three steps: self-administered GA via app, receipt of personalised recommendations, and confirmed oncologist review.…