A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers

"Stage 1 interventions (weeks 1-12): TEMPO.~After 12 weeks, the benefit of the initial assignment will be assessed. Benefit is defined as a score \< 3 on the ESAS-r anxiety item (range 0-10) or a decrease \>= 2 points from eligibility screening. If both dyad members had anxiety symptoms at recruitment, both must meet the benefit criterion. If one member no longer meets the criterion, the dyad is considered did not benefit.~Stage 2 interventions (weeks 13-25): TEMPO or lay guidance.~1. TEMPO responders will continue with TEMPO. Dyads who did not benefit will be re-randomized to:~ 1. Stepping up to lay guidance (8 x 20-minute calls via phone or Teams). Guides will receive TEMPO training and conduct semi-structured exit interviews.~ 2. More time with TEMPO for dyads who benefited from it.~2. Non-responders to usual care in Stage 1 will be stepped up to TEMPO."

"Stage 1 interventions (week 1-12): Patients will receive usual care throughout the study. Dyads in this group will not receive any information resources from the research team but will have access to all of those available at their participating center (sites will be asked to provide a description of usual care practices).~Stage 2 interventions (week 13-25): Dyads not responding to active monitoring will be stepped up to TEMPO; responders to active monitoring will only be invited to complete the follow-up measures."