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Background  Prostate cancer predisposes patients and caregivers to a wide range of complex physical and psychosocial challenges, and interventions must incorporate a wide range of self-management strategies to help patients and their caregivers effectively cope with cancer challenges. To palliate this need, our team recently developed and evaluated the initial acceptability of a dyadic, Tailored, wEb-based, psychosocial, and physical activity self-Management PrOgram ( TEMPO ).  TEMPO  is a 10-week, interactive, web-based intervention consisting of five modules designed to help dyads manage their physical and psychosocial needs. It aims to teach dyads new self-management strategies and encourages them to increase their physical activity (PA) levels, mainly through walking and strength-based exercises. Initial acceptability evaluation of  TEMPO  revealed high user satisfaction, in addition to having a number of potential benefits for participants. After integrating suggested changes to  TEMPO , the proposed pilot study aims to further test the acceptability and feasibility of  TEMPO .    Methods  This study is a multicenter, stratified, parallel, two-group, pilot randomized control trial (RCT), where patient–caregiver dyads are randomized (stratified by anxiety level) to receive (a)  TEMPO  or (b) usual care. Participants ( n  goal = 40) are recruited across Canada at participating cancer centers and through self-referral (e.g., online recruitment). Patient inclusion criteria are (a) having received prostate cancer treatment within the past 2 years or scheduled to receive treatment, (b) identified a primary caregiver willing to participate in the study, and (c) has access to the Internet. Eligible caregivers are those identified by the patient as his primary source of support. Dyads complete a baseline questionnaire (T1) and another one 3 months later (T2) assessing various aspects of physical and emotional functioning (e.g., the Medical Outcomes Study (MOS) 12-item Short Form Health Survey (SF-12), the Hospital Anxiety and Depression Scale (HADS), and the Perceived Stress Scale (PSS)), self-management behaviors (e.g., the Health Education Impact Questionnaire (heiQ)), physical activity (the International Physical Activity Questionnaires (IPAQ) and the Multidimensional Self-efficacy for Exercise Scale (MSES)), and dyadic coping (the Dyadic Coping Inventory (DCI)). Dyads that used  TEMPO  are also asked to participate in a semi-structured exit interview exploring their overall experience with the program.    Discussion  This feasibility analysis will begin to develop the knowledge base on  TEMPO ’s value for men with prostate cancer and their caregivers to inform a larger trial.    Trial registration   NCT04304196Supplementary Information  The online version contains supplementary material available at 10.1186/s40814-021-00791-6.

pilot and feasibility studies

A study protocol for a multicenter randomized pilot trial of a dyadic, tailored, web-based, psychosocial, and physical activity self-management program (TEMPO) for men with prostate cancer and their caregivers