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
Authors: Lambert Sylvie D. , Duncan Lindsay R. , Ellis Janet , Robinson John Wellesley , Sears Carly , Culos-Reed Nicole , Matthew Andrew , De Raad Manon , Schaffler Jamie Lynn , Mina Daniel Santa , Saha-Chaudhuri Paramita , McTaggart-Cowan Helen , Peacock Stuart 
Published: March 2021

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).TEMPOis 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 ofTEMPOrevealed high user satisfaction, in addition to having a number of potential benefits for participants. After integrating suggested changes toTEMPO, the proposed pilot study aims to further test the acceptability and feasibility ofTEMPO.

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)TEMPOor (b) usual care. Participants (ngoal = 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 usedTEMPOare 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 onTEMPO’s value for men with prostate cancer and their caregivers to inform a larger trial.

Trial registration

NCT04304196