RESUMEN
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: NCT04304196.
RESUMEN
Caregivers of men with prostate cancer report high burden, and there is a need to develop cost-effective programs to support them in their roles. This study reports on the acceptability of a dyadic, Tailored, wEb-based, psychosocial and physical activity (PA) self-Management PrOgram called TEMPO. TEMPO was accessed by a convenience sample of 19 men with prostate cancer and their caregivers (n = 18), as well as six health care professionals (HCPs). User feedback was gathered via semi-structured qualitative interviews. Data were analyzed using thematic analysis. Most dyads were satisfied with TEMPO, particularly with the dyadic feature of TEMPO, the focus on goal setting to integrate self-management, and the extensive health library. The patients and caregivers motivated each other as they worked through TEMPO. Most goals to achieve during TEMPO pertained to increasing PA, followed by learning physical symptom management. One unanticipated benefit of TEMPO for the dyads was improved communication. HCPs agreed that TEMPO was a novel approach to online cancer self-management and they echoed the benefits reported by dyads. Key suggestions for improving TEMPO were to reduce repetition, tailor content, add more exercise ideas, and have more printing options. This study provides a strong foundation on which to plan a larger trial.