Abstract
BackgroundProstate 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.MethodsThis 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.DiscussionThis 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 registrationNCT04304196
Highlights
Prostate cancer management presents patients and their caregivers with a myriad of complex physical and psychosocial challenges [1,2,3]
The pilot procedures will be feasible if (a) eight dyads/month are recruited across sites, (b) refusal rate does not exceed 45%, (c) missing data are less than 10% [29], and (d) protocol infringements are amenable to change
Caregivers of men with prostate cancer remain a vulnerable group throughout the illness trajectory, as they often experience more anxiety and needs than patients [3, 6], but have access to fewer services [11]
Summary
Design The proposed study is a multicenter, stratified, 1:1, parallel, two-group pilot randomized control trial, whereby patient–caregiver dyads are randomized to receive (a) TEMPO or (b) usual care. Studies by our team using item response theory [65, 66] have supported the ability of the HADS to discriminate between anxiety and depression among patients with cancer and their caregivers. Health Education Impact Questionnaire (heiQ) [71] The heiQ (Version 3.0) is a 40-item measurement system examining the effects of health education programs on individuals’ self-management skills for coping with a chronic condition [71] It consists of eight different subscales: (a) positive and active engagement in life, (b) skill and technique acquisition, (c) constructive attitude and approaches, (d) self-monitoring and insight, (e) health services navigation, (f) social integration and support, (g) health-directed activity, and (h) emotional distress [71]. Any protocol deviations will be recorded and depending on the nature, will be submitted to the ethics committee as an amendment
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