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

Abstract

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

Home-based self-management multimodal cancer interventions & cardiotoxicity: a scoping review

“…However, there were no other significant differences observed ‘TEMPO’ Prostate Cancer (couples-only) Web-based 10 weeks Self-Management, Communication, Lifestyle/ Behavioural Change, Psychoeducation, Symptom Management 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 Study Protocol (Lambert et al . [ 55 ] , Canada) N/A N/A Patient Information Leaflet Abdominal Cancer (Colorectal/ Ovarian) Paper-based 1–2 weeks prior to surgery Physical Activity, Nutrition, Relaxation, Smoking Cessation, Alcohol Cessation Prehabilitation in cancer care: patients’ ability to prepare for major abdominal surgery Original Article (Beck et al . [ 20 ] , Denmark) Qualitative interviews and adherence records The authors concluded from the combined adherence and interview data that the leaflet functioned as a tool to motivate and support patients’ prehabilitation-related actions WEST Breast Cancer Web-based 24 weeks Physical Activity, Nutrition, Telephone Counselling Effects of a web-based expert support self-management program (WEST) for women with breast cancer: A randomized controlled trial RCT (Kim & Kim [ 56 ] , Korea) HS-SES, Physical measures (e.g., height, weight) At 24 weeks, the intervention group demonstrated greater decreases in body fat/percentage and waist circumference but no differences were found for perceived self-efficacy WSEDI Breast Cancer Web-based 12 weeks Physical Activity, Nutrition, Self-Management Skills A Web-based self-management exercise and diet intervention for breast cancer survivors: Pilot randomized controlled trial ...…”

A systematic review and meta‐analysis of the association between anxiety symptoms and coping in family carers of dependent people aged 18 and over

“…Therefore, use of problem‐focused coping, theoretically considered to be protective of anxiety (Lambert et al., 2021), may be more or less effective depending on the cause of dependency of care and condition (Wartella et al., 2009). Despite being informative however, our results should be interpreted with caution given that the number of studies included in our meta‐analyses comparing different caregiving groups was generally small.…”

Feasibility, Acceptability, and Clinical Significance of a Dyadic, Web-Based, Psychosocial and Physical Activity Self-Management Program (TEMPO) Tailored to the Needs of Men with Prostate Cancer and Their Caregivers: A Multi-Center Randomized Pilot Trial

“…The next step in evaluating TEMPO is a pilot study whereby a priori criteria have been established (see Table 2 ) to determine TEMPO ’s feasibility and acceptability. The objectives of this pilot randomized controlled trial (RCT) were to (a) examine its feasibility, which includes rates of recruitment and refusal, questionnaire completion (including questionnaires for future cost-utility analysis), and protocol infringement; (b) examine the acceptability of TEMPO as evidenced by attrition, adherence, satisfaction, and perceived usefulness; and (c) estimate the clinical significance on anxiety and quality of life (primary outcomes, Supplementary Material S2 ), as well as depression, self-management skills, physical activity, self-efficacy, and appraisal (secondary outcomes) [ 39 ].…”