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. 2021 Mar 20;7(1):78.
doi: 10.1186/s40814-021-00791-6.

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

Sylvie D Lambert  1   2 , Lindsay R Duncan  3 , Janet Ellis  4   5 , John Wellesley Robinson  6   7 , Carly Sears  8 , Nicole Culos-Reed  9   10   11 , Andrew Matthew  12   4   13 , Manon De Raad  14 , Jamie Lynn Schaffler  14 , Daniel Santa Mina  15   16 , Paramita Saha-Chaudhuri  17 , Helen McTaggart-Cowan  18   19 , Stuart Peacock  18   19   20
Affiliations

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

Sylvie D Lambert et al. Pilot Feasibility Stud. .

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.

Keywords: Cancer rehabilitation; Cancer survivorship; Caregivers; Dyadic intervention; Prostate cancer; Self-management.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
TEMPO landing page. This figure illustrates the content and layout of the TEMPO platform. Available from https://tempo.truenth.ca
Fig. 2
Fig. 2
TEMPO Health Library landing page. This figure illustrates the layout of the TEMPO Health Library including the eight categories of factsheets
See this image and copyright information in PMC

References

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    1. Lambert SD, Harrison JD, Smith E, Bonevski B, Carey M, Lawsin C, Paul C, Girgis A. The unmet needs of partners and caregivers of adults diagnosed with cancer: a systematic review. BMJ supportive & palliative care. 2012;2(3):224–230. doi: 10.1136/bmjspcare-2012-000226. - DOI - PubMed
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    1. Lambert S, Girgis A, Descallar J, Levesque JV, Jones B. Trajectories of mental and physical functioning among spouse caregivers of cancer survivors over the first five years following the diagnosis. Patient education and counseling. 2017;100(6):1213–1221. doi: 10.1016/j.pec.2016.12.031. - DOI - PubMed

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