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Randomized Controlled Trial
. 2022 Feb 1;29(2):785-804.
doi: 10.3390/curroncol29020067.

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

Sylvie D Lambert  1   2 , Lindsay R Duncan  3 , S Nicole Culos-Reed  4   5 , Laura Hallward  3 , Celestia S Higano  6 , Ekaterina Loban  1   7 , Anne Katz  8 , Manon De Raad  1 , Janet Ellis  9 , Melissa B Korman  10 , Carly Sears  11 , Cindy Ibberson  1 , Lauren Walker  12 , Eric Belzile  1 , Paramita Saha-Chaudhuri  13 , Helen McTaggart-Cowan  14 , Stuart Peacock  14
Affiliations
Randomized Controlled Trial

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

Sylvie D Lambert et al. Curr Oncol. .

Abstract

Background: Prostate cancer is the most common cancer diagnosis among men. Family caregivers (often female spouses) play a key role in ensuring patients' needs are met, frequently assuming their role with no formal training, which can contribute to a high burden. The purpose of this study was to pilot TEMPO-the first dyadic, Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram for men with prostate cancer and their caregivers.

Methods: 49 men with prostate cancer and their caregivers were randomized to TEMPO or usual care. Baseline and follow-up questionnaires were completed to assess feasibility, acceptability, and clinical significance. A priori benchmarks for these outcomes were set. Thirteen exit interviews were conducted to further explore acceptability.

Results: Feasibility benchmarks were met with the exception for recruitment with on average 6.1 dyads recruited/month (benchmark: 8 dyads/month). Benchmarks of acceptability focused on attrition (<25%) and system usability, which were met. Using the strict criteria for adherence of 100% of the module viewed and participants spending at least 15 min on the module, 45% of participants were adherent. The clinical significance on anxiety and quality of life was supported for caregivers, and mostly supported for the men with prostate cancer.

Conclusion: This pilot trial was successful, with minor modifications needed prior to a large trial.

Keywords: behavior change; caregivers; dyadic interventions; dyads; e-Health interventions; physical activity; pilot study; prostate cancer; psychosocial needs; self-management.

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Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design, execution, interpretation, or writing of the study.

Figures

Figure 1
Figure 1
Flow diagram of recruitment and enrollment in TEMPO.
See this image and copyright information in PMC

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