Clinical Trial

A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

Recruiting
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Record status
This record was last updated December 4, 2024 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This randomized controlled trial (RCT) will aim to examine the effect of a 12-week behavioural intervention on changing the sedentary behaviours (SB) of prostate cancer survivors (PCS) compared to a control group (FitBit-only group). PCS in the intervention group will receive a FitBit and 6 behavioural support sessions with a movement specialist guided by behavioural theory (i.e., the Multi-Process Action Control \[M-PAC\]). The FitBit-only group will only receive a FitBit and access to public health resources on physical activity (PA). The primary purpose of this study is to determine the efficacy of the intervention on changing SB of PCS immediately following the 12-week intervention and 6-months later. It is hypothesized that that the intervention will decrease their SB compared to the FitBit-only control condition at both timepoints. This trial will also examine the effect of the intervention on changing PA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function, quality of life, fatigue, disability and mental health compared to the active control condition.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-01-17; most recent amendment 2024-12-03.
Status change: Not Yet Recruiting → Recruiting 2022-04-15
Trial Details
NCT Number NCT05214937
Lead Sponsor University of Toronto
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Sedentary Behavior, Cancer of Prostate
Enrollment 120 participants
Start Date 2022-02-15
Primary Completion 2025-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-04