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RECRUITING
NCT05214937
NA

A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

Sponsor: University of Toronto

View on ClinicalTrials.gov

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.

Official title: A Distance-based, Randomized Controlled Trial for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-02-15

Completion Date

2026-12-01

Last Updated

2024-12-04

Healthy Volunteers

No

Interventions

BEHAVIORAL

Intervention

During the first two weeks (baseline), participants will be asked to maintain their regular movement routine to set a baseline daily average step count. Phases I-III will involve self-regulatory strategies (e.g., action planning), address reducing/interrupting sedentary time, and step counts. Participants will be encouraged to increase their steps by 1000 steps/day from the baseline phase during each subsequent phase (i.e., 3000 steps above baseline by Phase III). Phases IV-V will be a maintenance phase through which participants will be encouraged to maintain 3000 steps per day above baseline. The sessions will be grounded within the Multi-Process Action Control Framework and address perceived capability/opportunity and instrumental/affective attitudes. The 1-on-1 sessions will focus on regulation (action \& coping planning, social support, goal setting) and reflexive processing (self-regulation, habit). The final one on one session will be a booster session to revisit previous topics.

BEHAVIORAL

FitBit Only

Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living. They will receive a FitBit orientation session with a movement specialist prior to the 12-week control period.

Locations (1)

University of Toronto

Toronto, Ontario, Canada