RecruitingNot ApplicableNCT05214937

A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

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


Sponsor

University of Toronto

Enrollment

120 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a smartphone-based program to help prostate cancer survivors sit less and move more throughout the day. Spending too much time sitting (sedentary behavior) may affect cancer outcomes and quality of life, and this study explores whether a tailored digital coaching intervention can help. **You may be eligible if...** - You are 18 years old or older and live in Canada - You have been diagnosed with localized prostate cancer or asymptomatic metastatic prostate cancer - You are not currently receiving radiation or chemotherapy - You currently sit for more than 8 hours per day - You exercise less than 150 minutes per week - You are not yet regularly active but are thinking about becoming more active - You have access to a smartphone, tablet, or computer **You may NOT be eligible if...** - You have a condition that prevents you from walking (such as severe arthritis) - You have had a fall in the last 12 months or use a walking aid - You have another active cancer besides non-melanoma skin cancer - You are not planning to stay in Canada for the next 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIntervention

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.

BEHAVIORALFitBit 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

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NCT05214937


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