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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• \>= 18 years of age

• Diagnosed with localized or asymptomatic metastatic primary prostate cancer

• Not currently undergoing radiation or chemotherapy

• Proficient in English

• Not physically active (self report \<150 minutes of moderate-to-vigorous physical activity per week)

• Self-report \>8 hours of daily sedentary behaviour

• In the contemplation or preparation stage for motivational readiness to change as determined by the Stages of Change Questionnaire

• Access to a smartphone, tablet, or computer

• No cardiac contraindications (e.g., unstable angina, arrhythmia, heart failure, aortic stenosis)

• Medical clearance from a primary health care provider (if necessary)

• Currently residing in Canada

Locations
Other Locations
Canada
University of Toronto
RECRUITING
Toronto
Contact Information
Primary
Linda Trinh, PhD
linda.trinh@utoronto.ca
416-946-3624
Time Frame
Start Date: 2022-02-15
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 120
Treatments
Experimental: Intervention
Participants will be provided with a FitBit Inspire 2 and assigned a movement specialist. They will be asked to monitor their daily steps over the 12-week intervention period. Participants will attend 6 remotely-delivered behaviour change sessions (4 one-on-one sessions with their movement specialist, 2 group-based webinars). Sessions will be delivered bi-weekly and last \~30 minutes.
Active_comparator: Fitbit Only
Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living (e.g., 24-hour movement guidelines).
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: University of Toronto

This content was sourced from clinicaltrials.gov