NCT05214937Recruiting
A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors
A Distance-based, Randomized Controlled Trial for Reducing Sedentary Behaviour Among Prostate Cancer Survivors
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 15 Dec 2021
- Start date
- 15 Feb 2022
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- University of Toronto
- Diseases
- Prostate cancer
- NCT number
- NCT05214937
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 15 Feb 2022 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have had a prior fall within the last 12-months
Other illness
- A medical condition that prohibits walking (e.g., severe knee or hip arthritis)
- Presence of other primary or recurrent invasive cancer (i.e., other than non-melanoma skin cancer)
Other
- Not planning to live in Canada for the next 12 months
- Use a gait aid device
Who the study is looking for
- \>= 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.