A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Toronto
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
>= 18 years of age
Diagnosed with localized or asymptomatic metastatic primary prostate cancer
Not currently undergoing radiation or chemotherapy
Proficient in English
Disqualifiers
Not planning to live in Canada for the next 12 months
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)
Have had a prior fall within the last 12-months
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention
BehavioralDuring 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.
FitBit Only
BehavioralParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Fitbit OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in sedentary behaviour as assessed by activPAL inclinometers
Objectively-assessed sedentary behaviour will be assessed with activPAL inclinometers. The activPALs will be waterproofed and participants will be asked to wear the device in the mid-line of their right thigh for 7 days (24 hours per day). Participants will complete a wear log to identify sleep and non-wear periods. Total daily minutes of sedentary behaviour will be collected from the devices.
Time frame
Baseline, Post-Intervention (12-weeks), 6-month Follow UpSecondary outcomes
1
Change in Self-reported Sedentary Behaviour as assessed by the Longitudinal Aging Study Amsterdam
Self-reported sedentary behaviour will be assessed with the Longitudinal Aging Study Amsterdam (LASA) sedentary behaviour questionnaire. It assesses weekday and weekend sedentary time across 10 domains. The time (hours/minutes) in each domain is summed to determine a total amount of sedentary time.
Time frame
Baseline, Post-Intervention (12-weeks), 6-month Follow Up2
Change in Self-Reported Physical Activity assessed by the Godin Leisure Time Exercise Questionnaire
Self-reported leisure time exercise will be assessed using the Godin Leisure Time Exercise Questionnaire. Participants will self-report the frequency and duration of light, moderate, and vigorous leisure-time exercise. This will be used to calculate a total leisure activity score (higher score indicates higher volumes of activity). The GLTEQ is a valid and reliable measure of exercise among oncology populations.
Time frame
Baseline, Post-Intervention (12-weeks), 6-month Follow Up3
Change in Objectively-assessed Physical Activity as assessed by activPAL inclinometers
Objectively-assessed activity will be assessed with the activPALs. Minutes of activity at a cadence \>100 steps per minute will be considered moderate-to-vigorous physical activity.
Time frame
Baseline, Post-Intervention (12-weeks), 6-month Follow UpOther outcomes
1
Change in Reflective Motivational Processes
Perceived capability and opportunity will be assessed using a modified version of the Rhodes et al., (2006) measures of ability and opportunity. These constructs are measured through six statements (3 addressing ability and 3 addressing opportunity) regarding confidence and control over engaging in light physical activity to replace sedentary behaviour and scored using a 5-point likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Possible scores range from a 3-15 points with higher scores indicating more favorable perceptions of opportunity and ability. Instrumental attitudes and affective judgements will be assessed using a modified version of the Rhodes and Courneya (2003) instrumental and affective attitude measure using a 7-point Likert scale (extremely disagree to extremely agree).
Time frame
Baseline, Post-Intervention (12-weeks), 6-month Follow Up2
Change in Regulatory Motivational Processes
Regulatory processes will be measured through decisional intentions and behavioural regulation (i.e.,planning and monitoring). Decisional intentions will be measured using the following questions "I intend to engage in regular light physical activity \_ times per week during the next 12 weeks", "I intend to break up my sitting time \_ times per weekday during the next 12 weeks." and "I intend to break up my sitting time \_\_\_\_\_\_\_\_ times per weekend day during the next 12 weeks." Behavioural regulation was measured using a modified version of the Sniehotta et al., (2005) planning questionnaire which assesses goal setting, action and coping planning, self-monitoring and scheduling on a 6-item scale. Each item is scored on a 5-point likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 6-30 points with higher scores indicating better self-regulation.
Time frame
Baseline, Post-Intervention (12-weeks), 6-month Follow Up3
Change in Reflexive Motivational Processes
Reflexive processes will be measured through habit formation with the Self-Report Behavioural Automaticity Index from Gardner et al., (2012). Items are scored on a 5-point likert scale (1-strongly disagree to 5-strongly agree) summed to create a total score. Total scores can range from 4-20 points where higher scores indicate a behaviour is more habitual.
Time frame
Baseline, Post-Intervention (12-weeks), 6-month Follow Up4
Change in Disease-Specific Quality of Life as assessed by the Functional Assessment of Cancer Therapy
Disease-specific quality of life will be assessed with the reliable and well-validated Functional Assessment of Cancer Therapy (FACT)-General which consists of physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB), and social well-being (SWB) subscales. The FACT-Fatigue (FACT-Fatigue) scale includes the 27 items from the FACT-General scale plus the 13-item fatigue subscale. On all scales, higher scores indicate better QoL and less symptoms. Scores range from 0-108 and 0-156 for the FACT-General and FACT-Fatigue, respectively. Lower scores indicate a better quality of life.
Time frame
Baseline, Post-Intervention (12-weeks), 6-month Follow UpSponsors and contacts
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University of Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov