Feasibility of a Habit-Based Intervention to Reduce Sedentary Behaviour in Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Toronto
About this trial
Cancer and its treatments are associated with long-term side effects including lowered physical strength and quality of life. Decreasing sedentary behaviour improves health outcomes in cancer survivors. Habit-based programs aimed at lowering sedentary behaviour have been successful in decreasing sedentary behaviour in other populations. However, limited clinical trials aimed at lowering sedentary behaviour have recruited cancer survivors, and none are exclusively based on Habit Theory.
The primary goal of this clinical trial is to test the feasibility of an 8-week, habit-based program to lower sedentary behaviour in cancer survivors. Sedentary behaviour refers to low-energy activities performed during waking hours in a seated, reclined or laid down position. Secondarily, this clinical trial aims to examine changes in sedentary behaviour, physical strength, habit, and quality of life.
Enrolled participants will be assigned to a sedentary behaviour or active control group. The sedentary behaviour group will receive 8 weekly sheets consisting of tips recommending to lower sedentary behaviour. Tips will be individualized to participants' lifestyles, and will consider their cancer-specific and other physical limitations. Participants in the sedentary behaviour group will also meet with the researcher once a week for a check-in session for more individualized tips and progressions. The active control group will receive the Canadian 24-hour Movement Guidelines, and a handout highlighting the benefits of lowering sedentary behaviour. Both groups will be provided with wearable activity monitors (Fitbits).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
have been diagnosed with localized or asymptomatic metastatic cancer of any type
completed primary cancer treatment
self-report being sedentary for more than or equal to 8 hours per day
Disqualifiers
presence of other primary or recurrent invasive cancer
having experienced a fall in the last 12 months
not residing in Canada
participating in other behaviour change interventions
Trial design
Design model
Parallel
Treatments tested in this trial
Sedentary Behaviour Intervention
BehavioralThe sedentary behaviour intervention will consist of weekly tick-sheets, one weekly check-in session, and a Fitbit for physical inactivity reminders over 8 weeks. The weekly tick-sheets will consist of tips recommending to lower sedentary behaviour by enacting actions in the presence of cues. Progressions, illustrations and steps to perform these actions will be provided as an attachment with the tick-sheets. An example of a tip is "During TV/online video ad breaks or when you finish watching one episode of a show or online video, climb up and down a staircase to reduce cancer-related fatigue associated with prolonged sitting". Tips will be individualized to participants' lifestyles, and will consider their cancer-specific and other physical limitations. Participants in the sedentary behaviour group will also meet with the researcher once a week for a check-in session for more individualized tips and progressions.
Active Control Group
Other interventionThe active control group will receive the Canadian 24-hour Movement Guidelines, and a handout highlighting the benefits of reducing sedentary behaviour. They will also receive Fitbits, with the hourly inactivity reminders turned off.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Sedentary Behaviour Intervention GroupExperimental treatment 1 intervention
Group B: Active Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Enrollment
Participant enrollment rate will be a measure of feasibility. Enrollment will be calculated by measuring the number of participants who enrolled in the intervention, divided by the number of participants who were assessed for eligibility.
Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).2
Adherence
Adherence is another measure of feasibility. Two types of adherence will be measured: check-in session adherence and tip adherence. Check-in session adherence will be calculated by assessing the number of check-in sessions attended divided by the total number of check-in sessions that took place (i.e. 8 sessions). Tip adherence will be calculated by the number of days that the daily tip goal of 2-4 tips was met, divided by 56 (7 days per week for 8 weeks).
Time frame
From baseline (pre-intervention) to post-intervention (8 weeks).3
Attrition
Attrition will be a measure of feasibility. Attrition will be measured by calculating the number of participants who did not complete the intervention, divided by the number of participants who were randomized.
Time frame
Assessed from baseline (pre-intervention) to post-intervention (8 weeks).4
Adverse Events
Adverse events will be a measure of feasibility. This will be assessed as an unexpected and severe medical problem or injury (e.g., cardiac-related events, musculoskeletal injury or pain, falls) that occurs due to the intervention.
Time frame
From baseline (pre-intervention) to post-intervention (8 weeks).Secondary outcomes
1
Objective Sedentary Behaviour
Objective sedentary behaviour will be measured using inclinometers (i.e. the ActivPAL) pre- and post-intervention. The inclinometer records the amount of time spent lying, sitting, standing, in upright position, cycling, in seated transport, total sedentary time, and sit-to-stand transitions. Participants will be mailed the inclinometers and will be provided instructions through videoconferencing.
Time frame
Change from baseline (pre-intervention) to post-intervention (8 weeks).2
Self-Reported Sedentary Behaviour
Self-reported sedentary behaviour will be measured using the AusDiab3 Sedentary Behaviour Questionnaire. This questionnaire measures the amount of time, in minutes and hours, spent seated, reclined or laying down while working, using transport, watching TV, as well as playing computer, internet, and electronic games, in the past week on weekdays and weekends. The choices for this questionnaire are none, 15 minutes or less, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, or 6 hours or more.
Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).3
Habit
Habit will be assessed using the brief Self-Report Behavioural Automaticity Index. This is a 4-item measure that assesses the automaticity of specific behaviours (i.e. actions in the tick-sheets to reduce sedentary behaviour).
Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).4
Physical Function
Physical function will be measured at baseline and follow-up using the remotely-delivered 30-second sit-to-stand and 6-minute walk tests. The purpose of the 30-second sit-to-stand test is to measure participants' lower body strength and endurance by measuring the number of full chair stands with arms folded at the chest completed in 30-seconds. The 6-minute walk test assesses functional walking capacity by the distance walked in 6 minutes without running or jogging. A qualified exercise professional will administer these tests.
Time frame
Change from baseline (pre- intervention) to post-intervention (8 weeks).Sponsors and contacts
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Source ClinicalTrials.gov