An interventional study of Sedentary Behaviour Intervention and Active Control Group in Cancer and Sedentary Behaviour, sponsored by University of Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University of Toronto · Not applicable, Interventional, and Supportive care
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).
Cancer and its treatments are associated with late and long-term side effects such as reduced quality of life (QoL) and physical function. Reducing sedentary behaviour (SED), any waking behaviour characterized by a low-energy expenditure performed while seated, reclined or lying down, has been shown to improve health outcomes in cancer survivors. Habit is a cognitive process in which a cue triggers a specific behaviour, learned through repetition of the behaviour every time the cue is encountered. By prompting sedentary breaks through everyday cues, SED may decrease in cancer survivors that may be sustained long-term. Current habit-based sedentary behaviour interventions in other populations are limited as they have only used self-report measures, did not recruit control groups, and/or were not exclusively grounded in Habit Theory. Additionally, remotely-delivered interventions may be an effective option to decrease sedentary behaviour in cancer survivors, while expanding reach and improving accessibility by overcoming barriers to participation in traditional in-person programs. To address the current gaps in the literature, research is needed to assess the feasibility of a remotely-delivered SED program for physical function and quality of life in cancer survivors. Therefore, the primary objective of this study is to examine the feasibility (adherence, safety, attrition, and participant satisfaction) of an 8-week, remotely-delivered, habit-based intervention to reduce SED in cancer survivors compared to an active control group (movement guidelines and sedentary behaviour handout). Feasibility indicators are: (1) check-in session adherence rate ≥70%, (2) tip adherence ≥70% (based on goal of following 2-4 tips per day), attrition rate \< 30%, and no intervention-related adverse events. Secondary objectives include examining changes in (1) physical function, (2) general health-related and cancer-specific QoL, (3) habit, and (4) objective and device-based sedentary behaviour of cancer survivors. The trial findings may be used to inform larger randomized controlled trials to reduce SED in cancer survivors, and may be a cost-effective and accessible option for cancer survivors to optimize their health.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Toronto is the lead sponsor of 403 studies on the registry; 54 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The 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.
Behavioral: Sedentary Behaviour Intervention
The 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.
Other: Active Control Group
The 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.
The 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.
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).
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).
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).
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).
Participant Satisfaction
A participant satisfaction survey will be administered following the 8-week intervention to assess the acceptability of the intervention by using researcher-generated statements (e.g., "I found the sedentary behaviour reduction intervention rewarding"). The survey will assess the burden of the program and the participant's feedback regarding the sedentary behaviour intervention and overall study experience. Likert scales ranging from 1 (not at all) to 5 (very much) will be used. The active control group will complete a satisfaction survey which will include statements relevant to the active control arm.
Time frame: Post-intervention (8 weeks).
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).
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).
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).
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).
Cancer-Specific Quality of Life
Cancer-specific quality of life will be measured using the FACT-G. This is a 27-item questionnaire that assesses four domains of health-related quality of life in the past 7 days: physical, social, emotional, and functional well-being . Participants will be asked to rate each statement on a 5-point Likert scale (0= "not at all", 4= "very much") based on how much they relate to the statement.
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
General-Health-Related Quality of Life
General health-related quality of life will be measured using the Short Form-12 questionnaire. This questionnaire consists of 12 items that measure 8 physical and mental health-related domains: general health, physical functioning, role physical, body pain, vitality, social functioning, role emotional, and mental health.
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Self-Reported Exercise
Self-reported exercise will be measured using the modified Godin Leisure-Time Exercise Questionnaire. Participants will report the number of times per week and minutes per session that they engage in light, moderate, and vigorous leisure-time exercise, and resistance exercise. Total weekly minutes of moderate-to-vigorous physical activity will be calculated as the sum of the number of moderate exercise minutes per week, plus twice the number of vigorous exercise minutes per week.
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Clinical Demographics
Clinical variables include: cancer type, date of diagnosis, cancer stage, cancer spread, cancer stage, cancer treatment(s) received, current treatment status, previous recurrence, other cancer diagnoses, general health status, comorbidities, smoking history, and alcohol consumption history.
Time frame: Baseline (pre-intervention)
Demographic Variables
Demographic variables collected will include age (in years), sex (options are male, female, other, and prefer not to say), gender (options are agender, bigender/multigender, gender fluid, genderqueer, man, nonbinary, transgender, two-spirit, woman, other, and prefer not to say), marital status (options are single, married, common-law, separated, widowed, and divorced), highest level of education (options are some high school, completed high school, some university/college, completed university/college, some graduate school, and completed graduate school), current employment status (options are disability, retired, part-time, homemaker, full-time, and unemployed), ethnicity (options are Black, East Asian, Middle Eastern, Arab or West Asian, Latin American, South Asian, Southeast Asian, White, and other in which they would be asked to specify) as well as height (in feet and inches) and weight (in pounds) to calculate body mass index.
Time frame: Baseline (pre-intervention)
Fatigue
Fatigue will be assessed at baseline and follow-up using the Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-Fatigue). The FACIT-Fatigue is a 13-item measure which assesses self-reported fatigue and its effect on daily activities and function. Participants will be asked to rate 13 items related to their fatigue in the previous 7 days on a 5-point Likert scale (0="not at all" or "never" and 4= "very much" or "several times/day) in which higher scores indicate higher quality of life.
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Plan to share: No
Started Dec 2025 (actual). Primary completion is estimated for Sep 2026, 9 months after the start.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 9 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
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