CancerNCT07694479
Feasibility of a Habit-Based Intervention to Reduce Sedentary Behaviour in Cancer Survivors
A study testing Sedentary Behaviour Intervention in people with Cancer and Sedentary Behaviour, run by University of Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Sedentary Behaviour
- What is being tested?
- Sedentary Behaviour Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 30 Dec 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- access to the internet and a device with a webcam
- able to complete the study in English
Who cannot join
- 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
- using a gait aid device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Toronto - Athletic Centre
Toronto, Ontario, M5S 2W6
Deema Khalaf, BSc, +1 (416)-946-3624, deema.khalaf@utoronto.ca
Linda Trinh, PhD, +1 (416)-946-3624, linda.trinh@utoronto.ca
About this study
Official title: A Habit-Based Intervention to Reduce Sedentary Behaviour in Cancer Survivors: A Feasibility Study
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).
Read the detailed description
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.
- Conditions
- Cancer, Sedentary Behaviour
- Being tested
- Sedentary Behaviour Intervention, Active Control Group
- Keywords
- cancer survivorship, quality of life, physical function, cancer, remote delivery, feasibility, sedentary behaviour intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary Behaviour InterventionBehavioural
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.
Active Control GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Behaviour Intervention Group | Experimental | 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. Receives: Behavioral: Sedentary Behaviour Intervention |
| Active Control Group | Active comparator | 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. Receives: Other: Active Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (8 weeks).
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start30 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either the sedentary behaviour intervention group or the active control group. Participants in the sedentary behaviour intervention group will receive 8 weekly tick-sheets consisting of tips recommending to perform actions in the presence of everyday sues to reduce 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 via email. Both groups will be provided with wearable activity monitors (Fitbits), however the hourly physical inactivity reminders will be turned off for the active control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Trinh, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694479
- Sponsor's protocol ID
- 48969
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park C, Larsen B, Mogos M, Muchira J, Dietrich M, LaNoue M, Jean J, Norfleet J, Doyle A, Ahn S, Mulvaney S. A multiple technology-based and individually-tailored Sit Less program for people with cardiovascular disease: A randomized controlled trial study protocol. PLoS One. 2024 May 9;19(5):e0302582. doi: 10.1371/journal.pone.0302582. eCollection 2024.
PubMed 38722831Tam RM, Zablocki RW, Liu C, Narayan HK, Natarajan L, LaCroix AZ, Dillon L, Sakoulas E, Hartman SJ. Feasibility of a Health Coach Intervention to Reduce Sitting Time and Improve Physical Functioning Among Breast Cancer Survivors: Pilot Intervention Study. JMIR Cancer. 2023 Dec 19;9:e49934. doi: 10.2196/49934.
PubMed 38113082Gardner, B., Rebar, A. L., de Wit, S., & Lally, P. (2024). What is habit and how can it be used to change real-world behaviour? Narrowing the theory-reality gap. Social and Personality Psychology Compass, 18(6), e12975. https://doi.org/10.1111/spc3.12975
White I, Smith L, Aggio D, Shankar S, Begum S, Matei R, Fox KR, Hamer M, Iliffe S, Jefferis BJ, Tyler N, Gardner B. On Your Feet to Earn Your Seat: pilot RCT of a theory-based sedentary behaviour reduction intervention for older adults. Pilot Feasibility Stud. 2017 May 8;3:23. doi: 10.1186/s40814-017-0139-6. eCollection 2017.
PubMed 28491459Matei R, Thune-Boyle I, Hamer M, Iliffe S, Fox KR, Jefferis BJ, Gardner B. Acceptability of a theory-based sedentary behaviour reduction intervention for older adults ('On Your Feet to Earn Your Seat'). BMC Public Health. 2015 Jul 2;15:606. doi: 10.1186/s12889-015-1921-0.
PubMed 26135402Tremblay MS, Aubert S, Barnes JD, Saunders TJ, Carson V, Latimer-Cheung AE, Chastin SFM, Altenburg TM, Chinapaw MJM; SBRN Terminology Consensus Project Participants. Sedentary Behavior Research Network (SBRN) - Terminology Consensus Project process and outcome. Int J Behav Nutr Phys Act. 2017 Jun 10;14(1):75. doi: 10.1186/s12966-017-0525-8.
PubMed 28599680Sardinha LB, Santos DA, Silva AM, Baptista F, Owen N. Breaking-up sedentary time is associated with physical function in older adults. J Gerontol A Biol Sci Med Sci. 2015 Jan;70(1):119-24. doi: 10.1093/gerona/glu193. Epub 2014 Oct 16.
PubMed 25324221Gaskin CJ, Craike M, Mohebbi M, Salmon J, Courneya KS, Broadbent S, Livingston PM. Associations of objectively measured moderate-to-vigorous physical activity and sedentary behavior with quality of life and psychological well-being in prostate cancer survivors. Cancer Causes Control. 2016 Sep;27(9):1093-103. doi: 10.1007/s10552-016-0787-5. Epub 2016 Jul 28.
PubMed 27469939Gotay CC, Muraoka MY. Quality of life in long-term survivors of adult-onset cancers. J Natl Cancer Inst. 1998 May 6;90(9):656-67. doi: 10.1093/jnci/90.9.656.
PubMed 9586662Grusdat NP, Stauber A, Tolkmitt M, Schnabel J, Schubotz B, Wright PR, Schulz H. Routine cancer treatments and their impact on physical function, symptoms of cancer-related fatigue, anxiety, and depression. Support Care Cancer. 2022 May;30(5):3733-3744. doi: 10.1007/s00520-021-06787-5. Epub 2022 Jan 11.
PubMed 35018519Muhandiramge J, Orchard SG, Warner ET, van Londen GJ, Zalcberg JR. Functional Decline in the Cancer Patient: A Review. Cancers (Basel). 2022 Mar 8;14(6):1368. doi: 10.3390/cancers14061368.
PubMed 35326520
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Habit-Based Intervention to Reduce Sedentary Behaviour in Cancer Survivors: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07694479
- Acronym / sponsor ID
- 48969
- Conditions
- Cancer, Sedentary Behaviour
- Keywords
- cancer survivorship, quality of life, physical function, cancer, remote delivery, feasibility, sedentary behaviour intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either the sedentary behaviour intervention group or the active control group. Participants in the sedentary behaviour intervention group will receive 8 weekly tick-sheets consisting of tips recommending to perform actions in the presence of everyday sues to reduce 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 via email. Both groups will be provided with wearable activity monitors (Fitbits), however the hourly physical inactivity reminders will be turned off for the active control group.
| Arm | Type | Receives |
|---|---|---|
| Sedentary Behaviour Intervention Group | Experimental | Behavioral: Sedentary Behaviour InterventionThe 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 | Active comparator | Other: Active Control GroupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- access to the internet and a device with a webcam
Key exclusion criteria (5 listed)
- 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
- using a gait aid device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedentary Behaviour InterventionThe 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. | Behavioural | Sedentary Behaviour Intervention Group |
| Active Control GroupThe 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 |
Primary outcome
Enrollment
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Adherence
Time frame: From baseline (pre-intervention) to post-intervention (8 weeks).
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).
Attrition
Time frame: Assessed from baseline (pre-intervention) to post-intervention (8 weeks).
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.
Adverse Events
Time frame: From baseline (pre-intervention) to post-intervention (8 weeks).
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.
Participant Satisfaction
Time frame: Post-intervention (8 weeks).
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.
10 secondary outcomes
Objective Sedentary Behaviour
Time frame: Change from baseline (pre-intervention) to post-intervention (8 weeks).
Self-Reported Sedentary Behaviour
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Habit
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Physical Function
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Cancer-Specific Quality of Life
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
General-Health-Related Quality of Life
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Self-Reported Exercise
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Clinical Demographics
Time frame: Baseline (pre-intervention)
Demographic Variables
Time frame: Baseline (pre-intervention)
Fatigue
Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 38722831Park C, Larsen B, Mogos M, Muchira J, Dietrich M, LaNoue M, Jean J, Norfleet J, Doyle A, Ahn S, Mulvaney S. A multiple technology-based and individually-tailored Sit Less program for people with cardiovascular disease: A randomized controlled trial study protocol. PLoS One. 2024 May 9;19(5):e0302582. doi: 10.1371/journal.pone.0302582. eCollection 2024.
- Background: PubMed 38113082Tam RM, Zablocki RW, Liu C, Narayan HK, Natarajan L, LaCroix AZ, Dillon L, Sakoulas E, Hartman SJ. Feasibility of a Health Coach Intervention to Reduce Sitting Time and Improve Physical Functioning Among Breast Cancer Survivors: Pilot Intervention Study. JMIR Cancer. 2023 Dec 19;9:e49934. doi: 10.2196/49934.
- BackgroundGardner, B., Rebar, A. L., de Wit, S., & Lally, P. (2024). What is habit and how can it be used to change real-world behaviour? Narrowing the theory-reality gap. Social and Personality Psychology Compass, 18(6), e12975. https://doi.org/10.1111/spc3.12975
- Background: PubMed 28491459White I, Smith L, Aggio D, Shankar S, Begum S, Matei R, Fox KR, Hamer M, Iliffe S, Jefferis BJ, Tyler N, Gardner B. On Your Feet to Earn Your Seat: pilot RCT of a theory-based sedentary behaviour reduction intervention for older adults. Pilot Feasibility Stud. 2017 May 8;3:23. doi: 10.1186/s40814-017-0139-6. eCollection 2017.
- Background: PubMed 26135402Matei R, Thune-Boyle I, Hamer M, Iliffe S, Fox KR, Jefferis BJ, Gardner B. Acceptability of a theory-based sedentary behaviour reduction intervention for older adults ('On Your Feet to Earn Your Seat'). BMC Public Health. 2015 Jul 2;15:606. doi: 10.1186/s12889-015-1921-0.
- Background: PubMed 28599680Tremblay MS, Aubert S, Barnes JD, Saunders TJ, Carson V, Latimer-Cheung AE, Chastin SFM, Altenburg TM, Chinapaw MJM; SBRN Terminology Consensus Project Participants. Sedentary Behavior Research Network (SBRN) - Terminology Consensus Project process and outcome. Int J Behav Nutr Phys Act. 2017 Jun 10;14(1):75. doi: 10.1186/s12966-017-0525-8.
- Background: PubMed 25324221Sardinha LB, Santos DA, Silva AM, Baptista F, Owen N. Breaking-up sedentary time is associated with physical function in older adults. J Gerontol A Biol Sci Med Sci. 2015 Jan;70(1):119-24. doi: 10.1093/gerona/glu193. Epub 2014 Oct 16.
- Background: PubMed 27469939Gaskin CJ, Craike M, Mohebbi M, Salmon J, Courneya KS, Broadbent S, Livingston PM. Associations of objectively measured moderate-to-vigorous physical activity and sedentary behavior with quality of life and psychological well-being in prostate cancer survivors. Cancer Causes Control. 2016 Sep;27(9):1093-103. doi: 10.1007/s10552-016-0787-5. Epub 2016 Jul 28.
- Background: PubMed 9586662Gotay CC, Muraoka MY. Quality of life in long-term survivors of adult-onset cancers. J Natl Cancer Inst. 1998 May 6;90(9):656-67. doi: 10.1093/jnci/90.9.656.
- Background: PubMed 35018519Grusdat NP, Stauber A, Tolkmitt M, Schnabel J, Schubotz B, Wright PR, Schulz H. Routine cancer treatments and their impact on physical function, symptoms of cancer-related fatigue, anxiety, and depression. Support Care Cancer. 2022 May;30(5):3733-3744. doi: 10.1007/s00520-021-06787-5. Epub 2022 Jan 11.
- Background: PubMed 35326520Muhandiramge J, Orchard SG, Warner ET, van Londen GJ, Zalcberg JR. Functional Decline in the Cancer Patient: A Review. Cancers (Basel). 2022 Mar 8;14(6):1368. doi: 10.3390/cancers14061368.
- Canadian 24-Hour Movement GuidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary Behaviour Intervention in people with Cancer and Sedentary Behaviour, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07694479, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.