NCT07694479

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Dec 2025Sep 2026

Study Start

First participant enrolled

December 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 2, 2026

Last Update Submit

July 2, 2026

Conditions

CancerSedentary Behaviour

Keywords

cancer survivorshipquality of lifephysical functioncancerremote deliveryfeasibilitysedentary behaviour intervention

Outcome Measures

Primary Outcomes (5)

  • 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.

    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).

    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.

    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.

    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.

    Post-intervention (8 weeks).

Secondary Outcomes (10)

  • Objective Sedentary Behaviour

    Change from baseline (pre-intervention) to post-intervention (8 weeks).

  • Self-Reported Sedentary Behaviour

    Change from baseline (pre- intervention) to post-intervention (8 weeks).

  • Habit

    Change from baseline (pre- intervention) to post-intervention (8 weeks).

  • Physical Function

    Change from baseline (pre- intervention) to post-intervention (8 weeks).

  • Cancer-Specific Quality of Life

    Change from baseline (pre- intervention) to post-intervention (8 weeks).

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Other: Active Control Group

Interventions

Sedentary Behaviour InterventionBEHAVIORAL

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.

Sedentary Behaviour Intervention Group
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.

Active Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto - Athletic Centre

Toronto, Ontario, M5S 2W6, Canada

RECRUITING

Related Publications (11)

  • 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.

    PMID: 38722831BACKGROUND

  • Tam 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.

    PMID: 38113082BACKGROUND

  • Gardner, 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

  • 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.

    PMID: 28491459BACKGROUND

  • Matei 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.

    PMID: 26135402BACKGROUND

  • Tremblay 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.

    PMID: 28599680BACKGROUND

  • Sardinha 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.

    PMID: 25324221BACKGROUND

  • Gaskin 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.

    PMID: 27469939BACKGROUND

  • Gotay 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.

    PMID: 9586662BACKGROUND

  • Grusdat 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.

    PMID: 35018519BACKGROUND

  • Muhandiramge 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.

    PMID: 35326520BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will only be aware that the researchers are comparing the two conditions; they will be blinded to the study hypotheses.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 10, 2026

Study Start

December 30, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)