Feasibility of a Habit-Based Intervention to Reduce Sedentary Behaviour in Cancer Survivors

Official title

A Habit-Based Intervention to Reduce Sedentary Behaviour in Cancer Survivors: A Feasibility Study

Overview

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.

Interventions

• Behavioral Sedentary Behaviour Intervention
  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 on
• Other Active Control Group
  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.

Primary outcome measures

• Enrollment [Time frame: Change from baseline (pre- intervention) to post-intervention (8 weeks).]
• Adherence [Time frame: From baseline (pre-intervention) to post-intervention (8 weeks).]
• Attrition [Time frame: Assessed from baseline (pre-intervention) to post-intervention (8 weeks).]
• Adverse Events [Time frame: From baseline (pre-intervention) to post-intervention (8 weeks).]
• Participant Satisfaction [Time frame: Post-intervention (8 weeks).]

Secondary outcome measures (10)

• 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).]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Canada · 1 center

• University of Toronto - Athletic Centre — Toronto

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. PMID 38722831
• 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 38113082
• 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
• 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 28491459
• 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 26135402
• 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 28599680
• 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 25324221
• 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 27469939

Identifiers

NCT: NCT07694479 · 48969

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗