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

2. Juli 2026 aktualisiert von: Linda Trinh, University of Toronto

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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5S 2W6
        • Rekrutierung
        • University of Toronto - Athletic Centre
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Deema Khalaf, BSc
        • Unterermittler:
          • Linda Trinh, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Sedentary Behaviour Intervention 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.
Verhalten: 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 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.
Aktiver Komparator: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Enrollment
Zeitfenster: 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.
Change from baseline (pre- intervention) to post-intervention (8 weeks).
Adherence
Zeitfenster: 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).
From baseline (pre-intervention) to post-intervention (8 weeks).
Attrition
Zeitfenster: 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.
Assessed from baseline (pre-intervention) to post-intervention (8 weeks).
Adverse Events
Zeitfenster: 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.
From baseline (pre-intervention) to post-intervention (8 weeks).
Participant Satisfaction
Zeitfenster: 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.
Post-intervention (8 weeks).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective Sedentary Behaviour
Zeitfenster: Change from baseline (pre-intervention) to post-intervention (8 weeks).
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.
Change from baseline (pre-intervention) to post-intervention (8 weeks).
Self-Reported Sedentary Behaviour
Zeitfenster: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Change from baseline (pre- intervention) to post-intervention (8 weeks).
Habit
Zeitfenster: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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).
Change from baseline (pre- intervention) to post-intervention (8 weeks).
Physical Function
Zeitfenster: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Change from baseline (pre- intervention) to post-intervention (8 weeks).
Cancer-Specific Quality of Life
Zeitfenster: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Change from baseline (pre- intervention) to post-intervention (8 weeks).
General-Health-Related Quality of Life
Zeitfenster: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Change from baseline (pre- intervention) to post-intervention (8 weeks).
Self-Reported Exercise
Zeitfenster: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Change from baseline (pre- intervention) to post-intervention (8 weeks).
Clinical Demographics
Zeitfenster: Baseline (pre-intervention)
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.
Baseline (pre-intervention)
Demographic Variables
Zeitfenster: Baseline (pre-intervention)
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.
Baseline (pre-intervention)
Fatigue
Zeitfenster: Change from baseline (pre- intervention) to post-intervention (8 weeks).
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.
Change from baseline (pre- intervention) to post-intervention (8 weeks).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Toronto

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Dezember 2025

Primärer Abschluss (Geschätzt)

1. September 2026

Studienabschluss (Geschätzt)

1. September 2026

Studienanmeldedaten

Zuerst eingereicht

2. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 48969

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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