Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

2 lipca 2026 zaktualizowane przez: 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).

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5S 2W6
        • Rekrutacyjny
        • University of Toronto - Athletic Centre
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Deema Khalaf, BSc
        • Pod-śledczy:
          • Linda Trinh, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny 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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Enrollment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Objective Sedentary Behaviour
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Toronto

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 grudnia 2025

Zakończenie podstawowe (Szacowany)

1 września 2026

Ukończenie studiów (Szacowany)

1 września 2026

Daty rejestracji na studia

Pierwszy przesłany

2 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 lipca 2026

Pierwszy wysłany (Rzeczywisty)

10 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 48969

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Nowotwór

Badania kliniczne na Sedentary Behaviour Intervention

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Bosnia & Herzegovina

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj