An Intervention to Reduce Sedentary Behavior and Promote Physical Activity in Colorectal Cancer Chemotherapy
Development and Feasibility Evaluation of an Intervention to Reduce Sedentary Behavior and Promote Physical Activity in Patients With Colorectal Cancer Undergoing Chemotherapy
This single-group feasibility study develops and evaluates an intervention designed to reduce sedentary behavior and promote physical activity in patients with colorectal cancer undergoing chemotherapy. During chemotherapy, treatment-related symptoms such as fatigue often lead to reduced physical activity and prolonged sitting time. Replacing sedentary time with light-intensity movement is associated with improved metabolic outcomes and a lower risk of several chronic conditions, including cancer. The intervention is developed using the Capability, Opportunity, Motivation-Behavior (COM-B) model and the Behavior Change Wheel (BCW), and is delivered over 3 weeks using a smartwatch. It comprises smartwatch-based prompts to interrupt prolonged sitting, symptom assessment and symptom-management education, and feedback on physical activity and sedentary behavior. Sedentary behavior and physical activity are measured objectively by smartwatch continuously before, during, and after the 3-week intervention. The primary aim is to evaluate the feasibility of the intervention across the domains of acceptability, demand, implementation, and practicality. Secondary aims explore preliminary changes in physical activity, sedentary behavior, symptoms, health-related quality of life, and self-efficacy to reduce sedentary behavior. The findings are intended to inform the development of future interventions and nursing care to support health management in patients with cancer.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Background and rationale: Patients with colorectal cancer undergoing chemotherapy frequently experience symptoms such as fatigue that reduce physical activity and increase sedentary time. Prolonged sedentary behavior is independently associated with adverse health outcomes, whereas replacing sitting with light-intensity activity confers metabolic and other health benefits. Reducing sedentary behavior is a feasible, low-burden behavioral target that may be more attainable than structured exercise during active treatment. Continuous, objective monitoring of activity and symptoms using a wearable device, combined with tailored feedback, offers a practical approach for this population.
Objective: To develop a Capability, Opportunity, Motivation-Behavior (COM-B) based intervention to reduce sedentary behavior and promote physical activity in patients with colorectal cancer undergoing chemotherapy, and to evaluate its feasibility.
Intervention development: The intervention is developed using the COM-B model and the Behavior Change Wheel (BCW). A behavioral diagnosis is conducted across the COM-B components (capability, opportunity, motivation). Relevant intervention functions (education, training, enablement, environmental restructuring) and behavior change techniques (e.g., prompts/cues, self-monitoring of behavior, feedback on behavior, goal setting, problem solving, action planning, information about health consequences, verbal persuasion about capability, social rewards) are selected and mapped to interrupt prolonged sitting. The draft intervention undergoes expert review, and content validity is assessed using a 4-point scale with reference to the Item-level Content Validity Index (I-CVI) and Scale-level Content Validity Index (S-CVI); the intervention is refined based on expert feedback.
Study design and procedure: A single-group, non-randomized feasibility study with a pre-post test design is conducted. After providing written informed consent and confirming eligibility, each participant receives a study-provided smartwatch and participates in a 3-week intervention. Sedentary behavior and physical activity are recorded objectively by the smartwatch continuously for 3 weeks before, during, and 3 weeks after the intervention. The intervention comprises five core components, with the central target of interrupting prolonged sitting: when 60 minutes of continuous sitting is detected during waking hours, the participant is prompted to perform at least 1-2 minutes of light-intensity activity. The components are: (1) smartwatch-based sedentary prompts (vibration alerts after 60 minutes of continuous sitting, with guided light-activity options); (2) self-monitoring of sedentary behavior and physical activity via the smartwatch app; (3) structured weekly nurse feedback delivered by telephone (10-15 minutes; reviewing weekly activity data, reinforcing successes, and setting condition-adjusted goals); (4) weekly electronic symptom monitoring using the ESAS-r Cancer; and (5) tailored symptom-management education addressing treatment-related symptoms (e.g., fatigue, pain) as key barriers to reducing sedentary behavior. Survey-based outcomes are assessed at two time points (pre- and post-intervention) to enable pre-post comparison, scheduled to coincide with routine outpatient visits, so no additional hospital visits are required.
Measurements: Objective sedentary behavior and physical activity (smartwatch); subjective physical activity (GPAQ); symptoms and quality of life (EORTC QLQ-C30 & CR29); self-efficacy to reduce sedentary behavior (SRSB); and feasibility of the intervention (acceptability, demand, implementation, practicality).
Sample size: Forty participants are enrolled. Statistical analysis: Data are analyzed using SPSS/WIN 29.0 (alpha = .05). General and clinical characteristics and all feasibility outcomes are summarized using descriptive statistics. As exploratory secondary analyses, changes in objective sedentary behavior and physical activity across the three time points (pre-, during, and post-intervention) are analyzed using repeated-measures ANOVA, and survey-based outcomes measured at two time points are compared using ANCOVA.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Jiyeon Lee, Professor
- Numer telefonu: +82-2-2228-3255
- E-mail: Jiyeonest@yuhs.ac
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Diagnosed with colorectal cancer (stage 2 or 3) and scheduled to receive or currently receiving chemotherapy
- Able to use a smartwatch and respond to smartphone-based surveys
- Able to read and understand Korean and provide written informed consent
- ECOG performance status of 0 or 1
Exclusion Criteria:
- Newly advised by the attending physician to restrict physical activity
- Any injury or condition that, in the investigator's judgment, makes study participation inappropriate
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Eksperymentalny: Intervention group
All participants receive the 3-week smartwatch-based behavioral intervention to reduce sedentary behavior and promote physical activity. Sedentary behavior and physical activity are monitored using the smartwatch for 3 weeks before, throughout, and for 3 weeks after the intervention. |
A 3-week, COM-B based behavioral intervention delivered via a smartwatch, primarily targeting the interruption of prolonged sitting: when 60 minutes of continuous sitting is detected during waking hours, the participant is prompted to perform at least 1-2 minutes of light-intensity activity. It comprises five core components: (1) smartwatch-based sedentary prompts (vibration alerts after 60 minutes of continuous sitting, with guided light-activity options); (2) self-monitoring of sedentary behavior and physical activity; (3) structured weekly nurse feedback by telephone (10-15 minutes; reviewing weekly activity data, reinforcing successes, and setting condition-adjusted goals); (4) weekly electronic symptom monitoring using the ESAS-r Cancer; and (5) tailored symptom-management education addressing treatment-related symptoms (e.g., fatigue, pain) as key barriers to reducing sedentary behavior. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Feasibility of the intervention: acceptability
Ramy czasowe: At 3 weeks after intervention start (immediately following completion of the intervention)
|
Acceptability: satisfaction/ease/burden/recommendation, 5-point Likert |
At 3 weeks after intervention start (immediately following completion of the intervention)
|
|
Feasibility of the intervention: demand (1) Recruitment rate
Ramy czasowe: At enrollment (baseline)
|
enrolled participants / eligible individuals approached (%) |
At enrollment (baseline)
|
|
Feasibility of the intervention: demand (2) Retention rate
Ramy czasowe: At 3 weeks after intervention start (immediately following completion of the intervention)
|
participants completing the post-intervention assessment / enrolled participants (%) |
At 3 weeks after intervention start (immediately following completion of the intervention)
|
|
Feasibility of the intervention: implementation (intervention adherence rate)
Ramy czasowe: At 3 weeks after intervention start (immediately following completion of the intervention)
|
overall adherence rate to intervention components (%) |
At 3 weeks after intervention start (immediately following completion of the intervention)
|
|
Feasibility of the intervention: practicality
Ramy czasowe: At 3 weeks after intervention start (immediately following completion of the intervention)
|
CTCAE-graded adverse events and technical faults (n) |
At 3 weeks after intervention start (immediately following completion of the intervention)
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from baseline in sedentary behavior
Ramy czasowe: Three weeks before, throughout the 3-week intervention, and three weeks after the intervention.
|
Sedentary time (min/day) |
Three weeks before, throughout the 3-week intervention, and three weeks after the intervention.
|
|
Change from baseline in physical activity
Ramy czasowe: Three weeks before, throughout the 3-week intervention, and three weeks after the intervention.
|
Physical activity time (min/day) |
Three weeks before, throughout the 3-week intervention, and three weeks after the intervention.
|
|
Change from baseline in symptoms at 3 weeks
Ramy czasowe: Baseline and 3 weeks after intervention start
|
EORTC QLQ-C30/CR29 symptom scales (0-100; higher scores indicate worse symptoms) |
Baseline and 3 weeks after intervention start
|
|
Change from baseline in quality of life at 3 weeks
Ramy czasowe: Baseline and 3 weeks after intervention start
|
EORTC QLQ-C30 global health status/QoL scale (0-100; higher scores indicate better quality of life) |
Baseline and 3 weeks after intervention start
|
|
Change from baseline in self-efficacy to reduce sedentary behavior at 3 weeks
Ramy czasowe: Baseline and 3 weeks after intervention start
|
Self-Efficacy to Reduce Sedentary Behavior (SRSB) Questionnaire (9-item mean score, 1-5; higher scores indicate greater self-efficacy) |
Baseline and 3 weeks after intervention start
|
Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 4-2026-0040
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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