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Colorectal NeoplasmsNCT07845877

An Intervention to Reduce Sedentary Behavior and Promote Physical Activity in Colorectal Cancer Chemotherapy

A study testing Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapy in people with Colorectal Neoplasms and Sedentary Behavior, run by Yonsei University.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Colorectal Neoplasms, Sedentary Behavior
What is being tested?
Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 31 Aug 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Newly advised by the attending physician to restrict physical activity
  • Any injury or condition that, in the investigator's judgment, makes study participation inappropriate

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jiyeon Lee, Professor contact

+82-2-2228-3255

Jiyeonest@yuhs.ac

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapy
Keywords
Colorectal cancer, Chemotherapy, Sedentary behavior, Physical activity, Wearable device, Behavior change, Feasibility study
Medical subject headings
Colorectal Neoplasms, Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapyBehavioural

    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.

Study groups in NCT07845877
Study groupRoleWhat they receive
Intervention groupExperimentalAll 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.
Receives: Behavioral: Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the intervention: acceptability

    Acceptability: satisfaction/ease/burden/recommendation, 5-point Likert

    Measured: At 3 weeks after intervention start (immediately following completion of the intervention)

  2. Feasibility of the intervention: demand (1) Recruitment rate

    enrolled participants / eligible individuals approached (%)

    Measured: At enrollment (baseline)

  3. Feasibility of the intervention: demand (2) Retention rate

    participants completing the post-intervention assessment / enrolled participants (%)

    Measured: At 3 weeks after intervention start (immediately following completion of the intervention)

  4. Feasibility of the intervention: implementation (intervention adherence rate)

    overall adherence rate to intervention components (%)

    Measured: At 3 weeks after intervention start (immediately following completion of the intervention)

  5. Feasibility of the intervention: practicality

    CTCAE-graded adverse events and technical faults (n)

    Measured: At 3 weeks after intervention start (immediately following completion of the intervention)

Secondary outcomes (5)
  1. Change from baseline in sedentary behavior

    Sedentary time (min/day)

    Measured: Three weeks before, throughout the 3-week intervention, and three weeks after the intervention.

  2. Change from baseline in physical activity

    Physical activity time (min/day)

    Measured: Three weeks before, throughout the 3-week intervention, and three weeks after the intervention.

  3. Change from baseline in symptoms at 3 weeks

    EORTC QLQ-C30/CR29 symptom scales (0-100; higher scores indicate worse symptoms)

    Measured: Baseline and 3 weeks after intervention start

  4. Change from baseline in quality of life at 3 weeks

    EORTC QLQ-C30 global health status/QoL scale (0-100; higher scores indicate better quality of life)

    Measured: Baseline and 3 weeks after intervention start

  5. Change from baseline in self-efficacy to reduce sedentary behavior at 3 weeks

    Self-Efficacy to Reduce Sedentary Behavior (SRSB) Questionnaire (9-item mean score, 1-5; higher scores indicate greater self-efficacy)

    Measured: Baseline and 3 weeks after intervention start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07845877
Sponsor's protocol ID
4-2026-0040
Status last verified
Sep 2026
First submitted
29 Jun 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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