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

NCT07845877 | Not Yet Recruiting

• 1 other identifier: 4-2026-0040
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Colorectal Neoplasms; Sedentary Behavior

Keywords

Colorectal cancer; Chemotherapy; Sedentary behavior; Physical activity; Wearable device; Behavior change; Feasibility study

Outcome Measures

Primary Outcomes (5)

• Feasibility of the intervention: acceptability

  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

  enrolled participants / eligible individuals approached (%)

  At enrollment (baseline)

• Feasibility of the intervention: demand (2) Retention rate

  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)

  overall adherence rate to intervention components (%)

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

• Feasibility of the intervention: practicality

  CTCAE-graded adverse events and technical faults (n)

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

Secondary Outcomes (5)

• Change from baseline in sedentary behavior

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

• Change from baseline in physical activity

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

• Change from baseline in symptoms at 3 weeks

  Baseline and 3 weeks after intervention start

• Change from baseline in quality of life at 3 weeks

  Baseline and 3 weeks after intervention start

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

  Baseline and 3 weeks after intervention start

Study Arms (1)

Intervention group

EXPERIMENTAL

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.

Behavioral: Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapy

Interventions

Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapy BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Central Study Contacts

Jiyeon Lee, Professor

CONTACT

+82-2-2228-3255; Jiyeonest@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share