An Intervention to Reduce Sedentary Behavior and Promote Physical Activity in Colorectal Cancer Chemotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapy
BehavioralA 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the intervention: acceptability
Acceptability: satisfaction/ease/burden/recommendation, 5-point Likert
Time frame
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 (%)
Time frame
At enrollment (baseline)3
Feasibility of the intervention: demand (2) Retention rate
participants completing the post-intervention assessment / enrolled participants (%)
Time frame
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 (%)
Time frame
At 3 weeks after intervention start (immediately following completion of the intervention)Secondary outcomes
1
Change from baseline in sedentary behavior
Sedentary time (min/day)
Time frame
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)
Time frame
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)
Time frame
Baseline and 3 weeks after intervention start4
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)
Time frame
Baseline and 3 weeks after intervention startLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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