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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Are there results?
- Not yet: the study is under way
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.
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.
- Conditions
- Colorectal Neoplasms, Sedentary Behavior
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
Feasibility of the intervention: demand (1) Recruitment rate
enrolled participants / eligible individuals approached (%)
Measured: At enrollment (baseline)
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)
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)
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)
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.
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.
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
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
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.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Evaluation of an Intervention to Reduce Sedentary Behavior and Promote Physical Activity in Patients With Colorectal Cancer Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07845877
- Acronym / sponsor ID
- 4-2026-0040
- Conditions
- Colorectal Neoplasms, Sedentary Behavior
- Keywords
- Colorectal cancer, Chemotherapy, Sedentary behavior, Physical activity, Wearable device, Behavior change, Feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapyAll 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Newly advised by the attending physician to restrict physical activity
- Any injury or condition that, in the investigator's judgment, makes study participation inappropriate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedentary behavior reduction intervention for patients with colorectal cancer undergoing chemotherapyA 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. | Behavioural | Intervention group |
Primary outcome
Feasibility of the intervention: acceptability
Time frame: At 3 weeks after intervention start (immediately following completion of the intervention)
Acceptability: satisfaction/ease/burden/recommendation, 5-point Likert
Feasibility of the intervention: demand (1) Recruitment rate
Time frame: At enrollment (baseline)
enrolled participants / eligible individuals approached (%)
Feasibility of the intervention: demand (2) Retention rate
Time frame: At 3 weeks after intervention start (immediately following completion of the intervention)
participants completing the post-intervention assessment / enrolled participants (%)
Feasibility of the intervention: implementation (intervention adherence rate)
Time frame: At 3 weeks after intervention start (immediately following completion of the intervention)
overall adherence rate to intervention components (%)
Feasibility of the intervention: practicality
Time frame: At 3 weeks after intervention start (immediately following completion of the intervention)
CTCAE-graded adverse events and technical faults (n)
5 secondary outcomes
Change from baseline in sedentary behavior
Time frame: Three weeks before, throughout the 3-week intervention, and three weeks after the intervention.
Change from baseline in physical activity
Time frame: Three weeks before, throughout the 3-week intervention, and three weeks after the intervention.
Change from baseline in symptoms at 3 weeks
Time frame: Baseline and 3 weeks after intervention start
Change from baseline in quality of life at 3 weeks
Time frame: Baseline and 3 weeks after intervention start
Change from baseline in self-efficacy to reduce sedentary behavior at 3 weeks
Time frame: Baseline and 3 weeks after intervention start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiyeon Lee, Professor (+82-2-2228-3255, Jiyeonest@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention: acceptability (time frame: At 3 weeks after intervention start (immediately following completion of the intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.