Health BehaviorNCT07262840
Health Behavior Change in High-Risk Colorectal Cancer Individuals
A study testing Multi-component Health Promotion Lifestyle Intervention in people with Health Behavior and Colorectal Neoplasms, run by China Medical University, China at 1 site in China.
Trial summary
Background Colorectal cancer is a significant health concern. For individuals identified as being at high risk for developing this disease, adopting healthy lifestyle behaviors is a powerful way to lower that risk. However, starting and maintaining these new habits can be challenging. Read more about this study
- Who is it for?
- Ages 18 to 80 monthsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Colorectal Neoplasms, Primary Prevention/Methods
- What is being tested?
- Multi-component Health Promotion Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2025to 10 Feb 2026
- 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 18 to 80 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Meets the criteria for being at high-risk for colorectal cancer as defined by the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Colorectal Cancer Screening and the relevant Chinese expert consensus on colorectal cancer diagnosis and treatment.
- Age ≥ 18 years.
- Has normal verbal communication and comprehension abilities.
- Provides informed consent and voluntarily agrees to participate in the study.
Who cannot join
- Has a prior diagnosis of any malignancy (cancer).
- Has a diagnosed severe psychiatric or psychological disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
School of Nursing, China Medical University
Shenyang, Liaoning, 110122
Wenna Qian, PhD, +8613314021865, wenna13314021865@163.com
About this study
Official title: Facilitating Health Behavior Change in High-Risk Individuals for Colorectal Cancer: A Randomized Controlled Trial
Background Colorectal cancer is a significant health concern. For individuals identified as being at high risk for developing this disease, adopting healthy lifestyle behaviors is a powerful way to lower that risk. However, starting and maintaining these new habits can be challenging. This study aims to test a comprehensive support program designed to help high-risk individuals make and sustain these positive health behavior changes.
Purpose The main goal of this research is to see if a specially designed 12-week health promotion program can effectively help high-risk individuals improve their lifestyle (e.g., diet, exercise, smoking/alcohol use), increase their knowledge about colorectal cancer, and strengthen their confidence and motivation to stay healthy.
Read more
Study Groups Participants in this study will be randomly assigned (like flipping a coin) to one of two groups:
- The Intervention Group: This group will take part in the 12-week health promotion program.
- The Control Group: This group will receive general health information or standard care but will not participate in the special program.
Procedures The program for the Intervention Group includes:
- Educational Workshops: Five in-person group sessions to learn about cancer prevention, create personal health plans, and solve problems with others.
- Online Support: Regular health articles and tips sent through a private WeChat group.
- Daily Check-ins: Using the WeChat group for simple daily check-ins on exercise, fruit/vegetable intake, and smoking/alcohol use to build habit.
- Peer Support: Being paired with a "health buddy" and interacting with other participants for motivation.
All participants will be asked to complete several questionnaires at the beginning of the study, during the program, and after it ends (at 3 months) to measure their knowledge, beliefs, and lifestyle habits.
Duration The active program lasts for 12 weeks.
Potential Benefits Participants in the Intervention Group may benefit from improved health habits, a better understanding of how to reduce their cancer risk, and increased social support. Participants in the control group will receive general health information. If they wish, they will receive the same health materials and behavioral change intervention as the intervention group after the intervention concludes.
- Being tested
- Multi-component Health Promotion Lifestyle Intervention, Standard Care
- Keywords
- Health Promotion；Health Behavior；Lifestyle Intervention；High-Risk Population
- Medical subject headings
- Health Behavior, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component Health Promotion Lifestyle InterventionBehavioural
- Intervention Name: Multi-Component Health Promotion Lifestyle Intervention
- Description:
This is a structured, theory-based intervention designed to facilitate health behavior change in individuals at high risk for colorectal cancer. It is distinguished by its foundation in the Health Promotion Model and the Integrative Model of Health Behavior Change, and its use of a blended online and offline delivery model over a 12-week period.
The intervention is organized into five sequential modules:
Cognitive Reconstruction: Provides essential knowledge about colorectal cancer (etiology, risk factors) and disease prevention strategies.
Psychological Adjustment: Employs techniques from Motivational Interviewing to build intrinsic motivation and Acceptance and Commitment Therapy (ACT) to help participants manage distress and psychological barriers related to their cancer risk.
Health Behavior Establishment: Guides participants in creating personalized health plans and builds self-effic
Standard CareOther
Participants randomised to the control arm will receive standard care, which may include general health advice or publicly available educational pamphlets on colorectal cancer prevention. They will not receive any component of the structured multi-component health promotion lifestyle intervention (i.e., no group workshops, no WeChat-based check-ins, no psychological techniques training, and no facilitated peer support). However, they will be asked to complete all the same assessment questionnaires at the same time points as the intervention group. Upon completion of the final follow-up assessment, participants in this arm will be offered the opportunity to receive the full intervention program (wait-list design).
| Study group | Role | What they receive |
|---|---|---|
| Health Promotion Lifestyle Intervention Group | Experimental | Participants in this arm receive a 12-week, multi-component health promotion program based on the Health Promotion Model. The intervention includes: 1) Five in-person group workshops focusing on knowledge, motivation, planning, and maintenance; 2) Online support via a WeChat group for daily behavioral check-ins (e.g., exercise, diet) and peer support; 3) Educational articles and resources; 4) Techniques from Motivational Interviewing and Acceptance and Commitment Therapy to foster psychological adjustment and behavior change. Receives: Behavioral: Multi-component Health Promotion Lifestyle Intervention |
| Standard Care | Active comparator | Participants in this arm receive standard care, which may include general health information about colorectal cancer prevention. They do not participate in the structured workshops, online check-ins, or specialized support of the experimental intervention. They will complete all the same assessment questionnaires as the intervention group. They may be offered the intervention program after the study is complete (wait-list design). Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score change in the Health Promotion Lifestyle Scale for High-Risk Colorectal Cancer Population (HPLP-HRCP)
This is the primary outcome measure, assessed using the revised Health Promotion Lifestyle Profile for High-Risk Colorectal Cancer Population (HPLP-HRCP). This scale measures the level of health-promoting lifestyle behaviors. A higher total score indicates a better health-promoting lifestyle.
Measured: Baseline (Week 0), Post-intervention (Week 12)
Secondary outcomes (5)
Score change in Colorectal Cancer Knowledge Questionnaire (CRC-KQ)
Assessed using the 21-item Colorectal Cancer Knowledge Questionnaire. It consists of two dimensions: basic knowledge (15 items) and screening knowledge (6 items). Each correct answer scores 1 point. A higher total score indicates a higher level of colorectal cancer knowledge.
Measured: Baseline (Week 0), Post-intervention (Week 12).
Score change in the Champion Health Belief Model Scale (CHBMS)
Assessed using the Chinese version of the Champion Health Belief Model Scale. It contains 36 items across 6 dimensions: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, health motivation, and self-efficacy. A higher score on a 5-point Likert scale indicates stronger health beliefs toward adopting recommended health behaviors.
Measured: Baseline (Week 0), Post-intervention (Week 12).
Score change in the Multidimensional Health Locus of Control Scale (MHLC)
Assessed using the Chinese version of the Multidimensional Health Locus of Control Scale. It has 18 items across 3 subscales (6 items each): Internal, Powerful Others, and Chance. Each subscale is scored from 6 to 36 on a 6-point Likert scale. A higher score on a subscale indicates a stronger tendency towards that specific locus of control.
Measured: Baseline (Week 0), Post-intervention (Week 12).
Score change in the Kessler Psychological Distress Scale (K10)
Assessed using the Chinese version of the 10-item Kessler Psychological Distress Scale. Total scores range from 10 to 50. Higher scores indicate higher levels of psychological distress. Scores are categorized as: 10-15 (Well), 16-21 (Mild), 22-29 (Moderate), and 30-50 (Severe) distress.
Measured: Baseline (Week 0), Post-intervention (Week 12).
Score change in the Perceived Social Support Scale (PSSS)
Assessed using the Chinese version of the Perceived Social Support Scale. It contains 12 items across 3 dimensions: family, friends, and significant others. Each item is rated on a 7-point Likert scale. A higher total score indicates a higher level of perceived social support.
Measured: Baseline (Week 0), Post-intervention (Week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start10 Nov 2025
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenna Qian, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262840
- Sponsor's protocol ID
- HBC-HR-CRC
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What IPD will be shared? Individual participant data that underlie the results reported in the primary and secondary publications after de-identification. This will include demographic data, baseline characteristics, and all outcome measure scores (e.g., HPLP-HRCP, CRC-KQ, CHBMS, MHLC, K10, PSSS). When will IPD be available? Beginning 9 months after the publication of the main trial results and ending 36 months thereafter. Who can access the IPD?? Researchers who provide a methodologically sound proposal for use in an independent ethical review-approved meta-analysis or replication study. How can IPD be accessed? Proposals should be directed to the corresponding author via email. To gain access, requestors will need to sign a data access agreement. Data will be shared via a secure file transfer platform. What other documents will be available? The study protocol, statistical analysis plan, and informed consent form will be made available on ClinicalTrials.gov alongside the results.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Health Behavior Change in High-Risk Individuals for Colorectal Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07262840
- Acronym / sponsor ID
- HBC-HR-CRC
- Keywords
- Health Promotion；Health Behavior；Lifestyle Intervention；High-Risk Population
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 4 Dec 2025 (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.
Background Colorectal cancer is a significant health concern. For individuals identified as being at high risk for developing this disease, adopting healthy lifestyle behaviors is a powerful way to lower that risk. However, starting and maintaining these new habits can be challenging. This study aims to test a comprehensive support program designed to help high-risk individuals make and sustain these positive health behavior changes.
Purpose The main goal of this research is to see if a specially designed 12-week health promotion program can effectively help high-risk individuals improve their lifestyle (e.g., diet, exercise, smoking/alcohol use), increase their knowledge about colorectal cancer, and strengthen their confidence and motivation to stay healthy.
Study Groups Participants in this study will be randomly assigned (like flipping a coin) to one of two groups:
- The Intervention Group: This group will take part in the 12-week health promotion program.
- The Control Group: This group will receive general health information or standard care but will not participate in the special program.
Procedures The program for the Intervention Group includes:
- Educational Workshops: Five in-person group sessions to learn about cancer prevention, create personal health plans, and solve problems with others.
- Online Support: Regular health articles and tips sent through a private WeChat group.
- Daily Check-ins: Using the WeChat group for simple daily check-ins on exercise, fruit/vegetable intake, and smoking/alcohol use to build habit.
- Peer Support: Being paired with a "health buddy" and interacting with other participants for motivation.
All participants will be asked to complete several questionnaires at the beginning of the study, during the program, and after it ends (at 3 months) to measure their knowledge, beliefs, and lifestyle habits.
Duration The active program lasts for 12 weeks.
Potential Benefits Participants in the Intervention Group may benefit from improved health habits, a better understanding of how to reduce their cancer risk, and increased social support. Participants in the control group will receive general health information. If they wish, they will receive the same health materials and behavioral change intervention as the intervention group after the intervention concludes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Promotion Lifestyle Intervention Group | Experimental | Behavioral: Multi-component Health Promotion Lifestyle InterventionParticipants in this arm receive a 12-week, multi-component health promotion program based on the Health Promotion Model. The intervention includes: 1) Five in-person group workshops focusing on knowledge, motivation, planning, and maintenance; 2) Online support via a WeChat group for daily behavioral check-ins (e.g., exercise, diet) and peer support; 3) Educational articles and resources; 4) Techniques from Motivational Interviewing and Acceptance and Commitment Therapy to foster psychological adjustment and behavior change. |
| Standard Care | Active comparator | Other: Standard CareParticipants in this arm receive standard care, which may include general health information about colorectal cancer prevention. They do not participate in the structured workshops, online check-ins, or specialized support of the experimental intervention. They will complete all the same assessment questionnaires as the intervention group. They may be offered the intervention program after the study is complete (wait-list design). |
Who may qualify
- Ages
- 18 to 80 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Meets the criteria for being at high-risk for colorectal cancer as defined by the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Colorectal Cancer Screening and the relevant Chinese expert consensus on colorectal cancer diagnosis and treatment.
- Age ≥ 18 years.
- Has normal verbal communication and comprehension abilities.
- Provides informed consent and voluntarily agrees to participate in the study.
Key exclusion criteria (2 listed)
- Has a prior diagnosis of any malignancy (cancer).
- Has a diagnosed severe psychiatric or psychological disorder.
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 |
|---|---|---|
| Multi-component Health Promotion Lifestyle Intervention1. Intervention Name: Multi-Component Health Promotion Lifestyle Intervention 2. Description: This is a structured, theory-based intervention designed to facilitate health behavior change in individuals at high risk for colorectal cancer. It is distinguished by its foundation in the Health Promotion Model and the Integrative Model of Health Behavior Change, and its use of a blended online and offline delivery model over a 12-week period. The intervention is organized into five sequential modules: Cognitive Reconstruction: Provides essential knowledge about colorectal cancer (etiology, risk factors) and disease prevention strategies. Psychological Adjustment: Employs techniques from Motivational Interviewing to build intrinsic motivation and Acceptance and Commitment Therapy (ACT) to help participants manage distress and psychological barriers related to their cancer risk. Health Behavior Establishment: Guides participants in creating personalized health plans and builds self-effic | Behavioural | Health Promotion Lifestyle Intervention Group |
| Standard CareParticipants randomised to the control arm will receive standard care, which may include general health advice or publicly available educational pamphlets on colorectal cancer prevention. They will not receive any component of the structured multi-component health promotion lifestyle intervention (i.e., no group workshops, no WeChat-based check-ins, no psychological techniques training, and no facilitated peer support). However, they will be asked to complete all the same assessment questionnaires at the same time points as the intervention group. Upon completion of the final follow-up assessment, participants in this arm will be offered the opportunity to receive the full intervention program (wait-list design). | Other | Standard Care |
Primary outcome
Score change in the Health Promotion Lifestyle Scale for High-Risk Colorectal Cancer Population (HPLP-HRCP)
Time frame: Baseline (Week 0), Post-intervention (Week 12)
This is the primary outcome measure, assessed using the revised Health Promotion Lifestyle Profile for High-Risk Colorectal Cancer Population (HPLP-HRCP). This scale measures the level of health-promoting lifestyle behaviors. A higher total score indicates a better health-promoting lifestyle.
5 secondary outcomes
Score change in Colorectal Cancer Knowledge Questionnaire (CRC-KQ)
Time frame: Baseline (Week 0), Post-intervention (Week 12).
Score change in the Champion Health Belief Model Scale (CHBMS)
Time frame: Baseline (Week 0), Post-intervention (Week 12).
Score change in the Multidimensional Health Locus of Control Scale (MHLC)
Time frame: Baseline (Week 0), Post-intervention (Week 12).
Score change in the Kessler Psychological Distress Scale (K10)
Time frame: Baseline (Week 0), Post-intervention (Week 12).
Score change in the Perceived Social Support Scale (PSSS)
Time frame: Baseline (Week 0), Post-intervention (Week 12).
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 4 Dec 2025.
- Individual participant dataSharing planned: Yes. What IPD will be shared? Individual participant data that underlie the results reported in the primary and secondary publications after de-identification. This will include demographic data, baseline characteristics, and all outcome measure scores (e.g., HPLP-HRCP, CRC-KQ, CHBMS, MHLC, K10, PSSS). When will IPD be available? Beginning 9 months after the publication of the main trial results and ending 36 months thereafter. Who can access the IPD?? Researchers who provide a methodologically sound proposal for use in an independent ethical review-approved meta-analysis or replication study. How can IPD be accessed? Proposals should be directed to the corresponding author via email. To gain access, requestors will need to sign a data access agreement. Data will be shared via a secure file transfer platform. What other documents will be available? The study protocol, statistical analysis plan, and informed consent form will be made available on ClinicalTrials.gov alongside the results.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component Health Promotion Lifestyle Intervention in people with Health Behavior and Colorectal Neoplasms, run by China Medical University, China at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jialin Li (15909836297, lijlpanda@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score change in the Health Promotion Lifestyle Scale for High-Risk Colorectal Cancer Population (HPLP-HRCP) (time frame: Baseline (Week 0), Post-intervention (Week 12)). 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 4 Dec 2025.