Health Behavior Change in High-Risk Colorectal Cancer Individuals
NCT07262840 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-12-04
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. 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:
1. The Intervention Group: This group will take part in the 12-week health promotion program.
2. 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.
Conditions
- Health Behavior
- Colorectal Neoplasms
- Primary Prevention/Methods
Interventions
- BEHAVIORAL
-
Multi-component Health Promotion Lifestyle Intervention
1. 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
- OTHER
-
Standard Care
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).
Sponsors & Collaborators
-
China Medical University, China
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Months
- Max Age
- 80 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-10
- Primary Completion
- 2026-02-10
- Completion
- 2026-02-10
Countries
- China
Study Locations
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