Health Behavior Change in High-Risk Colorectal Cancer Individuals

China Medical University, China

Status: Enrolling

Conditions: Colorectal Neoplasms; Health Behavior; Primary Prevention/Methods

Treatments: Behavioral: Multi-component Health Promotion Lifestyle Intervention; Other: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07262840

HBC-HR-CRC

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Has a prior diagnosis of any malignancy (cancer).
• Has a diagnosed severe psychiatric or psychological disorder.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Health Promotion Lifestyle Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Multi-component Health Promotion Lifestyle Intervention

Standard Care

Active Comparator group

Description:

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).

Treatment:

Other: Standard Care