Health Behavior Change in High-Risk Colorectal Cancer Individuals

NCT ID: NCT07262840

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-10
• Study Completion Date: 2026-02-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Health Promotion Lifestyle Intervention Group

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.

Group Type: EXPERIMENTAL

Multi-component Health Promotion Lifestyle Intervention

Intervention Type: BEHAVIORAL

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

Standard Care

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).

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

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).

Interventions

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

Intervention Type: BEHAVIORAL

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 80 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Wenna Qian

Doctoral Researcher, School of Nursing, China Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Nursing, China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jialin Li

Role: CONTACT

lijlpanda@163.com

15909836297

Facility Contacts

Wenna Qian, PhD

Role: primary

wenna13314021865@163.com

+8613314021865

Other Identifiers

HBC-HR-CRC

Identifier Type: -

Identifier Source: org_study_id