Health Behavior Change in High-Risk Colorectal Cancer Individuals

NCT07262840 | Recruiting

• 1 other identifier: HBC-HR-CRC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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:

• 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

Primary Prevention/Methods; Colorectal Neoplasms; Health Behavior

Keywords

Health Promotion；Health Behavior；Lifestyle Intervention；High-Risk Population

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Week 0), Post-intervention (Week 12)

Secondary Outcomes (5)

• Score change in Colorectal Cancer Knowledge Questionnaire (CRC-KQ)

  Baseline (Week 0), Post-intervention (Week 12).

• Score change in the Champion Health Belief Model Scale (CHBMS)

  Baseline (Week 0), Post-intervention (Week 12).

• Score change in the Multidimensional Health Locus of Control Scale (MHLC)

  Baseline (Week 0), Post-intervention (Week 12).

• Score change in the Kessler Psychological Distress Scale (K10)

  Baseline (Week 0), Post-intervention (Week 12).

• Score change in the Perceived Social Support Scale (PSSS)

  Baseline (Week 0), Post-intervention (Week 12).

Study Arms (2)

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.

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).

Other: Standard Care

Interventions

Multi-component Health Promotion Lifestyle Intervention 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

Health Promotion Lifestyle Intervention Group

Standard Care 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).

Standard Care

Eligibility Criteria

• Age: 18 Months - 80 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

School of Nursing, China Medical University

Shenyang, Liaoning, 110122, China

RECRUITING

MeSH Terms

Conditions

Health Behavior; Colorectal Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jialin Li

CONTACT

15909836297; lijlpanda@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher, School of Nursing, China Medical University

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 4, 2025
• Study Start: November 10, 2025
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)