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NCT Number: NCT07262840

Health Behavior Change in High-Risk Colorectal Cancer Individuals

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.

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Key information

Conditions

Health Behavior Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Primary Prevention/Methods Rectal Diseases

Age range

18 month–80 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, China Medical University

Shenyang, Liaoning, 110122, China

Location status: Recruiting

Location contact

Wenna Qian, PhD

CONTACT

[email protected]

+8613314021865

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-component Health Promotion Lifestyle Intervention

Behavioral
  • 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 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).

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: Baseline (Week 0), Post-intervention (Week 12).

    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.

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

    Time frame: Baseline (Week 0), Post-intervention (Week 12).

    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.

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

    Time frame: Baseline (Week 0), Post-intervention (Week 12).

    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.

  4. Score change in the Kessler Psychological Distress Scale (K10)

    Time frame: Baseline (Week 0), Post-intervention (Week 12).

    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.

  5. Score change in the Perceived Social Support Scale (PSSS)

    Time frame: Baseline (Week 0), Post-intervention (Week 12).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jialin Li

CONTACT

[email protected]

15909836297

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study title

Facilitating Health Behavior Change in High-Risk Individuals for Colorectal Cancer: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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