Facilitating Health Behavior Change in High-Risk Individuals for Colorectal Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Score change in the Health Promotion Lifestyle Scale for High-Risk Colorectal Cancer Population (HPLP-HRCP)
研究概览
简要总结
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:
- The Intervention Group: This group will take part in the 12-week health promotion program.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 80 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Has a prior diagnosis of any malignancy (cancer).
- •Has a diagnosed severe psychiatric or psychological disorder.
研究组 & 干预措施
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.
干预措施: Multi-component Health Promotion Lifestyle Intervention (Behavioral)
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).
干预措施: Standard Care (Other)
结局指标
主要结局
Score change in the Health Promotion Lifestyle Scale for High-Risk Colorectal Cancer Population (HPLP-HRCP)
时间窗: 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.
次要结局
- 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).)
- 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).)
研究者
Wenna Qian
Doctoral Researcher, School of Nursing, China Medical University
China Medical University, China