An Intelligent Voice-interactive Tailored Communication System (ScreenTalk) for Enhancing Colorectal Cancer Screening Among First-degree Relatives of Patients: a Randomized Type I Hybrid Effectiveness-implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 314
- 试验地点
- 3
- 主要终点
- Participate rate of CRC screening
研究概览
简要总结
Participants in intervention group will receive the ScreenTalk intervention consisting of 3 module: measurement module, algorithmic tailoring module, and open dialogue module. The primary outcome, CRC screening uptake will be verified by medical records; and health belief will be measured at baseline, 3, 6, 9 and 12 months.
详细描述
This study will follow a hybrid type I effectiveness-implementation trial design. A cluster-randomized controlled trial will be conducted to examine the effectiveness of the intelligent voice-interactive tailored communication system. ScreenTalk can automatically tailor screening recommendations based on risk and psychosocial characteristic assessments by leveraging intelligent speech interaction (ISI) technology. The three components of the ScreenTalk intervention are as follows: (1) a measurement module, (2) an algorithmic tailoring module, and (3) an open dialogue module. All participants will be required to complete 3 modules within 1 month. If the intervention group does not undergo CRC screening at the follow-up time point, the system will repeatedly provide tailored communication intervention to further enhance the CRC risk perception of FDRs based on the current evaluation results. The implementation outcomes will be guided by the RE-AIM framework. Both qualitative and quantitative methods will be employed to evaluate implementation outcomes and determine the factors that may influence implementation process. CRC screening uptake verified by medical records and health belief will be measured at baseline, 3, 6, 9 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40 to 75 years or 10 years before the age at which the relative was diagnosed;
- •individuals with one FDR with CRC age <60 years or with two or more FDRs with CRC at any age;
- •have not had a colonoscopy within 5 years;
- •access to WeChat themselves or through close family members living in the same household;
- •able to read and speak Chinese.
排除标准
- •Have history of cancer or inflammatory bowel disease;
- •have history of a hereditary syndromes (Lynch syndrome or familial adenomatous polyposis);
- •recently participate in another study or previously participated in cancer risk counseling or study;
- •with doctor-diagnosed psychiatric illness.
研究组 & 干预措施
Intervention group
ScreenTalk AI-based tailored communication intervention
干预措施: The intelligent voice-interactive tailored communication system-based intervention (Behavioral)
Attention control group
Targeted communication, attention control
结局指标
主要结局
Participate rate of CRC screening
时间窗: 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)
Uptake of colonoscopy or FOBT. Medical records will be collected from those who had undergone colonoscopy or fecal test. Only the examination records that are verified by medical records will be counted and involved in the data analysis.
次要结局
- Perceived threat(Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4))
- Perceived efficacy(Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4))
- Perceived barriers(Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4))
- Cue to action(Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4))
研究者
Yang Bai
Associate Professor
Sun Yat-sen University