NCT06710860

ScreenTalk to Improve Colorectal Cancer Screening Uptake Among First-degree Relatives of Patients: a Study Protocol

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Colonoscopy
• Colorectal Cancer
• First-degree Relatives

Interventions

Type	Name	Description
BEHAVIORAL	The intelligent voice-interactive tailored communication system-based intervention	Participants in intervention group will receive the ScreenTalk intervention consisting of 3 modules:(1) a measurement module, (2) an algorithmic tailoring module, and (3) an open di-alogue 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 primary outcome (uptake of CRC screening) will be measured at 3 months post-intervention (T1), 6 months post-intervention (T2), 9 months post-intervention (T3) and 12 months post-intervention (T4).

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-11-29
• Last updated: 2025-07-15

Locations

3 sites across 1 country: China