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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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

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Colonoscopy Colorectal Cancer First-degree Relatives

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention group

ScreenTalk AI-based tailored communication intervention

Group Type EXPERIMENTAL

The intelligent voice-interactive tailored communication system-based intervention

Intervention Type BEHAVIORAL

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).

Attention control group

Targeted communication, attention control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes