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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Not yet enrolling

Conditions

First-degree Relatives
Colonoscopy
Colorectal Cancer

Treatments

Behavioral: The intelligent voice-interactive tailored communication system-based intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06710860
L2024SYSU-HL-054

Details and patient eligibility

About

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.

Full 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.

Enrollment

314 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

314 participants in 2 patient groups

Intervention group
Experimental group
Description:
ScreenTalk AI-based tailored communication intervention
Treatment:
Behavioral: The intelligent voice-interactive tailored communication system-based intervention
Attention control group
No Intervention group
Description:
Targeted communication, attention control

Trial contacts and locations

3

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Central trial contact

Shuya Lin; Yang Bai

Data sourced from clinicaltrials.gov

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