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

NCT06710860 | Not Yet Recruiting

• 1 other identifier: L2024SYSU-HL-054
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Colonoscopy; Colorectal Cancer; First-degree Relatives

Keywords

Colonoscopy; First-degree relatives; Cancer screening; Artificial intelligence; Speech technology; Type I hybrid effectiveness-implementation trial; RE-AIM framework

Outcome Measures

Primary Outcomes (1)

• Participate rate of CRC screening

  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.

  3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)

Secondary Outcomes (4)

• 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)

Other Outcomes (8)

• Participant characteristics

  Baseline (T0)

• Percentage of contacted FDRs who participate in this study

  Baseline (T0); 1 month post-intervention

• Enrollment routes

  Baseline (T0)

Study Arms (2)

Intervention group

EXPERIMENTAL

ScreenTalk AI-based tailored communication intervention

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

Attention control group

NO INTERVENTION

Targeted communication, attention control

Interventions

The intelligent voice-interactive tailored communication system-based intervention 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).

Intervention group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Related Publications (1)

• Lin S, Luo B, Cai L, Qiu L, Li H, Liu W, Luo Y, Yuan Y, Peng Z, Bai Y. Intelligent voice-interactive tailored communication system (ScreenTalk) to improve colorectal cancer screening uptake among first-degree relatives of colorectal cancer patients: study protocol for a cluster-randomised type I hybrid effectiveness-implementation trial. BMJ Open. 2025 Dec 10;15(12):e109534. doi: 10.1136/bmjopen-2025-109534.

  PMID: 41371735 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Yang Bai

CONTACT

+86 13922317606; baiy36@mail.sysu.edu.cn

Shuya Lin

CONTACT

+86 13715154981; linshy75@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)