ScreenTalk to Improve Colorectal Cancer Screening Uptake Among First-degree Relatives of Patients: a Study Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The intelligent voice-interactive tailored communication system-based intervention.
- Who it may be relevant to
- Registry conditions: Colonoscopy, Colorectal Cancer, First-degree Relatives. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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 ev
Primary outcome measures
- Participate rate of CRC screening [Time frame: 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)]
Secondary outcome measures (4)
- Perceived threat [Time frame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)]
- Perceived efficacy [Time frame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)]
- Perceived barriers [Time frame: 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 [Time frame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
China · 3 centers
- Sun Yat-sen University Cancer Center — Guangzhou
- Sun Yat-sen Memorial Hospital — Guangzhou
- The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
Publications
- 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-2 PMID 41371735
Identifiers
NCT: NCT06710860 · L2024SYSU-HL-054