Clinical trial NCT06710860: AI Assistant for Enhancing Colorectal Cancer Screening Among First-degree Relatives of Patients: a Randomized Trial
Official title: A Voice-activated AI Assistant (ScreenTalk AI) for Enhancing Colorectal Cancer Screening Among First-degree Relatives of Patients: a Randomized Type II Hybrid Effectiveness-implementation Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colonoscopy
Colorectal Cancer
First-degree Relatives
Keywords: Colonoscopy
First-degree relatives
Cancer screening
Artificial intelligence
Speech technology
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2024-11-29
Enrollment: 344
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Participants in intervention group will receive the ScreenTalk AI-based intervention consisting of 3 sessions: tailored messaging session, open dialogue session, and summary session. The primary outcome, screening uptake will be verified by medical records; and health belief will be measured at baseline, 3, 6 and 12 months.

Detailed description: ScreenTalk AI can automatically tailor screening recommendations based on risk and psychosocial characteristic assessments by leveraging AI-interactive speech technology. The three components of the ScreenTalk AI-based intervention are as follows: (1) tailored messaging session: to provide CRC risk and screening recommendation based on family history and health belief assessment; (2) open dialogue session: to communicate with users asking questions related to CRC risk and screening information, underpinned by the professional knowledge database and large language models; (3) summary session: to provide a picture overview for easy review. The evaluation will be guided by the RE-AIM. Quantitative measures will determine the reach, adoption, and implementation via participation rate, session adherence, completion, satisfaction rate, fidelity and cost. Screening uptake verified by medical records and health belief will be measured at baseline, 3, 6 and 12 months. Qualitative interviews will be conducted to identify the factors affecting implementation and maintenance.

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.

Primary outcomes:
measure: Uptake of screening
timeFrame: 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
Secondary outcomes:
measure: Perceived severity
timeFrame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
measure: Perceived susceptibility
timeFrame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
measure: Perceived benifits
timeFrame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
measure: Perceived barriers
timeFrame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
measure: Self-efficacy
timeFrame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
measure: Cue to action
timeFrame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
Other outcomes:
measure: Reach
timeFrame: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
measure: Adoption - staff level
timeFrame: Baseline (T0)
measure: Fidelity
timeFrame: 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
measure: Dosage
timeFrame: 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
measure: Adaptation
timeFrame: 12 months post-intervention (T3)
measure: Maintenance - individual level
timeFrame: 3 months post-intervention (T1); 6 months post-intervention (T2); 12 months post-intervention (T3)
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: