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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Participate rate of CRC screening [Срок оценки: 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)]

Вторичные конечные точки (4)

• Perceived threat [Срок оценки: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)]
• Perceived efficacy [Срок оценки: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)]
• Perceived barriers [Срок оценки: 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 [Срок оценки: Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Китай · 3 центра

• Sun Yat-sen University Cancer Center — Гуанчжоу
• Sun Yat-sen Memorial Hospital — Гуанчжоу
• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Публикации

• 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

Идентификаторы

NCT: NCT06710860 · L2024SYSU-HL-054

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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