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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | ScreenTalk AI-based tailored communication intervention |
|
| Attention control group | No Intervention | Targeted communication, attention control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived threat | The Colorectal Cancer and Colonoscopy Screening Health Beliefs Scale for First-Degree Relatives (CCHBS-FDR), with 6 dimensions, will be used to measures perceived threat of CRC and colonoscopy screening, namely per-ceived susceptibility of CRC and perceived severity of CRC. Each item of CCHBS-FDR is rated on a five-point (1-5) Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with scores ranging from 36 to 180. Higher scores on each dimension indicate higher levels of perception. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant characteristics | A self-designed general information questionnaire will be used to collect participant characteristics. | Baseline (T0) |
| Percentage of contacted FDRs who participate in this study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Bai | Contact | +86 13922317606 | baiy36@mail.sysu.edu.cn | |
| Shuya Lin | Contact | +86 13715154981 | linshy75@mail2.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41371735 | Derived | 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. |
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| Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4) |
| Perceived efficacy | Perceived efficacy includes perceived benefits and self-efficacy. The Colorectal Cancer and Colonoscopy Screening Health Beliefs Scale for First-Degree Relatives (CCHBS-FDR) will be used to measures perceived efficacy of colonoscopy screening, and the four-item simplified Chinese version of the self-efficacy questionnaire will be used to assess the self-efficacy for participating in CRC screening. Each item of these two questionnaires is rated on a five-point (1-5) Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with scores ranging from 36 to 180. Higher scores on each dimension indicate higher levels of perception. | Baseline (T0); 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4) |
| Perceived barriers | The Colorectal Cancer and Colonoscopy Screening Health Beliefs Scale for First-Degree Relatives (CCHBS-FDR) will be used to measures perceived barriers for participating in CRC screening. Each item of CCHBS-FDR is rated on a five-point (1-5) Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with scores ranging from 36 to 180. Higher scores on each dimension indicate higher levels of perception. | 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 | Including three types of action cues: family history of CRC, physician's recommendation and health insurance coverage. The cue to action for CRC screening questionnaire will be used to collect information of cue to action among FDRs. Each item is rated on a five-point (1-5) Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The score for cues to action was calculated by averaging the corresponding items (ranging from 1 to 5), with higher score indi-cating higher 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) |
Collect data through information recorded in the Implementation logbook
| Baseline (T0); 1 month post-intervention |
| Enrollment routes | Including the recruitment approach and reasons for refusal to participate. It will be collected through the implementation logbook. | Baseline (T0) |
| Representativeness of staff that participate | The self-designed general information questionnaire for staff will be used to collect related data. | Baseline (T0) |
| Barriers and facilitators to adoption | Qualitative interviews will be conducted to gain staff insights into intervention adoption. | 13 months post-intervention |
| Fidelity | Fidelity includes participants' adherence of each module and reasons for non-completion. Relevant data will be collected through the tailored communication system record. | 1 month post-intervention; post-implementation |
| Acceptability | The User Feedback Questionnaire for ScreenTalk will be used to measure the satisfaction among the participant for ScreenTalk. | 1-month post intervention |
| Maintenance | Sustained engagement of participants at 3-month, 6-month, 9-month, and 12-month follow-up. Follow-up information of participants will be obtained through the implementation logbook and tailored communication system record. | 3 months post-intervention (T1); 6 months post-intervention (T2); 9 months post-intervention (T3); 12 months post-intervention (T4) |
| Sun Yat-sen Memorial Hospital | Guangzhou | Guangdong | 510120 | China |
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
|
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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