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The primary objective of this study was to evaluate the impact of a constructed shared decision (SDM) intervention (offering an option between colonoscopy and immunochemical collapsible occult blood testing (fecal immunochemical test; FIT)) on improving the incidence of high colonoscopy stromal in patients aged 40-49 years with a close relative suffering from colorectal cancer, compared to standard care (direct referral for colonoscopy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared Decision-Making | Experimental | Shared Decision-Making |
|
| Colonoscopy | Active Comparator | Colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Diagnostic Test | Participants underwent standard colonoscopy performed by experienced endoscopists following routine clinical procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colonoscopy screening rate | Completion of colonoscopy within 3 months after randomization, defined as documented completion of colonoscopy or colonoscopy performed after a positive FIT result. | Within 3 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with shared decision-making | Measured using the Shared Decision-Making Questionnaire-9 (SDM-Q-9). The scale ranges from 0 to 100, with higher scores indicating greater decision conflict. | Immediately after the SDM consultation visit |
| Participant choice of screening modality (colonoscopy vs fecal immunochemical test) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2025 | Mar 13, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Shared Decision-Making | Behavioral | Participants received a shared decision-making intervention including educational materials and discussion with clinicians to choose between screening options. |
|
Participant choice of screening modality was recorded as either colonoscopy or fecal immunochemical test following the intervention. |
| Immediately after the intervention |
| Detection rate of colorectal neoplasia | Detection of colorectal neoplasia including adenoma, advanced adenoma, or colorectal cancer. | During colonoscopy procedure |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |