Clinical trial · Interventional
Shared Decision-Making for Colorectal Cancer Screening in High-Risk First-Degree Relatives Aged 40-49
A Randomized Controlled Trial on Shared Decision-Making for Colorectal Cancer Screening Among High-Risk First-Degree Relatives Aged 40-49
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | Colon Neoplasm | PROBABILISTIC | 0.70 |
| Patient Decision Aid | — | UNRESOLVED | — |
| Shared Decision Making | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Diagnostic Test | — | UNRESOLVED |
| Shared Decision-Making | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Shared Decision-Making
- description
- Shared Decision-Making
- interventionNames
- Behavioral: Shared Decision-Making
- type
- ACTIVE_COMPARATOR
- label
- Colonoscopy
- description
- Colonoscopy
- interventionNames
- Diagnostic Test: Colonoscopy
Primary outcomes (1)
- measure
- Colonoscopy screening rate
- timeFrame
- Within 3 months after randomization
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * Age 40 to 49 years at the time of recruitment. * At least one immediate family member (biological parent, sibling, or child) has been pathologically diagnosed with colorectal cancer. * Able to read, understand, and provide prior consent. * Willing to be randomly assigned to any research group and complete all research procedures. Exclusion Criteria: * A personal history of colorectal cancer or inflammatory bowel disease (Crohn's disease or ulcerative colitis). * Presence of warning signs of colorectal cancer requiring diagnostic evaluation rather than screening (e.g., unexplained rectal bleeding, significant involuntary weight loss, persistent changes in bowel habits). * Presence of comorbidities that may contraindicate colonoscopy. * Having undergone colonoscopy within the past three years. * Inability to read, understand, and provide written informed consent.
References
Publications (0)
Data not yet available