Shared Decision-Making for Colorectal Cancer Screening in High-Risk First-Degree Relatives Aged 40-49

NCT07503847 | Enrolling By Invitation

• 1 other identifier: 202509053RINA
• Study Type: interventional
• Target: 2,286
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colo-rectal Cancer; Shared Decision Making; Patient Decision Aid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Patient satisfaction with shared decision-making

  Immediately after the SDM consultation visit

• Participant choice of screening modality (colonoscopy vs fecal immunochemical test)

  Immediately after the intervention

• Detection rate of colorectal neoplasia

  During colonoscopy procedure

Study Arms (2)

Shared Decision-Making

EXPERIMENTAL

Shared Decision-Making

Behavioral: Shared Decision-Making

Colonoscopy

ACTIVE COMPARATOR

Colonoscopy

Diagnostic Test: Colonoscopy

Interventions

Colonoscopy DIAGNOSTIC_TEST

Participants underwent standard colonoscopy performed by experienced endoscopists following routine clinical procedures.

Colonoscopy

Shared Decision-Making BEHAVIORAL

Participants received a shared decision-making intervention including educational materials and discussion with clinicians to choose between screening options.

Shared Decision-Making

Eligibility Criteria

• Age: 40 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 31, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)