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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Colo-rectal Cancer; Shared Decision Making; Patient Decision Aid
• Intervention / Treatment: Behavioral: Shared Decision-Making; Diagnostic test: Colonoscopy

• Study Type: Interventional
• Enrollment (Estimated): 2286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared Decision-Making	Behavioral: Shared Decision-Making; Participants received a shared decision-making intervention including educational materials and discussion with clinicians to choose between screening options.
Active Comparator: Colonoscopy	Diagnostic test: Colonoscopy; Participants underwent standard colonoscopy performed by experienced endoscopists following routine clinical procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Colonoscopy
• Other Study ID Numbers: 202509053RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No