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Enrolling by Invitation

NCT Number: NCT07503847

Shared Decision-Making for Colorectal Cancer Screening in 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).

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Patient Decision Aid Shared Decision Making

Age range

40 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colonoscopy

Diagnostic Test

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

Shared Decision-Making

Behavioral

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

Primary outcomes

  1. Colonoscopy screening rate

    Time frame: Within 3 months after randomization

    Completion of colonoscopy within 3 months after randomization, defined as documented completion of colonoscopy or colonoscopy performed after a positive FIT result.

Secondary outcomes

  1. Patient satisfaction with shared decision-making

    Time frame: Immediately after the SDM consultation visit

    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.

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

    Time frame: Immediately after the intervention

    Participant choice of screening modality was recorded as either colonoscopy or fecal immunochemical test following the intervention.

  3. Detection rate of colorectal neoplasia

    Time frame: During colonoscopy procedure

    Detection of colorectal neoplasia including adenoma, advanced adenoma, or colorectal cancer.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial on Shared Decision-Making for Colorectal Cancer Screening Among High-Risk First-Degree Relatives Aged 40-49

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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