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Enrolling by invitationNCT07503847Updated Mar 31, 2026

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

An interventional study of Colonoscopy and Shared Decision-Making in Colo-rectal Cancer, Shared Decision Making and Patient Decision Aid, sponsored by National Taiwan University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 40 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
2,286
Allocation
Randomized
Ages
40 Years to 49 Years
Sex
All
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Study 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).

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Conditions studied

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

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03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 2,286 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,286 participants (estimated)

Study arms

  • Experimental
    Shared Decision-Making

    Shared Decision-Making

    Behavioral: Shared Decision-Making

  • Active comparator
    Colonoscopy

    Colonoscopy

    Diagnostic Test: Colonoscopy

Interventions

  • Diagnostic testColonoscopy

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

  • BehavioralShared Decision-Making

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

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What researchers measure

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.

    Time frame: Within 3 months after randomization

Secondary outcomes

  1. 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.

    Time frame: Immediately after the SDM consultation visit

  2. 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.

    Time frame: Immediately after the intervention

  3. Detection rate of colorectal neoplasia

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

    Time frame: During colonoscopy procedure

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Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
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References and documents

Study documents

  • Study protocol · Oct 23, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07503847
Lead sponsor
National Taiwan University Hospital
Responsible party
National Taiwan University Clinical Trial Center (Principal Investigator, National Taiwan University Hospital) — Principal investigator
First posted
Mar 31, 2026
Start date
Sep 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 31, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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