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

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National Taiwan University

Status

Invitation-only

Conditions

Patient Decision Aid
Shared Decision Making
Colo-rectal Cancer

Treatments

Diagnostic Test: Colonoscopy
Behavioral: Shared Decision-Making

Study type

Interventional

Funder types

Other

Identifiers

NCT07503847
202509053RINA

Details and patient eligibility

About

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).

Enrollment

2,286 estimated patients

Sex

All

Ages

40 to 49 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,286 participants in 2 patient groups

Shared Decision-Making
Experimental group
Description:
Shared Decision-Making
Treatment:
Behavioral: Shared Decision-Making
Colonoscopy
Active Comparator group
Description:
Colonoscopy
Treatment:
Diagnostic Test: Colonoscopy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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