Shared Decision-Making for Colorectal Cancer Screening in High-Risk First-Degree Relatives Aged 40-49
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Colonoscopy, Shared Decision-Making.
- Who it may be relevant to
- Registry conditions: Colo-rectal Cancer, Shared Decision Making, Patient Decision Aid. Basic parameters: 40 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial on Shared Decision-Making for Colorectal Cancer Screening Among High-Risk First-Degree Relatives Aged 40-49
Overview
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).
Interventions
- Diagnostic test Colonoscopy
Participants underwent standard colonoscopy performed by experienced endoscopists following routine clinical procedures. - Behavioral Shared Decision-Making
Participants received a shared decision-making intervention including educational materials and discussion with clinicians to choose between screening options.
Primary outcome measures
- Colonoscopy screening rate [Time frame: Within 3 months after randomization]
Secondary outcome measures (3)
- Patient satisfaction with shared decision-making [Time frame: Immediately after the SDM consultation visit]
- Participant choice of screening modality (colonoscopy vs fecal immunochemical test) [Time frame: Immediately after the intervention]
- Detection rate of colorectal neoplasia [Time frame: During colonoscopy procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT07503847 · 202509053RINA