Colo-rectal CancerNCT07503847
Shared Decision-Making for Colorectal Cancer Screening in High-Risk First-Degree Relatives Aged 40-49
A study testing Colonoscopy and Shared Decision-Making in people with Colo-rectal Cancer and Shared Decision Making, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 49 years
- Conditions the study is for
- Colo-rectal Cancer, Shared Decision Making, Patient Decision Aid
- What is being tested?
- Colonoscopy and Shared Decision-Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,286 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Being tested
- Colonoscopy, Shared Decision-Making
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDiagnostic test
Participants underwent standard colonoscopy performed by experienced endoscopists following routine clinical procedures.
Shared Decision-MakingBehavioural
Participants received a shared decision-making intervention including educational materials and discussion with clinicians to choose between screening options.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision-Making | Experimental | Shared Decision-Making Receives: Behavioral: Shared Decision-Making |
| Colonoscopy | Active comparator | Colonoscopy Receives: Diagnostic Test: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months after randomization
Secondary outcomes (3)
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.
Measured: 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.
Measured: Immediately after the intervention
Detection rate of colorectal neoplasia
Detection of colorectal neoplasia including adenoma, advanced adenoma, or colorectal cancer.
Measured: During colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503847
- Sponsor's protocol ID
- 202509053RINA
- Status last verified
- Nov 2025
- First submitted
- 10 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Shared Decision-Making for Colorectal Cancer Screening Among High-Risk First-Degree Relatives Aged 40-49
- ClinicalTrials.gov ID
- NCT07503847
- Acronym / sponsor ID
- 202509053RINA
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,286 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Decision-Making | Experimental | Behavioral: Shared Decision-MakingShared Decision-Making |
| Colonoscopy | Active comparator | Diagnostic Test: ColonoscopyColonoscopy |
Who may qualify
- Ages
- 40 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyParticipants underwent standard colonoscopy performed by experienced endoscopists following routine clinical procedures. | Diagnostic test | Colonoscopy |
| Shared Decision-MakingParticipants received a shared decision-making intervention including educational materials and discussion with clinicians to choose between screening options. | Behavioural | Shared Decision-Making |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy and Shared Decision-Making in people with Colo-rectal Cancer and Shared Decision Making, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonoscopy screening rate (time frame: Within 3 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.