Colo-rectal Cancer, Patient Decision Aid, Shared Decision Making
Conditions
Brief 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).
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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 49 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colonoscopy screening rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with shared decision-making | 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. |
| Participant choice of screening modality (colonoscopy vs fecal immunochemical test) | Immediately after the intervention | Participant choice of screening modality was recorded as either colonoscopy or fecal immunochemical test following the intervention. |
| Detection rate of colorectal neoplasia | During colonoscopy procedure | Detection of colorectal neoplasia including adenoma, advanced adenoma, or colorectal cancer. |
Countries
Taiwan
Outcome results
None listed