Colonoscopy vs Stool Testing for Older Adults With Colon Polyps
Purpose
This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.
Conditions
- Colorectal Polyp
- Colorectal Neoplasms
- Colorectal Adenoma
- Colorectal Cancer
- Digestive System Disease
Eligibility
- Eligible Ages
- Between 65 Years and 82 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- English or Spanish speaking - Personal history of colorectal polyps - Most recent colonoscopy with ≤2 non-advanced polyps - Currently due or coming due within 12 months for colonoscopy - Able to provide written informed consent
Exclusion Criteria
- Personal history of colorectal cancer - Personal history of genetic syndrome with high risk for colorectal cancer (e.g. Lynch Syndrome, Familial Adenomatous Polyposis Syndrome (FAP), or Serrated Polyposis Syndrome) - Personal history of inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) - Most recent colonoscopy with advanced polyp(s) or ≥3 non-advanced polyps - Patients unlikely to benefit from polyp surveillance (e.g., history of heart disease or coronary artery disease with treatment in the last 6 months, heart failure affecting function, lung disease requiring use of home oxygen, stroke within the last 4 months, dementia affecting activities of daily living (ADL) or instrumental activities of daily living (IADL), severe liver disease requiring the use of certain medications to control fluid, confusion, or bleeding, severe kidney disease requiring dialysis, or a new cancer diagnosis within the last year) - Patients unable to provide written informed consent
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator FIT |
FIT (annual) |
|
|
Active Comparator Colonoscopy |
Surveillance colonoscopy (one time) |
|
Recruiting Locations
Washington DC, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- Dartmouth-Hitchcock Medical Center
Detailed Description
Colon polyps are common among adults ≥50 years and people with colon polyps are recommended to undergo regular follow-up colonoscopy (surveillance) in hopes of preventing subsequent colorectal cancer (CRC). Older adults, particularly those who are age ≥70 years, most of whom have a history of only small colon polyps, may benefit little from repeated colonoscopies because of the increased risks of colonoscopy due to age and co-morbidities and potentially limited life expectancy due to other competing medical problems - CRC may never be a problem for them. Older adults may also be hesitant to get repeated colonoscopy because of the risk of complications (e.g., bleeding, perforation, etc.) and inconvenience. More surveillance options are needed to help address the concerns and challenges with repeated colonoscopies in older adults with a history of low-risk polyps. FIT is a noninvasive, stool-based test that is recommended and widely used in the US and globally for CRC screening in average-risk adults 45 to 75 years of age. In addition, FIT is already standard of care as a surveillance option for patients with a history of low-risk adenomas in Canada and has been shown to be equivalent to colonoscopy for screening of certain high-risk populations (e.g., those with a family history of CRC). However, FIT's role for surveillance among older adults who have a history of low-risk adenomas has not been studied in the US nor among older adults who may benefit from this noninvasive surveillance approach. The COOP Trial will fill this evidence gap and shed light on patient-, clinician-, and system-factors relevant to FIT for surveillance that together could potentially transform surveillance guidelines in the US and beyond The purpose of this study is to compare annual at-home stool-based testing, with a fecal immunochemical test (FIT), to colonoscopy in adults age 65-82 who have a history of colorectal polyps. The goal of the study is to compare how well FIT works compared to colonoscopy in looking for and finding colorectal cancer in older adults who have a history of colorectal polyps, as well as to understand people's experiences with using it compared to colonoscopy.