Clinical trial NCT05612347: Colonoscopy vs Stool Testing for Older Adults With Colon Polyps
Official title: Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Polyp
Colorectal Neoplasms
Colorectal Adenoma
Colorectal Cancer
Digestive System Disease
Keywords: Colonoscopy
Fecal immunochemical test (FIT)
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-11-10
Enrollment: 8946
Sex: ALL
Minimum age (years): 65
Maximum age (years): 82
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of advanced neoplasia in each study group, annual FIT and colonoscopy, assessed by comparing the detection of advanced neoplasia between the two study groups.
timeFrame: Up to 11 years
Secondary outcomes:
measure: Change from baseline Satisfaction and Trust of colorectal screening testing assessed by Tiro et al (2005) Response Efficacy sub-scale from the general colorectal cancer screening survey.
timeFrame: Baseline, 1 year after surveillance colonoscopy, annually after each completed FIT for up to 6 years
measure: Change from baseline worry about colorectal Cancer assessed by the Cancer Worry Scale (CWS)
timeFrame: Baseline and annually for up to 6 years
measure: Change from baseline Perceived colorectal cancer susceptibility using Absolute perceived susceptibility to colorectal polyps subscale from McQueen (2010)
timeFrame: Baseline, annually for up to 6 years
measure: Change from baseline Emotional benefit of surveillance assessed by a modified version of the Psychological Consequences Questionnaire (PCQ)
timeFrame: Baseline and annually for up to 6 years
measure: Change from baseline perceived global health assessed by the Patient-Reported Outcomes Measurement Information System-Global 10
timeFrame: Baseline and annually for up to 6 years
measure: Major and minor harms within 30 days of colonoscopy, as measured through chart review and telephone interview.
timeFrame: 30-45 days post colonoscopy for up to 6 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Walnut Creek
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Washington DC
country: United States
facility: MedStar Health
state: District of Columbia
city: Tampa
country: United States
facility: James A. Haley Veterans Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates
state: Illinois
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Health
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth Health
state: New Hampshire
city: New York
country: United States
facility: New York Harbor Health Care System - Dept of Veterans Affairs
state: New York
city: Portand
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University (Knight Cancer Institute)
state: Oregon
city: Charlottesville
country: United States
facility: University of Virginia Health
state: Virginia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Audrey H Calderwood, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permante Northern California
name: Theodore R Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.
citation: Dubé C, McCurdy BR, Bronstein T, et al. ColonCancerCheck Recommendations for Post-Polypectomy Surveillance, 2019. Available at: https://www.cancercareontario.ca/en/content/coloncancercheck-recommendations-post-polypectomy-surveillance
citation: Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
citation: Kothari ST, Huang RJ, Shaukat A, Agrawal D, Buxbaum JL, Abbas Fehmi SM, Fishman DS, Gurudu SR, Khashab MA, Jamil LH, Jue TL, Law JK, Lee JK, Naveed M, Qumseya BJ, Sawhney MS, Thosani N, Yang J, DeWitt JM, Wani S; ASGE Standards of Practice Committee Chair. ASGE review of adverse events in colonoscopy. Gastrointest Endosc. 2019 Dec;90(6):863-876.e33. doi: 10.1016/j.gie.2019.07.033. Epub 2019 Sep 25.
citation: Warren JL, Klabunde CN, Mariotto AB, Meekins A, Topor M, Brown ML, Ransohoff DF. Adverse events after outpatient colonoscopy in the Medicare population. Ann Intern Med. 2009 Jun 16;150(12):849-57, W152. doi: 10.7326/0003-4819-150-12-200906160-00008.