Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps
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.
Arms & interventions
- Diagnostic TestFIT
Annual FIT
- Diagnostic TestColonoscopy
One time surveillance colonoscopy
Outcome measures
Primary
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.
The investigators will determine the incidence of advanced neoplasia, defined as adenocarcinoma of the colon or rectum or adenomas or serrated polyps ≥1 cm in size or with villous features or any dysplasia, or traditional serrated polyps, in both study groups through annual surveys asking about any changes in polyp history or new cancer diagnosis for up to 6 years and medical record review for up to 11 years. The incidence of advanced neoplasia will be compared between the two study group cumulatively after all the data has been collected.
Time frame: Up to 11 years
Secondary
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.
Time frame: Baseline, 1 year after surveillance colonoscopy, annually after each completed FIT for up to 6 years
Change from baseline worry about colorectal Cancer assessed by the Cancer Worry Scale (CWS)
Time frame: Baseline and annually for up to 6 years
Change from baseline Perceived colorectal cancer susceptibility using Absolute perceived susceptibility to colorectal polyps subscale from McQueen (2010)
Time frame: Baseline, annually for up to 6 years
Change from baseline Emotional benefit of surveillance assessed by a modified version of the Psychological Consequences Questionnaire (PCQ)
Time frame: Baseline and annually for up to 6 years
Change from baseline perceived global health assessed by the Patient-Reported Outcomes Measurement Information System-Global 10
Time frame: Baseline and annually for up to 6 years
Major and minor harms within 30 days of colonoscopy, as measured through chart review and telephone interview.
Time frame: 30-45 days post colonoscopy for up to 6 years
Eligibility criteria
Study locations (18)
University of Alabama Birmingham
Birmingham, Alabama, 35233
University of Arizona
Tucson, Arizona, 85719
Jennifer Moreno Department of Veterans Affairs Medical Cneter
San Diego, California, 92161
Kaiser Permanente Northern California
Walnut Creek, California, 94596
University of Colorado
Aurora, Colorado, 80045
MedStar Health
Washington D.C., District of Columbia, 20010
James A. Haley Veterans Hospital
Tampa, Florida, 33612-4745
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, 46202
University of Michigan Health
Ann Arbor, Michigan, 48105
Henry Ford
Detroit, Michigan, 48202
Dartmouth Health
Lebanon, New Hampshire, 03756
New York Harbor Health Care System - Dept of Veterans Affairs
New York, New York, 10010
Kaiser Permanente Northwest
Portand, Oregon, 97232
Oregon Health & Science University (Knight Cancer Institute)
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84112
Intermountain Health
Sandy City, Utah, 84094
University of Virginia Health
Charlottesville, Virginia, 22903
References
- 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.(PubMed)
- 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
- 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.(PubMed)
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