COOP: Colonoscopy vs Stool Testing for Older Adults Colon Polyps

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05612347

Collaborator

Patient-Centered Outcomes Research Institute (Other)

8,946

Enrollment

Locations

Arms

131

Anticipated Duration (Months)

1789.2

Patients Per Site

13.7

Patients Per Site Per Month

Study Details

Study Description

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 70-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Polyp Colorectal Neoplasms Colorectal Adenoma Colorectal Cancer Digestive System Disease	Diagnostic Test: FIT Diagnostic Test: Colonoscopy	N/A

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 70-82 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8946 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2033

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FIT FIT (annual)	Diagnostic Test: FIT Annual FIT
Active Comparator: Colonoscopy Surveillance colonoscopy (one time)	Diagnostic Test: Colonoscopy One time surveillance colonoscopy

Arm

Intervention/Treatment

Active Comparator: FIT

FIT (annual)

Diagnostic Test: FIT

Annual FIT

Active Comparator: Colonoscopy

Surveillance colonoscopy (one time)

Diagnostic Test: Colonoscopy

One time surveillance colonoscopy

Outcome Measures

Primary Outcome Measures

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. [Up to 11 years]
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.

Secondary Outcome Measures

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. [Baseline, 1 year after surveillance colonoscopy, annually after each completed FIT for up to 6 years]
The Response Efficacy sub-scale from the general colorectal cancer screening survey is a 2 item scale with five response options (1=strongly disagree, 2=mildly disagree, 3=don't know, 4=mildly agree, 5=strongly agree), such that each individual attains a score ranging from 2 to 10.
Change from baseline worry about colorectal Cancer assessed by the Cancer Worry Scale (CWS) [Baseline and annually for up to 6 years]
The Cancer Worry Scale is a six-item scale designed to measure worry about the risk of developing cancer and the impact of worry on daily functioning. The scale consists of six questions with four response options (1 = not at all or rarely; 2 = sometimes; 3 = often; 4 = almost all the time), such that each individual attains a score ranging from 6 (minimum worry) to 24 (maximum worry).
Change from baseline Perceived colorectal cancer susceptibility using Absolute perceived susceptibility to colorectal polyps subscale from McQueen (2010) [Baseline, annually for up to 6 years]
The absolute perceived susceptibility to colorectal polyps subscale from McQueen (2010) is a three-question scale using four-point Likert format ranging from 1= strongly disagree to 4=strongly agree, such that each individual attains a score ranging from 3 (minimum susceptibility) to 12 (maximum susceptibility).
Change from baseline Emotional benefit of surveillance assessed by a modified version of the Psychological Consequences Questionnaire (PCQ) [Baseline and annually for up to 6 years]
The PCQ is a 22 question scale that has four response options (1=Not at all, 2=a little bit, 3=quite a bit, 4=a great deal) such that each individual attains a score ranging from 22 to 88.
Change from baseline perceived global health assessed by the Patient-Reported Outcomes Measurement Information System-Global 10 [Baseline and annually for up to 6 years]
The Patient-Reported Outcomes Measurement Information System-10 is a 10-item scale that has five response options (5=excellent, 4=very good, 3=good, 2=fair, 1=poor) which assess overall QOL. Raw scores are transformed into T scores; higher T scores indicate greater endorsement of the construct being assessed. Scoring supports two summary scores: A Global Physical Health (GPH) score and a Global Mental Health (GMH) score.
Major and minor harms within 30 days of colonoscopy, as measured through chart review and telephone interview. [30-45 days post colonoscopy for up to 6 years]
Major and minor harms within 30 days of colonoscopy will be collected through chart review and a telephone interview with participants 30-45 post study surveillance colonoscopy or study colonoscopy for positive FIT. The incidence of harms will be compared between the study groups (annual FIT and colonoscopy).

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years to 82 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 ADLs or IADLs, 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 with an existing, scheduled appointment for surveillance colonoscopy
Patients unable to provide written informed consent
Patients who lack a valid mailing address

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Birmingham	Birmingham	Alabama	United States	35233
2	Kaiser Permanente Northern California	Walnut Creek	California	United States	94596
3	University of Colorado	Aurora	Colorado	United States	80045
4	Dartmouth Health	Lebanon	New Hampshire	United States	03756
5	Kaiser Permanente Northwest	Portland	Oregon	United States	97232

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center
Patient-Centered Outcomes Research Institute

Investigators

Principal Investigator: Audrey H Calderwood, MD, MS, Dartmouth-Hitchcock Medical Center
Principal Investigator: Theodore R Levin, MD, Kaiser Permante Northern California