RECRUITING

Surveillance Colonoscopy in Older Adults: The SurvOlderAdults Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Colorectal cancer is a leading cause of cancer death. Detection and removal of polyps can reduce risk for developing colorectal cancer. After finding and removing precancerous polyps, repeat colonoscopy is routinely recommended. However, it is unclear whether repeat additional colonoscopy further reduces risk for colorectal cancer. For older adults age 75 and older, the lack of this information is especially important, given that the risks of colonoscopy go up with age. This research will evaluate whether older adults with a prior history of precancerous polyps have higher colorectal cancer risks compared to older adults who had a prior normal colonoscopy, and whether, among those with prior precancerous polyps, repeating a colonoscopy after age 75 is associated with reduced cancer risk. The investigators will synthesize these data and gather perspectives from Veterans and clinical stakeholders to make recommendations on whether older adults with a prior history of polyps should continue or defer colonoscopy after age 75.

Official Title

Surveillance Colonoscopy in Older Adults: The SurvOlderAdults Study

Quick Facts

Study Start:2023-10-01

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05994482

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* The study base will consist of any Veteran alive at age 75 between 2005-2019, with exposure to a qualifying colonoscopy in the 10-year period prior to turning age 75 * The investigators will include those with a qualifying colonoscopy associated with a colonoscopy note that can be processed by the previously established natural language processing (NLP) pipelines for extracting colonoscopy data from free-text reports60, 61 (see prior work below) * The colonoscopy done closest to, but prior to age 75 will be considered as a candidate qualifying colonoscopy * Date of cohort entry (start of follow up) will be defined as date at which a participant meeting inclusion criteria turned 75 * Date of qualifying colonoscopy prior to age 75 will be defined as the qualifying colonoscopy reference date * The study base for Aim 2 consists of Veterans ages 75 and alive between 2003-2019 who had a polypectomy prior to turning age 75 * Identification of the study base for Aim 2 will take a distinct approach from Aim 1 * A candidate qualifying colonoscopy event will be defined by presence of a CPT code for colonoscopy associated with a pathology note-based diagnosis of an adenoma within 30 days of the CPT code for colonoscopy * The colonoscopy event occurring closest to, but prior to age 75 will be selected * From the study base, all individuals who developed incident or fatal CRC, and a random sample of the entire study base will undergo manual EHR chart review to confirm study eligibility * To identify candidate incident CRC cases, the investigators will identify all adults with a CRC diagnosis at ages 75, utilizing the Oncology Domain with the same strategy for incident CRC identification as described for Aim 1 * To identify candidate fatal CRC cases, the investigators will identify all adults with a fatal CRC diagnosis at ages 75, using NDI cause-specific mortality data * To identify candidate members of the subcohort for chart review, a random sample of the study base will be drawn * This sample may include Veterans with and without subsequent CRC. Rationale for including Veterans with and without subsequent CRC (incident and/or fatal) in the control subcohort is well established * Specifically, if the investigators were to conduct a cohort study without sampling, then at the start of follow up, the cohort would include people with subsequent CRC * In a traditional cohort study, every CRC case contributes to the denominator of individuals at risk. Thus, by including in the subcohort Veterans with and without CRC on follow up, the investigators are able to calculate risk based on exposure to surveillance as if the investigators had conducted a cohort study utilizing the entire cohort * The investigators will use EHR data to generate a list of VASDHS and VAGLA patients who have: * a) age 75 * b) history of colonoscopy with polypectomy in the past 10 years * c) been referred for surveillance colonoscopy * The investigators will randomly select patients, recruiting until the investigators have 12 who completed surveillance colonoscopy and 12 who have not completed surveillance * The investigators will monitor the sample to assure sex balance consistent with VA demographics for patients who have had colonoscopy (98.2% male and 1.8% females age 75) * The investigators will also ensure that at least one- third of sampled patients have moderate or severe frailty based on the claims-based VA-FI36, 64 and make efforts to maintain patient racial/ethnic and geographic (i.e. San Diego/Los Angeles areas) diversity * The investigators will conduct interviews with 20 providers, specifically 10 primary care providers (including 3-4 geriatricians) and 10 gastroenterologists * The investigators will select providers from a randomly generated list of practicing VA clinicians (5/8th or greater) at VASDHS or VAGLA * If the investigators experience challenges reaching the target sample size, the investigators will employ snowball sampling by asking participants to name other potentially eligible clinicians * The investigators anticipate reaching thematic saturation given \> 17 interviews in each group and have made provisions to accommodate up to 6 additional patient and/or provider interviews if new themes continue to arise by the end of the planned interviews * The investigators will make efforts to achieve geographic balance to ensure provider representation from VASDHS and VAGLA * The investigators will convene a group of 15-20 multi-level stakeholders for the in-person expert panel in Quarter 1 of Year 4 * The panel will include VA patients and caregivers (not included in Aim 3a): * VA providers * VA leadership and policymakers * health services and clinical researchers * individuals with non-VA healthcare systems perspectives	* History of CRC prior to age 75 * History of sessile serrated adenoma/polyp/lesion (SSL), traditional serrated adenoma (TSA), or large serrated polyp (LSP, defined as hyperplastic polyp \>10mm) at qualifying colonoscopy * History of inflammatory bowel disease (IBD) prior to age 75 * Absence of exposure to normal colonoscopy or colonoscopy with polypectomy between ages 65-75 * All candidate CRC cases and members for the subcohort will be included in the analytic sample unless they meet one of the following

Inclusion Criteria

Exclusion Criteria

* The study base will consist of any Veteran alive at age 75 between 2005-2019, with exposure to a qualifying colonoscopy in the 10-year period prior to turning age 75
* The investigators will include those with a qualifying colonoscopy associated with a colonoscopy note that can be processed by the previously established natural language processing (NLP) pipelines for extracting colonoscopy data from free-text reports60, 61 (see prior work below)
* The colonoscopy done closest to, but prior to age 75 will be considered as a candidate qualifying colonoscopy
* Date of cohort entry (start of follow up) will be defined as date at which a participant meeting inclusion criteria turned 75
* Date of qualifying colonoscopy prior to age 75 will be defined as the qualifying colonoscopy reference date
* The study base for Aim 2 consists of Veterans ages 75 and alive between 2003-2019 who had a polypectomy prior to turning age 75
* Identification of the study base for Aim 2 will take a distinct approach from Aim 1
* A candidate qualifying colonoscopy event will be defined by presence of a CPT code for colonoscopy associated with a pathology note-based diagnosis of an adenoma within 30 days of the CPT code for colonoscopy
* The colonoscopy event occurring closest to, but prior to age 75 will be selected
* From the study base, all individuals who developed incident or fatal CRC, and a random sample of the entire study base will undergo manual EHR chart review to confirm study eligibility
* To identify candidate incident CRC cases, the investigators will identify all adults with a CRC diagnosis at ages 75, utilizing the Oncology Domain with the same strategy for incident CRC identification as described for Aim 1
* To identify candidate fatal CRC cases, the investigators will identify all adults with a fatal CRC diagnosis at ages 75, using NDI cause-specific mortality data
* To identify candidate members of the subcohort for chart review, a random sample of the study base will be drawn
* This sample may include Veterans with and without subsequent CRC. Rationale for including Veterans with and without subsequent CRC (incident and/or fatal) in the control subcohort is well established
* Specifically, if the investigators were to conduct a cohort study without sampling, then at the start of follow up, the cohort would include people with subsequent CRC
* In a traditional cohort study, every CRC case contributes to the denominator of individuals at risk. Thus, by including in the subcohort Veterans with and without CRC on follow up, the investigators are able to calculate risk based on exposure to surveillance as if the investigators had conducted a cohort study utilizing the entire cohort
* The investigators will use EHR data to generate a list of VASDHS and VAGLA patients who have:
* a) age 75
* b) history of colonoscopy with polypectomy in the past 10 years
* c) been referred for surveillance colonoscopy
* The investigators will randomly select patients, recruiting until the investigators have 12 who completed surveillance colonoscopy and 12 who have not completed surveillance
* The investigators will monitor the sample to assure sex balance consistent with VA demographics for patients who have had colonoscopy (98.2% male and 1.8% females age 75)
* The investigators will also ensure that at least one- third of sampled patients have moderate or severe frailty based on the claims-based VA-FI36, 64 and make efforts to maintain patient racial/ethnic and geographic (i.e. San Diego/Los Angeles areas) diversity
* The investigators will conduct interviews with 20 providers, specifically 10 primary care providers (including 3-4 geriatricians) and 10 gastroenterologists
* The investigators will select providers from a randomly generated list of practicing VA clinicians (5/8th or greater) at VASDHS or VAGLA
* If the investigators experience challenges reaching the target sample size, the investigators will employ snowball sampling by asking participants to name other potentially eligible clinicians
* The investigators anticipate reaching thematic saturation given \> 17 interviews in each group and have made provisions to accommodate up to 6 additional patient and/or provider interviews if new themes continue to arise by the end of the planned interviews
* The investigators will make efforts to achieve geographic balance to ensure provider representation from VASDHS and VAGLA
* The investigators will convene a group of 15-20 multi-level stakeholders for the in-person expert panel in Quarter 1 of Year 4
* The panel will include VA patients and caregivers (not included in Aim 3a):
* VA providers
* VA leadership and policymakers
* health services and clinical researchers
* individuals with non-VA healthcare systems perspectives

* History of CRC prior to age 75
* History of sessile serrated adenoma/polyp/lesion (SSL), traditional serrated adenoma (TSA), or large serrated polyp (LSP, defined as hyperplastic polyp \>10mm) at qualifying colonoscopy
* History of inflammatory bowel disease (IBD) prior to age 75
* Absence of exposure to normal colonoscopy or colonoscopy with polypectomy between ages 65-75
* All candidate CRC cases and members for the subcohort will be included in the analytic sample unless they meet one of the following

Contacts and Locations

Study Contact

Samir Gupta, MD MS

CONTACT

(858) 552-8585

samir.gupta@va.gov

Principal Investigator

Samir Gupta, MD MS

PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Folasade Popoola May, MD MSPH PhD

PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002

United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Samir Gupta, MD MS, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA
Folasade Popoola May, MD MSPH PhD, PRINCIPAL_INVESTIGATOR, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-10-01

Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

colorectal cancer
older adults
aging

Additional Relevant MeSH Terms

Colorectal Cancer