Trial Title:
Surveillance Colonoscopy in Older Adults: The SurvOlderAdults Study
NCT ID:
NCT05994482
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer
older adults
aging
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
adenoma vs no adenoma
Description:
For Aim 1, the investigators will examine colorectal cancer risk among older adults with
prior removal of a precancerous polyp (adenoma) vs a prior normal colonoscopy
Arm group label:
Older adults
Intervention type:
Other
Intervention name:
colonoscopy vs no colonoscopy
Description:
For Aim 2, the investigators will examine colorectal cancer risk among older adults with
prior history of polypectomy, exposed vs unexposed to subsequent surveillance colonoscopy
Arm group label:
Older adults with prior polypectomy
Intervention type:
Other
Intervention name:
survey and expert panel
Description:
The investigators will conduct 44 semi-structured one-on-one qualitative interviews with
VA patients (older adults) and providers (primary care, GI, geriatrics) to understand
perspectives on CRC risk, and potential benefits and harms of surveillance (Aim 3a). The
investigators will then convene an expert panel with key stakeholders including Veterans,
primary providers, geriatricians, gastroenterologists, VA leaders, and policy makers to
present Aim 1, 2, and 3a findings (Aim 3b). The primary outcome will be specific
recommendations regarding use of surveillance colonoscopy in older adults, ranked by
priority and feasibility, that can guide VA policy around future implementation (or
de-implementation) of surveillance among older adults.
Arm group label:
Stakeholders
Summary:
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.
Detailed description:
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the United States
(US), with 149,500 new CRC cases, and 52,980 deaths expected in 202119; 4,000 Veterans
are diagnosed with CRC annually. Screening for CRC reduces incidence and mortality, in
part due to detection and removal of polyps such as adenomas. National and VA guidelines
recommend surveillance colonoscopy after adenoma removal (defined herein as polypectomy),
but the incremental benefit of surveillance after polypectomy on reducing CRC incidence
and mortality are uncertain. For adults age 75 and older ("older adults") considering
surveillance colonoscopy, these issues are of particular importance. Harms associated
with colonoscopy increase dramatically with age, with 3.8% to 6.8% of older adults
experiencing an emergency visit or hospitalization within 30 days of colonoscopy. Older
vs. younger adults have a 1.5 to 3.7-fold increase in post-colonoscopy complications.
Older adults also are less likely to live long enough to benefit from interventions such
as surveillance colonoscopy, due to competing, non-CRC mortality risks. The
well-established age-related increasing risks for competing causes of mortality and
colonoscopy-related harms stand in sharp contrast to major evidence gaps: it is unclear
whether CRC risk is clinically significant among older adults with prior history of
polyps, and whether exposing older adults to surveillance reduces CRC risk. Yet, the
default clinical paradigm is for many older adults to receive surveillance colonoscopy.
In the VA, surveillance is a very common indication for colonoscopy among older Veterans,
with an estimated >17,400 exposed to surveillance annually. The mismatch between
available evidence and current clinical practice, coupled with extreme constraints on
colonoscopy resources in the VA, make the surveillance colonoscopy paradigm an ideal
focus area for quantifying risks and benefits to optimize health outcomes. The
Overarching Aim is to advance knowledge on CRC risks among older adults with prior
polypectomy and potential benefits of surveillance colonoscopy, with the goal of
informing policies and clinical strategies that optimize benefits, risks, and resource
utilization. The Specific Aims are to:
Aim 1. Compare cumulative CRC risk after age 75 in a cohort of older adults with history
of normal colonoscopy (n=101,328) vs. colonoscopy with polypectomy (n=29,548) prior to
age 75. After normal colonoscopy, US Preventive Services Task Force guidelines note that
benefits of repeat screening in older adults are likely minimal and recommend selective
screening. Finding no CRC risk difference for older adults with prior normal colonoscopy
vs. polypectomy would suggest surveillance guidelines should follow a similar approach.
Risk analyses will also be stratified by baseline adenoma type (low vs. high risk).
Hypothesis: Cumulative risk for incident CRC (primary analysis) and fatal CRC (secondary
analysis) after age 75 will be similar in older adults with normal colonoscopy vs.
colonoscopy with polypectomy prior to age 75.
Aim 2. Among older adults with polypectomy prior to age 75, assess comparative
effectiveness of exposure vs. no exposure to surveillance colonoscopy after age 75 for
reducing CRC risk using a case-cohort design. Cases with incident (n=270) and fatal CRC
(n=150), and a random sample subcohort with prior polypectomy (n=1,036) will undergo
rigorous chart review to ascertain exposure to surveillance colonoscopy. Harms associated
with surveillance will be characterized. Risk analyses will also be stratified by
baseline adenoma type (low vs. high risk). Hypothesis: Older adults unexposed vs. exposed
to surveillance will have similar risk for incident CRC (primary analysis) and fatal CRC
(secondary analysis).
Aim 3. Obtain multi-level stakeholder perspectives regarding CRC risk and surveillance
outcomes to inform future use and VA policy regarding surveillance colonoscopy in older
Veterans. The investigators will conduct 44 semi-structured one-on-one qualitative
interviews with VA patients (older adults) and providers (primary care, GI, geriatrics)
to understand perspectives on CRC risk, and potential benefits and harms of surveillance
(Aim 3a). The investigators will then convene an expert panel with key stakeholders
including Veterans, primary providers, geriatricians, gastroenterologists, VA leaders,
and policy makers to present Aim 1, 2, and 3a findings (Aim 3b). The primary outcome will
be specific recommendations regarding use of surveillance colonoscopy in older adults,
ranked by priority and feasibility, that can guide VA policy around future implementation
(or de-implementation) of surveillance among older adults.
Impact: Establishing CRC risk among older adults with prior polypectomy, and outcomes
associated with surveillance, will fill critical evidence gaps and inform guidelines
within and outside VA. Multi-stakeholder perspectives on CRC risk and surveillance
outcomes will pave the way for future implementation of evidence-based, Veteran-centric,
and optimized value strategies for surveillance among older adults. This work will also
serve as a model for leveraging VA data to address an important population health
challenge for the VA's large and growing older adult population, and to use these data to
engage Veterans, healthcare providers, and policy makers in identifying interventions
which can be scaled and sustained to optimize outcomes.
Criteria for eligibility:
Study pop:
Older adults at risk for colorectal cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
Study Base and Inclusion Criteria, Aim 1:
- 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
Study Base and Inclusion Criteria for Cases and Subcohort, Aim 2:
- 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
Inclusion Criteria, Aim 3a:
Participant selection for qualitative interviews. Patient Selection:
- 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
Provider Selection:
- 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
Participant selection for expert panel:
- 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
Exclusion Criteria:
Study Base and Exclusion Criteria, Aim 1:
- 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
Study Base and Exclusion Criteria for Cases and Subcohort, Aim 2:
- All candidate CRC cases and members for the subcohort will be included in the
analytic sample unless they meet one of the following exclusion criteria:
- absence of a reviewable colonoscopy note
- absence of polypectomy with adenoma diagnosis at candidate qualifying
colonoscopy event
- presence of a SSL, TSA, or LSP
- history of CRC or IBD
- history of hereditary cancer syndrome (this criteria is not used for Aim 1
because it cannot be reliably assessed with structured EHR data)
Gender:
All
Minimum age:
75 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
VA San Diego Healthcare System, San Diego, CA
Address:
City:
San Diego
Zip:
92161-0002
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samir Gupta, MD MS
Phone:
858-552-8585
Phone ext:
2475
Email:
samir.gupta@va.gov
Investigator:
Last name:
Samir Gupta, MD MS
Email:
Principal Investigator
Facility:
Name:
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Address:
City:
West Los Angeles
Zip:
90073-1003
Country:
United States
Status:
Recruiting
Contact:
Last name:
Folasade P May
Phone:
310-478-3711
Email:
Folasade.May@va.gov
Start date:
October 1, 2023
Completion date:
September 30, 2027
Lead sponsor:
Agency:
VA Office of Research and Development
Agency class:
U.S. Fed
Source:
VA Office of Research and Development
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05994482
