Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05994482
Status:
RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-08-03
Brief Title:
Surveillance Colonoscopy in Older Adults The SurvOlderAdults Study
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Surveillance Colonoscopy in Older Adults The SurvOlderAdults Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOA
Brief 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 149500 new CRC cases and 52980 deaths expected in 202119 4000 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 38 to 68 of older adults experiencing an emergency visit or hospitalization within 30 days of colonoscopy Older vs younger adults have a 15 to 37-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 17400 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 n101328 vs colonoscopy with polypectomy n29548 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 n270 and fatal CRC n150 and a random sample subcohort with prior polypectomy n1036 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 VAs 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
Aim 1 Compare cumulative CRC risk after age 75 in a cohort of older adults with history of normal colonoscopy n101328 vs colonoscopy with polypectomy n29548 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 n270 and fatal CRC n150 and a random sample subcohort with prior polypectomy n1036 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 VAs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None