Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer
NCT ID: NCT03857620
Last Updated: 2025-02-21
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
325 participants
INTERVENTIONAL
2019-07-24
2025-10-31
Brief Summary
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Detailed Description
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I. To compare 8-week postoperative function among elderly patients between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.
SECONDARY OBJECTIVES:
I. To compare postoperative morbidity between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.
II. To compare the penetration of the OPTI-Surg toolkit between sites randomized to implement the OPTI-Surg toolkit with a coach versus sites randomized to implement the OPTI-Surg toolkit without a coach.
Trial Design:
OUTLINE: Healthcare providers/institutions are randomized to 1 of 3 arms. Patients/participants receive the intervention based on which arm their healthcare provider is in.
ARM I: Healthcare providers/institutions perform usual care.
ARM II: Healthcare providers/institutions receive OPTI-Surg training and informational materials.
ARM III: Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
After conclusion of study, participants are followed up at 8 and 12 weeks post surgery, and healthcare providers/institutions are followed up 6-9 months after the last patient is registered.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm I (usual care)
Healthcare providers/institutions perform usual care.
Best Practice
Receive usual care
Questionnaire Administration
Ancillary studies
Arm II (OPTI-Surg training and materials)
Healthcare providers/institutions receive OPTI-Surg training and informational materials.
Informational Intervention
Receive OPTI-Surg program materials
Questionnaire Administration
Ancillary studies
Arm III (OPTI-Surg training and materials, coach)
Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
Questionnaire Administration
Ancillary studies
Informational Intervention with Coaching
Receive OPTI-Surg program materials plus individual coaching
Interventions
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Best Practice
Receive usual care
Informational Intervention
Receive OPTI-Surg program materials
Questionnaire Administration
Ancillary studies
Informational Intervention with Coaching
Receive OPTI-Surg program materials plus individual coaching
Eligibility Criteria
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Inclusion Criteria
* Gastrectomy
* Colectomy
* Proctectomy
* Esophagectomy
* Pancreatectomy
* Hepatectomy
* Total cystectomy
* Partial or total nephrectomy
* Lung lobectomy/pneumonectomy
* Patients with known metastatic disease with a plan for curative intent resection are eligible (e.g. curative liver resection for metastatic colorectal cancer).
* Patients with double primaries undergoing planned curative operation for both are eligible (e.g. synchronous colon cancers undergoing colectomy to treat both).
* Patients must be able to speak and complete questionnaires in English.
Exclusion Criteria
* Patients under active treatment such as chemotherapy, targeted therapy, immunotherapy, radiation treatment, etc. for second primary, are not eligible.
* Patients with second primary are not eligible.
* Patients with known metastatic disease who are undergoing palliative resection are not eligible.
* Patients with psychiatric illness or other mental impairment that would preclude their ability to give informed consent or to participate in the prehabilitation program are not eligible.
70 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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George J. Chang, MD, MS
Role: STUDY_CHAIR
The University of Texas MD Anderson Cancer Center
Locations
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Helen F Graham Cancer Center
Newark, Delaware, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States
Countries
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References
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Zahrieh D, Croghan IT, Inselman JW, Mandrekar SJ. Guidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies. Mayo Clin Proc. 2023 Nov;98(11):1712-1726. doi: 10.1016/j.mayocp.2023.02.019.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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NCI-2018-01512
Identifier Type: REGISTRY
Identifier Source: secondary_id
A231601CD
Identifier Type: -
Identifier Source: org_study_id
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