Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer
Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)
3 other identifiers
interventional
325
1 country
44
Brief Summary
This trial studies how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2019
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedStudy Start
First participant enrolled
July 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedResults Posted
Study results publicly available
February 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedApril 30, 2026
April 1, 2026
4.3 years
February 26, 2019
November 6, 2024
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Physical Function 8 Weeks Post-surgery as Measured by the Caloric Expenditure Scale Per Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
The CHAMPS questionnaire includes 41 questions that measures frequency and duration of activities. The primary endpoint is the estimated Caloric Expenditure Per Week measure from the CHAMPS, which is calculated by weighting the duration variable of the 28 exercise-related activities using the corresponding metabolic equivalents (METs) value, then multiplying by 60 to convert METs/minute to METs/hour, then multiplying by participant weight in kg/200 to calculate the caloric expenditure/week score, and then summing the individual item caloric expenditure scores across all 28 items. This scale score was transformed into the unit of kcal. The minimum possible value of the scale is 0 and there is not a defined maximum possible value. Higher scores equate to more kilocalories burned per week, which is a better outcome in the context of this trial.
8 weeks post surgery
Secondary Outcomes (2)
Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V)
12 weeks
Compliance Rate With Administration of Edmonton Frail Scale (EFS)
Day of surgical consult
Study Arms (3)
Arm I (usual care)
ACTIVE COMPARATORHealthcare providers/institutions perform usual care.
Arm II (OPTI-Surg training and materials)
EXPERIMENTALHealthcare providers/institutions receive OPTI-Surg training and informational materials.
Arm III (OPTI-Surg training and materials, coach)
EXPERIMENTALHealthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.
Interventions
Receive OPTI-Surg program materials
Ancillary studies
Receive OPTI-Surg program materials plus individual coaching
Eligibility Criteria
You may qualify if:
- Patients must have known or suspected cancer diagnosis and have one of the following cancer-directed operations planned:
- 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.
You may not qualify if:
- Patients undergoing emergent surgery are not eligible.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin, 53132, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Related Publications (1)
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.
PMID: 37923529DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- George J. Chang, MD, MS
- Organization
- University of Texas MD Anderson Cancer Center
Study Officials
- STUDY CHAIR
George J. Chang, MD, MS
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2019
First Posted
February 28, 2019
Study Start
July 24, 2019
Primary Completion
October 31, 2023
Study Completion (Estimated)
August 1, 2026
Last Updated
April 30, 2026
Results First Posted
February 21, 2025
Record last verified: 2026-04