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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma; Malignant Neoplasm; Surgical Procedure, Unspecified; Health Care Provider
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Informational Intervention; Other: Informational Intervention with Coaching

Detailed Description

PRIMARY OBJECTIVES:

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.

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Helen F Graham Cancer Center
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Queen's Medical Center
  • Illinois
    • Oak Lawn, Illinois, United States, 60453-2699
      • Advocate Christ Medical Center
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Iowa Methodist Medical Center
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center - Des Moines
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Cancer Center
    • Westwood, Kansas, United States, 66205
      • University of Kansas Hospital-Westwood Cancer Center
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • LSU Healthcare Network / Metairie Multi-Specialty Clinic
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Science Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Saint Joseph Mercy Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health at Butterworth Campus
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Medical Health Center
  • Mississippi
    • Southhaven, Mississippi, United States, 38671
      • Baptist Memorial Hospital and Cancer Center-Desoto
  • Missouri
    • Springfield, Missouri, United States, 65807
      • CoxHealth South Hospital
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • Summit, New Jersey, United States, 07902
      • Overlook Hospital
  • New York
    • New York, New York, United States, 10032
      • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center-Einstein Campus
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center - Moses Campus
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Roger Maris Cancer Center
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Miami Valley Hospital South
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital-Cedar Crest
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Greenville Memorial Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital and Cancer Center-Memphis
  • Virginia
    • Richmond, Virginia, United States, 23235
      • VCU Massey Cancer Center at Stony Point
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center
  • Wisconsin
    • Brookfield, Wisconsin, United States, 53045
      • Ascension Southeast Wisconsin Hospital - Elmbrook Campus
    • Eau Claire, Wisconsin, United States, 54701
      • Marshfield Medical Center-EC Cancer Center
    • Franklin, Wisconsin, United States, 53132
      • Ascension Southeast Wisconsin Hospital - Franklin
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Medical Center-Marshfield
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center
    • Minocqua, Wisconsin, United States, 54548
      • Marshfield Clinic-Minocqua Center
    • Rice Lake, Wisconsin, United States, 54868
      • Marshfield Medical Center-Rice Lake
    • Stevens Point, Wisconsin, United States, 54482
      • Marshfield Medical Center-River Region at Stevens Point
    • Weston, Wisconsin, United States, 54476
      • Marshfield Medical Center - Weston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (usual care); Healthcare providers/institutions perform usual care.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care
Experimental: Arm II (OPTI-Surg training and materials); Healthcare providers/institutions receive OPTI-Surg training and informational materials.	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention; Receive OPTI-Surg program materials
Experimental: Arm III (OPTI-Surg training and materials, coach); Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.	Other: Questionnaire Administration; Ancillary studies; Other: Informational Intervention with Coaching; Receive OPTI-Surg program materials plus individual coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Postoperative Complications (Clavien-Dindo Grades I-V)	Postoperative complications were assessed at 12 weeks following surgery using the Clavien-Dindo classification: Grade I: Any deviation from the normal postoperative course w/out the need for pharmacological treatment or surgical, endoscopic, and radiological interventions Grade II: Requiring pharmacological treatment w/ drug other than such allowed for Grade I complications Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grave IV: Life-threatening complication Grade IVa: Single organ dysfunction Grade IVb: Multiorgan dysfunction Grave V: Death A generalized linear mixed model (with logit link function) with random practice effect to account for clustering within practice will be used to compare postoperative complications within 12 weeks of surgery between the combined OPTI-Surg no-coach & coach arms vs usual care followed by pairwise comparisons	12 weeks
Compliance Rate With Administration of Edmonton Frail Scale (EFS)	EFS is a validated measure of frailty that identifies distinct frailty domains that are potential targets for additional pre-operative optimization. For frailty domains that score 1 or 2 points, optimization referrals will be recommended. Clinic or research staff at sites randomized to OPTI-Surg intervention arms will screen and identify eligible patients for administration of the EFS and provide printed surgery preparation materials. A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will be used to compare compliance rate for screening between the no-coach and coach arms.	Day of surgical consult

Collaborators and Investigators

• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: George J. Chang, MD, MS, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Actual): October 31, 2023
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Guidelines as Topic; Quality Assurance, Health Care; Practice Guidelines as Topic
• Other Study ID Numbers: A231601CD; UG1CA189823 (U.S. NIH Grant/Contract); NCI-2018-01512 (Registry Identifier: NCI Clinical Trial Reporting Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No