Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Recruiting

CT.gov ID

NCT03857620

Collaborator

National Cancer Institute (NCI) (NIH)

450

Enrollment

Locations

Arms

Anticipated Duration (Months)

10.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Neoplasm Surgical Procedure, Unspecified Health Care Provider Carcinoma	Other: Best Practice Other: Informational Intervention Other: Questionnaire Administration Other: Informational Intervention with Coaching	N/A

Detailed Description

PRIMARY OBJECTIVES:

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:

To compare postoperative morbidity between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I (usual care) Healthcare providers/institutions perform usual care.	Other: Best Practice Receive usual care Other: Questionnaire Administration Ancillary studies
Experimental: Arm II (OPTI-Surg training and materials) Healthcare providers/institutions receive OPTI-Surg training and informational materials.	Other: Informational Intervention Receive OPTI-Surg program materials Other: Questionnaire Administration Ancillary studies
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

Arm

Intervention/Treatment

Active Comparator: Arm I (usual care)

Healthcare providers/institutions perform usual care.

Other: Best Practice

Receive usual care

Other: Questionnaire Administration

Ancillary studies

Experimental: Arm II (OPTI-Surg training and materials)

Healthcare providers/institutions receive OPTI-Surg training and informational materials.

Other: Informational Intervention

Receive OPTI-Surg program materials

Other: Questionnaire Administration

Ancillary studies

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

Outcome Measures

Primary Outcome Measures

Patient function per Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire [At 8 weeks post surgery]
The primary analysis will employ a generalized linear mixed model (with Gaussian link function) with a random practice effect to account for clustering within practice and baseline CHAMPS total score as a covariate to compare 8-week CHAMPS total score between the combined OPTI-Surg no-coach and coach arms versus usual care. This analysis will include all eligible elderly patients who undergo major cancer surgery, consent to complete CHAMPS questionnaires, and have baseline and 8-week function measured. The CHAMPS questionnaire includes 41 questions and 4 subscales measuring caloric expenditure and frequency/week of all exercise-related activities and only moderate-intensity exercise-related activities. The caloric activities subscales are scored by weighting the duration items using MET values and converting them to a caloric expenditure/week. The frequency/week subscales are scored by summing the frequency scores/week for each activity.

Secondary Outcome Measures

Postoperative complications (Clavien-Dindo grades I-V) [Up to 12 weeks]
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 postoperative complications within 12 weeks of surgery between the combined OPTI-Surg no-coach and coach arms versus usual care followed by pairwise comparisons. This analysis will include all eligible elderly patients who undergo major cancer surgery (no documentation of postoperative complications will be considered as not having any postoperative complications).
Compliance with administration of Edmonton Frail Scale (EFS) [Up to 9 months]
A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will also be used to compare compliance rate (i.e., percentage) for screening between the no-coach and coach arms. The endpoint is whether the EFS was administered, not the EFS scores themselves.

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
2	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
3	Augusta University Medical Center	Augusta	Georgia	United States	30912
4	Memorial Health University Medical Center	Savannah	Georgia	United States	31404
5	Queen's Medical Center	Honolulu	Hawaii	United States	96813
6	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453-2699
7	Carle Cancer Center	Urbana	Illinois	United States	61801
8	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
9	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
10	University of Kansas Cancer Center	Kansas City	Kansas	United States	66160
11	University of Kansas Hospital-Westwood Cancer Center	Westwood	Kansas	United States	66205
12	LSU Healthcare Network / Metairie Multi-Specialty Clinic	Metairie	Louisiana	United States	70006
13	Louisiana State University Health Science Center	New Orleans	Louisiana	United States	70112
14	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
15	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
16	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
17	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
18	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
19	Baptist Memorial Hospital and Cancer Center-Desoto	Southhaven	Mississippi	United States	38671
20	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
21	CoxHealth South Hospital	Springfield	Missouri	United States	65807
22	Morristown Medical Center	Morristown	New Jersey	United States	07960
23	Overlook Hospital	Summit	New Jersey	United States	07902
24	Montefiore Medical Center-Einstein Campus	Bronx	New York	United States	10461
25	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467
26	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
27	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
28	Sanford Roger Maris Cancer Center	Fargo	North Dakota	United States	58122
29	Miami Valley Hospital South	Centerville	Ohio	United States	45459
30	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	United States	18103
31	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
32	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
33	Baptist Memorial Hospital and Cancer Center-Memphis	Memphis	Tennessee	United States	38120
34	VCU Massey Cancer Center at Stony Point	Richmond	Virginia	United States	23235
35	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298
36	Ascension Southeast Wisconsin Hospital - Elmbrook Campus	Brookfield	Wisconsin	United States	53045
37	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin	United States	54701
38	Ascension Southeast Wisconsin Hospital - Franklin	Franklin	Wisconsin	United States	53132
39	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin	United States	54449
40	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
41	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
42	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin	United States	54868
43	Marshfield Medical Center-River Region at Stevens Point	Stevens Point	Wisconsin	United States	54482
44	Marshfield Medical Center - Weston	Weston	Wisconsin	United States	54476

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Investigators

Study Chair: George J. Chang, MD, MS, The University of Texas MD Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT03857620

Other Study ID Numbers:

A231601CD
NCI-2018-01512
UG1CA189823

First Posted:

Feb 28, 2019

Last Update Posted:

Aug 3, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Aug 3, 2022