Status:
ACTIVE_NOT_RECRUITING
Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Neoplasm
Surgical Procedure, Unspecified
Eligibility:
All Genders
70+ years
Phase:
NA
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...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT03857620
Start Date
July 24 2019
End Date
October 1 2025
Last Update
February 21 2025
Active Locations (44)
Enter a location and click search to find clinical trials sorted by distance.
1
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
2
MedStar Washington Hospital Center
Washington D.C., 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