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Use of a Pre-surgical Toolkit in Improving Surgical Care and Outcomes in Older Patients with Cancer


Active: No
Cancer Type: Solid Tumor NCT ID: NCT03857620
Trial Phases: Protocol IDs: A231601CD (primary)
A231601CD
A231601CD
NCI-2018-01512
Eligibility: 70 Years and older, Male and Female Study Type: Health services research
Study Sponsor: Alliance for Clinical Trials in Oncology
NCI Full Details: http://clinicaltrials.gov/show/NCT03857620

Summary

This trial studies how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older patients 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 patients' recovery rate and functioning after surgery.

Objectives

PRIMARY OBJECTIVE:
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.

EXPLORATORY OBJECTIVES:
I. To compare postoperative mortality, hospital length of stay, discharge to a facility, and hospital readmission between sites randomized to implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care.
II. To assess subsequent initiation and follow through of appropriate referral for the indicated optimization intervention and assess practice-level structural factors associated with uptake of the OPTI-Surg package.
III. To document and assess barriers and facilitators to implementation and dissemination through mixed-methods research.

OUTLINE: Healthcare providers/institutions are randomized to 1 of 3 arms. Patients 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, patients 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.

Treatment Sites in Georgia

Augusta University Medical Center
1120 15th Street
Augusta, GA 30912
706-721-4430
www.augustahealth.org



Curtis and Elizabeth Anderson Cancer Institute at Memorial University Medical Center
4700 Waters Avenue
Savannah, GA 31404
912-350-8913
www.memorialhealth.com/anderson-cancer-institute.aspx

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.