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

Status
Closed
Cancer Type
Solid Tumor
Trial Phase
Eligibility
70 Years and older, Male and Female
Study Type
Health services research
NCT ID
NCT03857620
Protocol IDs
A231601CD (primary)
A231601CD
A231601CD
NCI-2018-01512
Study Sponsor
Alliance for Clinical Trials in Oncology

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.

Eligibility

  1. 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 resection (wedge resection, segmentectomy, lobectomy, or pneumonectomy)
  2. Age >= 70 years
  3. Patients with known metastatic disease with a plan for curative intent resection are eligible (e.g. curative liver resection for metastatic colorectal cancer).
  4. Patients with double primaries undergoing planned curative operation for both are eligible (e.g. synchronous colon cancers undergoing colectomy to treat both).
  5. Patients must be able to speak and complete questionnaires in English.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.