Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer
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.
- Malignant Neoplasm
- Surgical Procedure, Unspecified
- Health Care Provider
- Eligible Ages
- Over 70 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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 - 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.
- Patients undergoing emergent surgery 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 Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- None (Open Label)
Arm I (usual care)
|Healthcare providers/institutions perform usual care.||
Arm II (OPTI-Surg training and materials)
|Healthcare providers/institutions receive OPTI-Surg training and informational materials.||
Arm III (OPTI-Surg training and materials, coach)
|Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach.||
- Alliance for Clinical Trials in Oncology
Study ContactGeorge J. Chang, MD, MS
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.