NCT03857620

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Malignant Neoplasm
• Surgical Procedure, Unspecified
• Health Care Provider
• Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Informational Intervention	Receive OPTI-Surg program materials
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Informational Intervention with Coaching	Receive OPTI-Surg program materials plus individual coaching

Timeline

• Start date: 2019-07-24
• Primary completion: 2023-10-31
• Completion: 2025-10-01
• First posted: 2019-02-28
• Last updated: 2025-02-21
• Results posted: 2025-02-21

Locations

44 sites across 1 country: United States