Use of a Pre-Surgical Toolkit in Improving Surgical Care and Outcomes in Older Participants With Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carcinoma
- Health Care Provider
- Malignant Neoplasm
- Surgical Procedure, Unspecified
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 70 years and 125 years
- Gender
- Both males and females
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 im...
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.
Tracking Information
- NCT #
- NCT03857620
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Study Chair: George J. Chang, MD, MS The University of Texas MD Anderson Cancer Center
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