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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Best Practice
* Other: Informational Intervention
* Other: Questionnaire Administration
* Other: Informational Intervention with Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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. Exclusion Criteria: Patients undergoing emergent surgery are not eligible. Patients under active treatment such as chemotherapy, targeted therapy, immunotherapy, radiation treatment, etc. for second primary, 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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (usual care)<br>Healthcare providers/institutions perform usual care. | Other: Best Practice<br>* Receive usual care<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (OPTI-Surg training and materials)<br>Healthcare providers/institutions receive OPTI-Surg training and informational materials. | Other: Informational Intervention<br>* Receive OPTI-Surg program materials<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm III (OPTI-Surg training and materials, coach)<br>Healthcare providers/institutions receive OPTI-Surg training and informational materials and meet with a coach. | Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Informational Intervention with Coaching<br>* Receive OPTI-Surg program materials plus individual coaching<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient function per Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire | The primary analysis will employ a generalized linear mixed model (with Gaussian link function) with a random practice effect to account for clustering within practice and baseline CHAMPS total score as a covariate to compare 8-week CHAMPS total score between the combined OPTI-Surg no-coach and coach arms versus usual care. This analysis will include all eligible elderly patients who undergo major cancer surgery, consent to complete CHAMPS questionnaires, and have baseline and 8-week function measured. The CHAMPS questionnaire includes 41 questions and 4 subscales measuring caloric expenditure and frequency/week of all exercise-related activities and only moderate-intensity exercise-related activities. The caloric activities subscales are scored by weighting the duration items using MET values and converting them to a caloric expenditure/week. The frequency/week subscales are scored by summing the frequency scores/week for each activity. | At 8 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications (Clavien-Dindo grades I-V) | A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will be used to compare postoperative complications within 12 weeks of surgery between the combined OPTI-Surg no-coach and coach arms versus usual care followed by pairwise comparisons. This analysis will include all eligible elderly patients who undergo major cancer surgery (no documentation of postoperative complications will be considered as not having any postoperative complications). | Up to 12 weeks | 
| Compliance with administration of Edmonton Frail Scale (EFS) | A generalized linear mixed model (with logit link function) with a random practice effect to account for clustering within practice will also be used to compare compliance rate (i.e., percentage) for screening between the no-coach and coach arms. The endpoint is whether the EFS was administered, not the EFS scores themselves. | Up to 9 months |