Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

Study Overview
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Brief Summary
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The purpose of this research study is to addresses the challenge of managing the unique perioperative needs of older cancer patients undergoing surgical resection.

Detailed Description
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In the proposed study, the investigators will conduct a randomized controlled trial of a perioperative geriatrics intervention versus usual care in older patients with gastrointestinal (GI) cancers undergoing surgical resection. The perioperative geriatrics intervention will entail pre- and post-operative geriatric care for patients age ≥65 undergoing surgery for gastrointestinal cancers. Specifically, geriatric clinicians will evaluate and manage patients preoperatively in the outpatient setting and postoperatively in the inpatient setting as a consultant. The investigators will evaluate the effect of the perioperative geriatrics intervention on postoperative length of stay (primary outcome) and readmissions in a sample of 160 patients. The investigators will also assess the impact of the perioperative geriatrics intervention on patient-reported outcomes, including quality of life (QOL) and symptom burden. The study will take place at Massachusetts General Hospital.

Official Title
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Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

Conditions
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Colon Cancer, Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Rectal Cancer, Hepatobiliary Cancer

Intervention / Treatment
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* Other: Usual Care
* Other: Perioperative Geriatrics Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 or older Diagnosed with pancreatic, esophageal, rectal, colon, hepatobiliary, or gastric cancer (including patients with prior diagnosis of another cancer) Planning to receive surgical resection at MGH (including both curative and palliative resections) Verbal fluency in English Exclusion Criteria: Unwilling or unable to participate in the study Significant uncontrolled psychiatric disorder (e.g. psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g. dementia, cognitive impairment) which the treating clinician believes prohibits informed consent or participation in the study

Ages Eligible for Study
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Minimum Age: 65 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perioperative Geriatrics Intervention<br>Evaluation with a board-certified geriatric clinician, both pre- and post-operatively. | Other: Perioperative Geriatrics Intervention<br>* Patients randomized to the perioperative geriatrics intervention will undergo evaluation with a board-certified Massachusetts General Hospital (MGH) geriatric clinician, both pre- and post-operatively. The geriatric clinician visits will focus on the following issues: comorbidity, polypharmacy, nutrition, physical and mental function, and social support.<br>|
| Active Comparator: Standard Care<br>Usual care participants will not meet with a geriatric clinician perioperatively, but may receive a geriatric consult upon request or at the discretion of their treating clinician(s). | Other: Usual Care<br>* Usual Care participants will not meet with a geriatric clinician perioperatively, though they may receive a geriatric consult at their request or at the discretion of their treating cancer team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length Of Stay | Hospital length of stay from admission to discharge | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day readmission rate | Defined as the first hospital readmission within 30 days of prior hospital discharge, if patients are readmitted | 2 years | 
| Time to readmission | Defined as time from discharge to first readmission. | 2 years | 
| Change In patients' QOL From Baseline To Post-Intervention | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 
| Change In Patients' Symptom Scores From Baseline To Post-Intervention | Edmonton Symptom Assessment System (ESAS) symptom scores measured continuously | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 
| Change In Patients' Depression From Baseline To Post-Intervention | As per Geriatric Depression Scale (GDS) measured continuously | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 
| Rates Of Post-Intervention Depression Symptoms | Defined as presence of GDS scores > 5 | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 
| Rates Of Post-Intervention Moderate/Severe Symptoms | Defined as presence of Edmonton Symptom Assessment System (ESAS) scores ≥4 | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 
| Change In Activities of Daily Living (ADLs) / Instrumental Activities of Daily Living (IADLs) From Baseline To Post-Intervention | As per the Medical Outcomes Study (MOS) and the Older American Resources and Services (OARS) measured continuously | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 
| Change In The Number Of Falls During The Past 6 Months (measured continuously) From Baseline To Post-Intervention. | Patient self-report of falls | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 
| Rates Of Post-Intervention Activity of Daily Living (ADL) Deficits | Defined as presence of any Activity of Daily Living (ADL) deficit | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 
| Rates Of Post-Intervention Instrumental Activity of Daily Living (IADL) Deficits | Defined as presence of any Instrumental Activity of Daily Living (IADL) deficit | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 
| Rates Of Post-Intervention Falls | Defined as presence of any falls | For all patient-reported outcomes, change from baseline to post-intervention is defined as change from baseline to post-operative day 5 (±1 day) and from baseline to post-operative day 30 (±7 days)] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Surgery Care