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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perioperative Geriatrics Intervention | Experimental | Evaluation with a board-certified geriatric clinician, both pre- and post-operatively. |
|
| Standard Care | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length Of Stay | Hospital length of stay from admission to discharge | 2 years |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Nipp, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts general Hospital | Boston | Massachusetts | 02114 | United States |
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| Perioperative Geriatrics Intervention | Other | 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. |
|
| 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)] |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
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