Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
Study Details
Study Description
Brief Summary
The purpose of this research study is to addresses the challenge of managing the unique perioperative needs of older cancer patients undergoing surgical resection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Perioperative Geriatrics Intervention Evaluation with a board-certified geriatric clinician, both pre- and post-operatively. |
Other: Perioperative Geriatrics Intervention
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.
|
| Active Comparator: Standard Care 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
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.
|
Outcome Measures
Primary Outcome Measures
- Hospital Length Of Stay [2 years]
Hospital length of stay from admission to discharge
Secondary Outcome Measures
- 30-day readmission rate [2 years]
Defined as the first hospital readmission within 30 days of prior hospital discharge, if patients are readmitted
- Time to readmission [2 years]
Defined as time from discharge to first readmission.
- 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 [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)]]
Edmonton Symptom Assessment System (ESAS) symptom scores measured continuously
- Change In Patients' Depression 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)]]
As per Geriatric Depression Scale (GDS) measured continuously
- Rates Of Post-Intervention Depression Symptoms [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)]]
Defined as presence of GDS scores > 5
- Rates Of Post-Intervention Moderate/Severe Symptoms [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)]]
Defined as presence of Edmonton Symptom Assessment System (ESAS) scores ≥4
- Change In Activities of Daily Living (ADLs) / Instrumental Activities of Daily Living (IADLs) 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)]]
As per the Medical Outcomes Study (MOS) and the Older American Resources and Services (OARS) measured continuously
- Change In The Number Of Falls During The Past 6 Months (measured continuously) 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)]]
Patient self-report of falls
- Rates Of Post-Intervention Activity of Daily Living (ADL) Deficits [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)]]
Defined as presence of any Activity of Daily Living (ADL) deficit
- Rates Of Post-Intervention Instrumental Activity of Daily Living (IADL) Deficits [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)]]
Defined as presence of any Instrumental Activity of Daily Living (IADL) deficit
- Rates Of Post-Intervention 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)]]
Defined as presence of any falls
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts general Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Comprehensive Cancer Network
Investigators
- Principal Investigator: Ryan Nipp, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-189