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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
160
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.
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.
Massachusetts general Hospital
Boston, Massachusetts, United States
Hospital Length Of Stay
Hospital length of stay from admission to discharge
Time frame: 2 years
30-day readmission rate
Defined as the first hospital readmission within 30 days of prior hospital discharge, if patients are readmitted
Time frame: 2 years
Time to readmission
Defined as time from discharge to first readmission.
Time frame: 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)\]
Time frame: 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
Time frame: 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
Time frame: 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)]
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Rates Of Post-Intervention Depression Symptoms
Defined as presence of GDS scores \> 5
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)]