Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
- Conditions
- Rectal CancerHepatobiliary CancerPancreatic CancerGastric CancerColon CancerEsophageal Cancer
- Interventions
- Other: Usual CareOther: Perioperative Geriatrics Intervention
- Registration Number
- NCT02810652
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care Usual 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). Perioperative Geriatrics Intervention Perioperative Geriatrics Intervention Evaluation with a board-certified geriatric clinician, both pre- and post-operatively.
- Primary Outcome Measures
Name Time Method Hospital Length Of Stay 2 years Hospital length of stay from admission to discharge
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Massachusetts general Hospital
🇺🇸Boston, Massachusetts, United States