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Clinical Trials/NCT02810652
NCT02810652
Completed
Not Applicable

Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

Massachusetts General Hospital1 site in 1 country160 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Massachusetts General Hospital
Enrollment
160
Locations
1
Primary Endpoint
Hospital Length Of Stay
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
January 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ryan Nipp

MD

Massachusetts General Hospital

Eligibility 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

Outcomes

Primary Outcomes

Hospital Length Of Stay

Time Frame: 2 years

Hospital length of stay from admission to discharge

Secondary Outcomes

  • 30-day readmission rate(2 years)
  • Time to 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)])
  • 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)])
  • 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)])
  • 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)])
  • 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)])
  • 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)])
  • 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)])
  • 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)])
  • 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)])
  • 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)])

Study Sites (1)

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