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Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

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ClinicalTrials.gov Identifier: NCT02810652
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Ryan Nipp, 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Esophageal Cancer Gastric Cancer Other: Usual Care Other: Perioperative Geriatrics Intervention Not Applicable

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 pancreatic, esophageal and gastric 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Hospital Length Of Stay [ Time Frame: 2 years ]
    Hospital length of stay from admission to discharge


Secondary Outcome Measures :
  1. 30-day readmission rate [ Time Frame: 2 years ]
    Defined as the first hospital readmission within 30 days of prior hospital discharge, if patients are readmitted

  2. Time to readmission [ Time Frame: 2 years ]
    Defined as time from discharge to first readmission.

  3. Change In patients' QOL From Baseline To Post-Intervention [ 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)] ]
    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)]

  4. Change In Patients' Symptom Scores From Baseline To Post-Intervention [ 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)] ]
    Edmonton Symptom Assessment System (ESAS) symptom scores measured continuously

  5. Change In Patients' Depression From Baseline To Post-Intervention [ 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)] ]
    As per Geriatric Depression Scale (GDS) measured continuously

  6. Rates Of Post-Intervention Depression Symptoms [ 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)] ]
    Defined as presence of GDS scores > 5

  7. Rates Of Post-Intervention Moderate/Severe Symptoms [ 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)] ]
    Defined as presence of Edmonton Symptom Assessment System (ESAS) scores ≥4

  8. Change In Activities of Daily Living (ADLs) / Instrumental Activities of Daily Living (IADLs) From Baseline To Post-Intervention [ 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)] ]
    As per the Medical Outcomes Study (MOS) and the Older American Resources and Services (OARS) measured continuously

  9. Change In The Number Of Falls During The Past 6 Months (measured continuously) From Baseline To Post-Intervention. [ 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)] ]
    Patient self-report of falls

  10. Rates Of Post-Intervention Activity of Daily Living (ADL) Deficits [ 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)] ]
    Defined as presence of any Activity of Daily Living (ADL) deficit

  11. Rates Of Post-Intervention Instrumental Activity of Daily Living (IADL) Deficits [ 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)] ]
    Defined as presence of any Instrumental Activity of Daily Living (IADL) deficit

  12. Rates Of Post-Intervention 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)] ]
    Defined as presence of any falls



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 65 or older
  • Diagnosed with pancreatic, esophageal or gastric cancer (including patients with prior diagnosis of another cancer)
  • Panning 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810652


Locations
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United States, Massachusetts
Massachusetts general Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Comprehensive Cancer Network
Investigators
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Principal Investigator: Ryan Nipp, MD Massachusetts General Hospital
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Responsible Party: Ryan Nipp, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02810652    
Other Study ID Numbers: 16-189
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ryan Nipp, Massachusetts General Hospital:
Cancer Surgery Care