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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02810652
Other study ID # 16-189
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date January 2022

Study information

Verified date November 2022
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 160
Est. completion date January 2022
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
United States Massachusetts general Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Length Of Stay Hospital length of stay from admission to discharge 2 years
Secondary 30-day readmission rate Defined as the first hospital readmission within 30 days of prior hospital discharge, if patients are readmitted 2 years
Secondary Time to readmission Defined as time from discharge to first readmission. 2 years
Secondary 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)]
Secondary Change In Patients' Symptom Scores From Baseline To Post-Intervention Edmonton Symptom Assessment System (ESAS) symptom scores measured continuously 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)]
Secondary Change In Patients' Depression From Baseline To Post-Intervention As per Geriatric Depression Scale (GDS) measured continuously 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)]
Secondary Rates Of Post-Intervention Depression Symptoms Defined as presence of GDS scores > 5 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)]
Secondary Rates Of Post-Intervention Moderate/Severe Symptoms Defined as presence of Edmonton Symptom Assessment System (ESAS) scores =4 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)]
Secondary 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 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)]
Secondary Change In The Number Of Falls During The Past 6 Months (measured continuously) From Baseline To Post-Intervention. Patient self-report of 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)]
Secondary Rates Of Post-Intervention Activity of Daily Living (ADL) Deficits Defined as presence of any Activity of Daily Living (ADL) deficit 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)]
Secondary Rates Of Post-Intervention Instrumental Activity of Daily Living (IADL) Deficits Defined as presence of any Instrumental Activity of Daily Living (IADL) deficit 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)]
Secondary Rates Of Post-Intervention Falls Defined as presence of any 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)]
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