Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

Pancreatic Cancer Clinical Trial

Official title:

Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810652
• Other study ID #: 16-189
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colon Cancer
• Esophageal Cancer
• Gastric Cancer
• Hepatobiliary Cancer
• Pancreatic Cancer
• Rectal Cancer

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)]