Clinical trial NCT02810652: Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
Official title: Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Esophageal Cancer
Gastric Cancer
Rectal Cancer
Hepatobiliary Cancer
Colon Cancer
Keywords: Cancer Surgery Care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2016-06-23
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Hospital Length Of Stay
timeFrame: 2 years
Secondary outcomes:
measure: 30-day readmission rate
timeFrame: 2 years
measure: Time to readmission
timeFrame: 2 years
measure: Change In patients' QOL From Baseline To Post-Intervention
timeFrame: 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)]
measure: Change In Patients' Symptom Scores From Baseline To Post-Intervention
timeFrame: 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)]
measure: Change In Patients' Depression From Baseline To Post-Intervention
timeFrame: 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)]
measure: Rates Of Post-Intervention Depression Symptoms
timeFrame: 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)]
measure: Rates Of Post-Intervention Moderate/Severe Symptoms
timeFrame: 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)]
measure: Change In Activities of Daily Living (ADLs) / Instrumental Activities of Daily Living (IADLs) From Baseline To Post-Intervention
timeFrame: 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)]
measure: Change In The Number Of Falls During The Past 6 Months (measured continuously) From Baseline To Post-Intervention.
timeFrame: 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)]
measure: Rates Of Post-Intervention Activity of Daily Living (ADL) Deficits
timeFrame: 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)]
measure: Rates Of Post-Intervention Instrumental Activity of Daily Living (IADL) Deficits
timeFrame: 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)]
measure: Rates Of Post-Intervention Falls
timeFrame: 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)]
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan Nipp, MD
role: PRINCIPAL_INVESTIGATOR
References: