Colon Cancer, Esophageal Cancer, Gastric Cancer, Hepatobiliary Cancer, Pancreatic Cancer, Rectal Cancer
Conditions
Keywords
Cancer Surgery 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.
Interventions
OTHERUsual 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.
OTHERPerioperative 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.
Sponsors
National Comprehensive Cancer Network
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length Of Stay | 2 years | Hospital length of stay from admission to discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to readmission | 2 years | Defined as time from discharge to first readmission. |
| 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)\] |
| 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)] | Edmonton Symptom Assessment System (ESAS) symptom scores measured continuously |
| 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)] | As per Geriatric Depression Scale (GDS) measured continuously |
| 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)] | Defined as presence of GDS scores \> 5 |
| 30-day readmission rate | 2 years | Defined as the first hospital readmission within 30 days of prior hospital discharge, if patients are readmitted |
| 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)] | As per the Medical Outcomes Study (MOS) and the Older American Resources and Services (OARS) measured continuously |
| 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)] | Patient self-report of falls |
| 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)] | Defined as presence of any Activity of Daily Living (ADL) deficit |
| 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)] | Defined as presence of any Instrumental Activity of Daily Living (IADL) deficit |
| 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)] | Defined as presence of any falls |
| 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)] | Defined as presence of Edmonton Symptom Assessment System (ESAS) scores ≥4 |
Countries
United States
Outcome results
None listed