Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

Mass General Brigham

Status: Completed

Conditions: Gastric Cancer; Esophageal Cancer; Colon Cancer; Hepatobiliary Cancer; Rectal Cancer; Pancreatic Cancer

Treatments: Other: Perioperative Geriatrics Intervention; Other: Usual Care

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02810652

16-189

Details and patient eligibility

About

The purpose of this research study is to addresses the challenge of managing the unique perioperative needs of older cancer patients undergoing surgical resection.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Perioperative Geriatrics Intervention

Experimental group

Description:

Evaluation with a board-certified geriatric clinician, both pre- and post-operatively.

Treatment:

Other: Perioperative Geriatrics Intervention

Standard Care

Active Comparator group

Description:

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).

Treatment:

Other: Usual Care