Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

NCT ID: NCT02810652

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2022-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Perioperative Geriatrics Intervention

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

Group Type: EXPERIMENTAL

Perioperative Geriatrics Intervention

Intervention Type: OTHER

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.

Standard Care

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).

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Comprehensive Cancer Network

NETWORK

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ryan Nipp

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Nipp, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts general Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

16-189

Identifier Type: -

Identifier Source: org_study_id