Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection

NCT02810652 | Completed DMC

• 1 other identifier: 16-189
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cancer Surgery Care

Outcome Measures

Primary Outcomes (1)

• Hospital Length Of Stay

  Hospital length of stay from admission to discharge

  2 years

Secondary Outcomes (12)

• 30-day readmission rate

  2 years

• Time to readmission

  2 years

• 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)]

• 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)]

• 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)]

Study Arms (2)

Perioperative Geriatrics Intervention

EXPERIMENTAL

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

Other: Perioperative Geriatrics Intervention

Standard Care

ACTIVE COMPARATOR

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).

Other: Usual Care

Interventions

Usual Care 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.

Standard Care

Perioperative Geriatrics Intervention 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.

Perioperative Geriatrics Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Comprehensive Cancer Network: collaborator

Study Sites (1)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Rectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Intestinal Diseases; Rectal Diseases; Colonic Diseases

Study Officials

• Ryan Nipp, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 23, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: January 1, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)