Automated Geriatric Co-Management Program in Older Patients With Solid Mass or Nodule Suspicious for Cancer

Feasibility and Effectiveness of Automated Geriatric Co-Management Program on Improving the Perioperative Care of Older Patients With Solid Mass or Nodule Suspicious for Cancer

The purpose of this study is to find out if it is possible to use the automated geriatric co-management program to manage the participants care before, during and after surgery.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Other: in-person geriatric co-management; Other: automated geriatric co-management

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armin Shahrokni, MD, MPH; Phone Number: 646-888-3651; Email: shahroka@mskcc.org
• Study Contact Backup: Name: Robert Downey, MD; Phone Number: 212-639-8124

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Solid mass or nodule suspicious for cancer
• Aged 65 or older
• Being considered for surgical resection of the solid mass or nodule, with anticipated hospital length of stay of at least two days,
• Completed the eRFA per routine care

Exclusion Criteria:

• Unable to read or comprehend English
• Not having a completed electronic Rapid Fitness Assessment within 2 months of surgery**Note) To avoid excluding patients based this item, patients have to complete another eRFA within two months of surgery.
• Being discharged in one day or earlier from the hospital.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: In-person geriatric co-management group; "In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.	Other: in-person geriatric co-management; The geriatrics service sees these patients for at least 2 postoperative days, if deemed clinically necessary by the geriatrician. During the inpatient hospital course, the geriatrics service will ensure the execution of preoperative recommendations and will discuss with the surgical team, who will act as a primary team, any additional recommendation in order to improve postoperative care. "In-person" geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety.
Experimental: Automated geriatric co-management program group	Other: automated geriatric co-management; Following completion of the eRFA, the summary of impairments as well as the recommendations generated by the study team (hard-copy or email) will be provided in real-time to the surgery team for their attention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Automated Geriatric Co-management Program	percentage of recommendations that were followed by the surgery team	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Armin Shahrokni, MD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Actual): December 21, 2022
• Study Completion (Actual): December 21, 2022

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Perioperative Care; Automated Geriatric Co-Management Program; Solid mass; Nodule; 19-066
• Other Study ID Numbers: 19-066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No