NCT03885908

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 25, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

March 20, 2019

Results QC Date

September 22, 2023

Last Update Submit

September 22, 2023

Conditions

Cancer

Keywords

Automated Geriatric Co-Management ProgramPerioperative CareSolid massNodule19-066

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Automated Geriatric Co-management Program

    percentage of recommendations that were followed by the surgery team

    2 years

Study Arms (2)

In-person geriatric co-management group

ACTIVE COMPARATOR

"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

Automated geriatric co-management program group

EXPERIMENTAL
Other: automated geriatric co-management

Interventions

in-person geriatric co-managementOTHER

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.

In-person geriatric co-management group
automated geriatric co-managementOTHER

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.

Automated geriatric co-management program group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

Title
Dr. Armin Shahrokni, MD, MPH
Organization
Memorial Sloan Kettering Cancer Center
shahroka@mskcc.org
646-888-3651

Study Officials

  • Armin Shahrokni, MD, MPH

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The proposed study is a randomized controlled trial study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 22, 2019

Study Start

March 19, 2019

Primary Completion

December 21, 2022

Study Completion

December 21, 2022

Last Updated

March 25, 2024

Results First Posted

March 25, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP, ICF

Locations

US(1)