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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885908
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Other: in-person geriatric co-management Other: automated geriatric co-management Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The proposed study is a randomized controlled trial study.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: In-person geriatric co-management group 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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. feasibility of automated geriatric co-management program [ Time Frame: 2 years ]
    percentage of recommendations that were followed by the surgery team


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885908


Contacts
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Contact: Armin Shahrokni, MD, MPH 646-888-3651 shahroka@mskcc.org
Contact: Robert Downey, MD 212-639-8124

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Armin Shahrokni, MD, MPH    646-888-3651      
Contact: Robert Downey, MD    212-639-8124      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Armin Shahrokni, MD, MPH Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03885908    
Other Study ID Numbers: 19-066
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Automated Geriatric Co-Management Program
Perioperative Care
Solid mass
Nodule
19-066