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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

Tracking Information
First Submitted Date  ICMJE March 20, 2019
First Posted Date  ICMJE March 22, 2019
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE March 19, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
feasibility of automated geriatric co-management program [ Time Frame: 2 years ]
percentage of recommendations that were followed by the surgery team
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
feasibility of automated geriatric co-management program [ Time Frame: 2 years ]
percentage of recommendations that were followed by the thoracic surgery team
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Automated Geriatric Co-Management Program in Older Patients With Solid Mass or Nodule Suspicious for Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: In-person geriatric co-management group
    Intervention: Other: in-person geriatric co-management
  • Experimental: Automated geriatric co-management program group
    Intervention: Other: automated geriatric co-management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Armin Shahrokni, MD, MPH 646-888-3651 shahroka@mskcc.org
Contact: Robert Downey, MD 212-639-8124
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885908
Other Study ID Numbers  ICMJE 19-066
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Armin Shahrokni, MD, MPH Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP