- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04917848
A Study of a Telemedicine Program for Older Adults With Cancer
September 25, 2023 updated by: Memorial Sloan Kettering Cancer Center
Tele-Geriatric Oncology Program: Geriatric Assessment Via Telemedicine for Older Adults With Cancer
The purpose of this study is to find out if a telemedicine program for older adults in cancer treatment is a practical way to understand and meet these participants' unique needs.
Telemedicine is the use of secure video technology on a desktop computer, laptop, smartphone, or tablet to provide and receive healthcare from a distance.
The telemedicine program used in this study is called a tele-geriatric oncology program.
It involves the participant and a study nurse meeting by videoconferencing during 2-6 telemedicine visits.
As part of the program, the participant and the study nurse will discuss the participant's symptoms and aging-related needs.
Study Overview
Study Type
Observational
Enrollment (Estimated)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Koshy Alexander, MBBS
- Phone Number: 646-888-3696
- Email: alexandk@mskcc.org
Study Contact Backup
- Name: William Tew, MD
- Phone Number: 646-888-4220
- Email: teww@MSKCC.ORG
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Koshy Alexander, MBBS
- Phone Number: 646-888-3696
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The medical oncology team (medical oncologists, nurse practitioners or registered nurses), who have an established medical relationship with potential participants, will identify potentially eligible participants for the proposed study.
Participants of all genders and ethnicities will be considered for participation.
Participant eligibility will be determined by the clinical research staff.
A consenting professional will comprehensively go through the details of the study with participants and provide participants with time to ask questions and have them answered fully.
Description
Inclusion Criteria:
- Age 70 or older
- Gastrointestinal or gynecological cancer.
- Receiving or about to receive medical cancer treatment (e.g., chemotherapy, immunotherapy, targeted therapy, biological agents)
Exclusion Criteria:
- Inability of the patient or caregiver to read or comprehend English
- No internet connection at home
- No electronic device with videoconferencing capability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Older adults with cancer
Participants will be 70 years old or older with a diagnosis of gastrointestinal or gynecological cancer.
Participants will be receiving or about to receive medical cancer treatment (e.g., chemotherapy, immunotherapy, targeted therapy, biological agents)
|
Participants will be scheduled to meet with a Geriatric Nurse Practitioner (GNP) or Geriatric Registered Nurse (GRN) via the program's telemedicine platform.
The telemedicine encounters with the GNP/GRN may occur every 2 weeks over 3 months, for a total of 6 visits.
Visits 1 and 6 are mandatory, and visits 2-5 are on an as needed basis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of Tele-Geriatric Oncology Program
Time Frame: 18 months
|
We will report the proportion (and CI) of optional telemedicine visits attended by enrolled participants out of the total number of scheduled optional telemedicine encounters.
As participants could have multiple scheduled optional appointments and these appointments for the same participant would be correlated, the confidence interval will be calculated based on bootstrapping our original sample.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Beatriz Korc-Grodzicki, MD, MPH, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
June 2, 2021
First Submitted That Met QC Criteria
June 2, 2021
First Posted (Actual)
June 8, 2021
Study Record Updates
Last Update Posted (Actual)
September 26, 2023
Last Update Submitted That Met QC Criteria
September 25, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21-200
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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