- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02708381
Pilot Testing of a Real-Time Oncogeriatric Teleconsultation System Using the Total Cancer Care™ Database
Study Overview
Detailed Description
This is a multicenter study to test a real time consultation system using the Total Cancer CareTM database (TCC) cohort at the H. Lee Moffitt Cancer Center, Tampa, Florida, USA. The purpose is to make Moffitt's expertise available to private practice oncologists throughout Florida. An oncologist seeing an older patient with a difficult case could send key patient parameters to a senior adult expert at Moffitt. The TCC concierge would extract from the TCC database patients with similar characteristics. The oncogeriatric information team (OGIT) would review those cases and provide a summary report of treatments received and outcomes. The treating oncologist could then use that as an on-demand case series to help in the decision making. In order to pilot and build up the large scale intervention, several steps are necessary. The first step was a scenario testing with vignettes, which allowed tracing the most effective way of retrieving and formatting the information. The next step will be a pilot testing of the intervention in real time with one private practice.
Primary Aims:
To assess which format of expert-vetted database consultation and patient selection is the most useful to a private practice oncologist. We will test a model of approach and gain feedback on subjective utility and objective treatment modification profiles, in order to target a future study towards the stakeholders most likely to benefit. Impact of the consultation on treatment plan (per pre-post e-mails). Availability of similar patients in the TCC database.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
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Boca Raton, Florida, United States, 33486
- Lynn Cancer Institute, Boca Raton Regional Hospital
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 70 or older with a documented malignancy seen at Lynn Cancer Institute (LCI), as a new or established patient, and for whom a treatment decision has to be made.
- Signed written informed consent
Exclusion Criteria:
- Patients younger than 70 years of age
- Inability to consent
- Inability to complete the study questionnaires (assistance for physical impairments is allowed)
- Urgent treatment decision need
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Senior Adult Cancer Patients
Cancer patient population 70 years and older, eligible for screening.
|
Screening for geriatric issues to be referred to the Moffitt Cancer Center Oncogeriatric Information Team (OGIT).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Availability of Matching Patients in Moffitt Database
Time Frame: Up to 24 months
|
Percentage of matching patients in Moffitt's Total Cancer Care (TCC) database.
Percentage is expected to be greater than 80%.
|
Up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of Oncogeriatric Information Team (OGIT) Consultation on Treatment Plan
Time Frame: Up to 24 months
|
Percentage of patients whose treatment plan was influenced/modified due to OGIT Consultation.
Percentage is expected to be equal or greater than 20%.
|
Up to 24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martine Extermann, M.D., Ph.D., H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-18059
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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