Clinical trial NCT02708381: Pilot Testing of a Real-Time Oncogeriatric Teleconsultation System Using the Total Cancer Care™ Database
Official title: Pilot Testing of a Real-Time Oncogeriatric Teleconsultation System Using the Total Cancer Care™ Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncology Problem
Keywords: Population 70 years and older
Geriatric
Oncogeriatric
Senior adult
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Lynn Cancer Institute
First posted: 2016-03-15
Enrollment: 31
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cancer patients 70 years of age and older being treated at Lynn Cancer Institute, with geriatric issues.

Brief summary: The main purpose of this study is to pilot a real time electronic consultation with an Oncogeriatric Information Team (OGIT) located at Moffitt using Total Cancer Care (TCC). Investigators want to see for which type of patients this information is the most useful, and work out the practical ways of making this process work.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Availability of Matching Patients in Moffitt Database
timeFrame: Up to 24 months
Secondary outcomes:
measure: Impact of Oncogeriatric Information Team (OGIT) Consultation on Treatment Plan
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Lynn Cancer Institute, Boca Raton Regional Hospital
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Martine Extermann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dougoud-Chauvin V, Lee JJ, Santos E, Williams VL, Battisti NML, Ghia K, Sehovic M, Croft C, Kim J, Balducci L, Kish JA, Extermann M. Using Big Data in oncology to prospectively impact clinical patient care: A proof of concept study. J Geriatr Oncol. 2018 Nov;9(6):665-672. doi: 10.1016/j.jgo.2018.03.017. Epub 2018 Apr 17.