Oncology ProblemNCT02708381
Pilot Testing of a Real-Time Oncogeriatric Teleconsultation System Using the Total Cancer Care™ Database
An observational study of Oncology Problem, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Oncology Problem
- What is being tested?
- Screening
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Mar 2015to 9 Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Adult cancer patients 70 years of age and older being treated at Lynn Cancer Institute, with geriatric issues.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lynn Cancer Institute, Boca Raton Regional Hospital
Boca Raton, Florida, 33486
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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.
Read the 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.
- Conditions
- Oncology Problem
- Being tested
- Screening
- Keywords
- Population 70 years and older, Geriatric, Oncogeriatric, Senior adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Screening for geriatric issues to be referred to the Moffitt Cancer Center Oncogeriatric Information Team (OGIT).
| Study group | Role | What they receive |
|---|---|---|
| Senior Adult Cancer Patients | Cancer patient population 70 years and older, eligible for screening. Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Availability of Matching Patients in Moffitt Database
Percentage of matching patients in Moffitt's Total Cancer Care (TCC) database. Percentage is expected to be greater than 80%.
Measured: Up to 24 months
Secondary outcomes (1)
Impact of Oncogeriatric Information Team (OGIT) Consultation on Treatment Plan
Percentage of patients whose treatment plan was influenced/modified due to OGIT Consultation. Percentage is expected to be equal or greater than 20%.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start19 Mar 2015
- Primary completion9 Feb 2016
- Study completion9 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oncology ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Lynn Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Martine Extermann, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708381
- Sponsor's protocol ID
- MCC-18059
- Status last verified
- Nov 2022
- First submitted
- 12 Feb 2016
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29678669
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of a Real-Time Oncogeriatric Teleconsultation System Using the Total Cancer Care™ Database
- ClinicalTrials.gov ID
- NCT02708381
- Acronym / sponsor ID
- MCC-18059
- Conditions
- Oncology Problem
- Keywords
- Population 70 years and older, Geriatric, Oncogeriatric, Senior adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Lynn Cancer Institute
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- 9 Feb 2016 (actual)
- Study completion
- 9 Feb 2016 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Senior Adult Cancer Patients | – | Other: ScreeningCancer patient population 70 years and older, eligible for screening. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adult cancer patients 70 years of age and older being treated at Lynn Cancer Institute, with geriatric issues.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreeningScreening for geriatric issues to be referred to the Moffitt Cancer Center Oncogeriatric Information Team (OGIT). | Other | Senior Adult Cancer Patients |
Primary outcome
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%.
1 secondary outcome
Impact of Oncogeriatric Information Team (OGIT) Consultation on Treatment Plan
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 29678669Dougoud-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Extermann, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology Problem, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Availability of Matching Patients in Moffitt Database (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02708381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.