Renal Cell CarcinomaNCT02677337
NCCN Renal Cell Registry
A study testing chart abstraction and Educational Program in people with Renal Cell Carcinoma, run by Duke University at 1 site in United States.
Trial summary
This study will consist of three parts: 1) a retrospective chart review of patients treated for mRCC from July 2013 until the start of the educational intervention; 2) an educational program for DCN community oncology providers and DCN community patients with mRCC, lasting 8 - 10 months, and 3) a second retrospective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- chart abstraction and Educational Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oncology providers (physicians, nurse practitioners, physicians' assistants) at DCN affiliated sites will be invited to use the performance support system and participate in the online virtual tumor boards for CME credit.
Who cannot join
- Non DCN affiliated sites providers
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27707
About this study
Official title: Novel Educational Interventions for Community Oncologists & Patients: Optimizing Renal Cell Carcinoma Outcomes Through Engagement
This study will consist of three parts: 1) a retrospective chart review of patients treated for mRCC from July 2013 until the start of the educational intervention; 2) an educational program for DCN community oncology providers and DCN community patients with mRCC, lasting 8 - 10 months, and 3) a second retrospective chart review of patients treated for mRCC starting at the time of the educational intervention until the intervention is completed.
Read the detailed description
The initial retrospective cohort will serve as the pre-education control, and the second cohort will be the experimental group to assess the efficacy of the educational intervention to change care of patients with mRCC.
Chart Reviews. This study will begin with a multi-site chart review conducted at the Duke Cancer Network affiliated sites. The chart review will begin in late fall, 2015. The Duke Cancer Network team will perform chart abstraction for this study, with a goal of reviewing at least 60 charts of patients treated between July 2013 and October 2015.
The second data collection period will collect data on patients with mRCC seen at DCN sites after the date in fall 2015 when the educational intervention is rolled out. The target will again be at least 60 charts of patients treated during the time the educational intervention is actively available.
- Conditions
- Renal Cell Carcinoma
- Being tested
- chart abstraction, Educational Program
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chart abstractionOther
chart abstraction will be conducted pre and post education intervention to assess efficacy of education at point of care
Educational ProgramOther
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Not described |
| Educational Program | Other | chart abstraction will be conducted post education intervention component. Receives: Other: chart abstraction; Other: Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assignment of patient to appropriate firstline treatment based on Heng Risk criterion
Improvement in the percentage of patients receiving appropriately prescribed first line therapy for metastatic renal cell cancer (mRCC)
Measured: eight to ten months
Secondary outcomes (1)
Percentage of increase in duration of treatment with appropriate first line therapy
Measured: eight to ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Criscione-Schreiber, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677337
- Sponsor's protocol ID
- Pro00065849
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: This trial may potentially be published.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Educational Interventions for Community Oncologists & Patients: Optimizing Renal Cell Carcinoma Outcomes Through Engagement
- ClinicalTrials.gov ID
- NCT02677337
- Acronym / sponsor ID
- Pro00065849
- Conditions
- Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Feb 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.
This study will consist of three parts: 1) a retrospective chart review of patients treated for mRCC from July 2013 until the start of the educational intervention; 2) an educational program for DCN community oncology providers and DCN community patients with mRCC, lasting 8 - 10 months, and 3) a second retrospective chart review of patients treated for mRCC starting at the time of the educational intervention until the intervention is completed.
Detailed description
The initial retrospective cohort will serve as the pre-education control, and the second cohort will be the experimental group to assess the efficacy of the educational intervention to change care of patients with mRCC.
Chart Reviews. This study will begin with a multi-site chart review conducted at the Duke Cancer Network affiliated sites. The chart review will begin in late fall, 2015. The Duke Cancer Network team will perform chart abstraction for this study, with a goal of reviewing at least 60 charts of patients treated between July 2013 and October 2015.
The second data collection period will collect data on patients with mRCC seen at DCN sites after the date in fall 2015 when the educational intervention is rolled out. The target will again be at least 60 charts of patients treated during the time the educational intervention is actively available.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | – |
| Educational Program | Other | Other: chart abstraction, Other: Educational Programchart abstraction will be conducted post education intervention component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Oncology providers (physicians, nurse practitioners, physicians' assistants) at DCN affiliated sites will be invited to use the performance support system and participate in the online virtual tumor boards for CME credit.
Key exclusion criteria (1 listed)
- Non DCN affiliated sites providers
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 |
|---|---|---|
| chart abstractionchart abstraction will be conducted pre and post education intervention to assess efficacy of education at point of care | Other | Educational Program |
| Educational Program | Other | Educational Program |
Primary outcome
Assignment of patient to appropriate firstline treatment based on Heng Risk criterion
Time frame: eight to ten months
Improvement in the percentage of patients receiving appropriately prescribed first line therapy for metastatic renal cell cancer (mRCC)
1 secondary outcome
Percentage of increase in duration of treatment with appropriate first line therapy
Time frame: eight to ten 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 17 Feb 2017.
- Individual participant dataSharing planned: Undecided. This trial may potentially be published.
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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.
Lisa Criscione-Schreiber principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chart abstraction and Educational Program in people with Renal Cell Carcinoma, run by Duke University at 1 site 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 1 inclusion and 1 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 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Assignment of patient to appropriate firstline treatment based on Heng Risk criterion (time frame: eight to ten months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2017.