Back to resultsNCCN Renal Cell Registry
Primary Purpose
Renal Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
chart abstraction
Educational Program
Sponsored by
About this trial
This is an interventional other trial for Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Non DCN affiliated sites providers
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
No intervention
Educational Program
Arm Description
chart abstraction will be conducted post education intervention component.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Percentage of increase in duration of treatment with appropriate first line therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02677337
Brief Title
NCCN Renal Cell Registry
Official Title
Novel Educational Interventions for Community Oncologists & Patients: Optimizing Renal Cell Carcinoma Outcomes Through Engagement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Title
Educational Program
Arm Type
Other
Arm Description
chart abstraction will be conducted post education intervention component.
Intervention Type
Other
Intervention Name(s)
chart abstraction
Intervention Description
chart abstraction will be conducted pre and post education intervention to assess efficacy of education at point of care
Intervention Type
Other
Intervention Name(s)
Educational Program
Primary Outcome Measure Information:
Title
Assignment of patient to appropriate firstline treatment based on Heng Risk criterion
Description
Improvement in the percentage of patients receiving appropriately prescribed first line therapy for metastatic renal cell cancer (mRCC)
Time Frame
eight to ten months
Secondary Outcome Measure Information:
Title
Percentage of increase in duration of treatment with appropriate first line therapy
Time Frame
eight to ten months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Non DCN affiliated sites providers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Criscione-Schreiber
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
This trial may potentially be published.
Learn more about this trial
NCCN Renal Cell Registry
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