NCT02677337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

February 3, 2016

Last Update Submit

February 15, 2017

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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)

    eight to ten months

Secondary Outcomes (1)

  • Percentage of increase in duration of treatment with appropriate first line therapy

    eight to ten months

Study Arms (2)

No intervention

NO INTERVENTION

Educational Program

OTHER

chart abstraction will be conducted post education intervention component.

Other: chart abstractionOther: Educational Program

Interventions

chart abstractionOTHER

chart abstraction will be conducted pre and post education intervention to assess efficacy of education at point of care

Educational Program
Educational ProgramOTHER
Educational Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Non DCN affiliated sites providers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27707, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Lisa Criscione-Schreiber

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 9, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations

US(1)