NCT02616133

Brief Summary

Currently many patients with HER2+ Breast Cancer do not have the opportunity to be evaluated by a medical oncologist for neo-adjuvant treatment due to the current lack of care coordination between the surgeon/surgical oncologist and the medical oncologists. This project will evaluate the feasibility to enhance knowledge that drives adoption of evidence based care, and evaluate the improvement in care coordination between oncologists and surgeons for patients with HER2+ Breast Cancer in the Neo-Adjuvant setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

4 active sites

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

November 9, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

July 2, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

November 9, 2015

Last Update Submit

June 30, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Coordination of Care efforts evaluation score

    Multiple measurements will be aggregated from across study sites to evaluate coordination of care efforts across different disciplines involved in the care of a breast cancer patient.This evaluation will result in the formation of a multidisciplinary approach to care for breast cancer subjects.

    6 months to one year

Interventions

chart abstractionOTHER

abstraction of breast cancer patients with de-identified data

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Identified patient with breast cancer

You may qualify if:

  • diagnosis of breast cancer

You may not qualify if:

  • no diagnosis of breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Marquette General Hospital

Marquette, Michigan, 49855, United States

Location

DLP Maria Parham Medical Center

Henderson, North Carolina, 27536, United States

Location

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

Location

Augusta Health

Fishersville, Virginia, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Linda Sutton, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 26, 2015

Study Start

January 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

July 2, 2017

Record last verified: 2017-02

Locations

US(4)