NCT02686918

Brief Summary

The main of this study is to assess the feasibility of a patients follow-up visit receiving trastuzumab subcutaneous by Advanced Practice Nurse.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Status
unknown

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

Study Start

First participant enrolled

February 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 8, 2016

Last Update Submit

February 16, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of consultation requiring a medical advice between IPA and oncologist

    Estimate the correlation between the IPA and the oncologist about whether or not a medical opinion during the consultation

    1 year

Secondary Outcomes (2)

  • Percentage of consultations delegated to the IPA

    1 year

  • Physician satisfaction questionnaire

    1 year

Study Arms (1)

consultation by Advanced Practice Nurse.

EXPERIMENTAL

During consultations, patients will be seen successively by Advanced Practice Nurse and referent oncologist.

Other: Advanced Practice Nurse consultation

Interventions

consultation by Advanced Practice Nurse.

Eligibility Criteria

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

You may qualify if:

  • Patient care at the Cancer Institute Lucien Neuwirth
  • Patient aged over 18 years
  • Patient with breast cancer overexpressing HER2 adjuvant
  • Patient having finished their chemotherapy treatment with IV followed the oncologist day hospital
  • Patient under Trastzumab subcutaneously
  • Patient affiliated or entitled to a social security scheme (mandatory requirement for all studies)

You may not qualify if:

  • Refusal to participate, most patient protected under guardianship.
  • Patient in inability to understand the course of the study
  • Patient with documented history of cognitive or psychiatric disorders.
  • Patients pregnant or lactating
  • Patients under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Cécile MIGALA, IPA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 22, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

December 1, 2017

Last Updated

February 22, 2016

Record last verified: 2016-02