Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse (TIPA)

February 16, 2016 updated by: Institut de Cancérologie de la Loire

Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse - TIPA

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: consultation by Advanced Practice Nurse.
During consultations, patients will be seen successively by Advanced Practice Nurse and referent oncologist.
Other: Advanced Practice Nurse consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of consultation requiring a medical advice between IPA and oncologist
Time Frame: 1 year
Estimate the correlation between the IPA and the oncologist about whether or not a medical opinion during the consultation
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of consultations delegated to the IPA
Time Frame: 1 year
The oncologist estimate the percentage of consultations can be delegated to the IPA
1 year
Physician satisfaction questionnaire
Time Frame: 1 year
Physician satisfaction questionnaire of the delegation of his consultations to the IPA
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de la Loire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 8, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 22, 2016

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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