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

Not Applicable

• Conditions: Breast Neoplasms
• Interventions: Other: Advanced Practice Nurse consultation

• Registration Number: NCT02686918
• Lead Sponsor: Institut de Cancérologie de la Loire

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22
• Primary Completion: 2017-02
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of consultation requiring a medical advice between IPA and oncologist	1 year	Estimate the correlation between the IPA and the oncologist about whether or not a medical opinion during the consultation

Secondary Outcome Measures

Name	Time	Method
Physician satisfaction questionnaire	1 year	Physician satisfaction questionnaire of the delegation of his consultations to the IPA
Percentage of consultations delegated to the IPA	1 year	The oncologist estimate the percentage of consultations can be delegated to the IPA