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

Breast Neoplasms Clinical Trial

— TIPA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02686918
• Other study ID #: 2016-01
• Status: Not yet recruiting
• Phase: N/A
• First received: February 8, 2016
• Last updated: February 16, 2016
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: Institut de Cancérologie de la Loire
• Contact: Mathieu ORIOL, MD
• Phone: 04 77 91 70 71
• Email: mathieu.oriol[@]icloire.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• Advanced Practice Nurse consultation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of consultations delegated to the IPA	The oncologist estimate the percentage of consultations can be delegated to the IPA	1 year	No
Secondary	Physician satisfaction questionnaire	Physician satisfaction questionnaire of the delegation of his consultations to the IPA	1 year	No