Back to resultsFeasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse (TIPA)
Primary Purpose
Breast Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Advanced Practice Nurse consultation
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Neoplasms
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
consultation by Advanced Practice Nurse.
Arm Description
During consultations, patients will be seen successively by Advanced Practice Nurse and referent oncologist.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Percentage of consultations delegated to the IPA
The oncologist estimate the percentage of consultations can be delegated to the IPA
Physician satisfaction questionnaire
Physician satisfaction questionnaire of the delegation of his consultations to the IPA
Full Information
NCT ID
NCT02686918
First Posted
February 8, 2016
Last Updated
February 16, 2016
Sponsor
Institut de Cancérologie de la Loire
1. Study Identification
Unique Protocol Identification Number
NCT02686918
Brief Title
Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse
Acronym
TIPA
Official Title
Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse - TIPA
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de la Loire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
consultation by Advanced Practice Nurse.
Arm Type
Experimental
Arm Description
During consultations, patients will be seen successively by Advanced Practice Nurse and referent oncologist.
Intervention Type
Other
Intervention Name(s)
Advanced Practice Nurse consultation
Primary Outcome Measure Information:
Title
Percentage of consultation requiring a medical advice between IPA and oncologist
Description
Estimate the correlation between the IPA and the oncologist about whether or not a medical opinion during the consultation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of consultations delegated to the IPA
Description
The oncologist estimate the percentage of consultations can be delegated to the IPA
Time Frame
1 year
Title
Physician satisfaction questionnaire
Description
Physician satisfaction questionnaire of the delegation of his consultations to the IPA
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu ORIOL, MD
Phone
04 77 91 70 71
Email
mathieu.oriol@icloire.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile MIGALA, IPA
Email
cecile.migala@icloire.fr
12. IPD Sharing Statement
Learn more about this trial
Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse
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