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.
|
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.
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.