Breast NeoplasmsTIPANCT02686918
Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse
A study testing Advanced Practice Nurse consultation in people with Breast Neoplasms, run by Institut de Cancérologie de la Loire.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Advanced Practice Nurse consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Cécile MIGALA, IPA contact
About this study
Official title: 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.
- Conditions
- Breast Neoplasms
- Being tested
- Advanced Practice Nurse consultation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Practice Nurse consultationOther
| Study group | Role | What they receive |
|---|---|---|
| consultation by Advanced Practice Nurse. | Experimental | During consultations, patients will be seen successively by Advanced Practice Nurse and referent oncologist. Receives: Other: Advanced Practice Nurse consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Percentage of consultations delegated to the IPA
The oncologist estimate the percentage of consultations can be delegated to the IPA
Measured: 1 year
Physician satisfaction questionnaire
Physician satisfaction questionnaire of the delegation of his consultations to the IPA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686918
- Sponsor's protocol ID
- 2016-01
- Acronym
- TIPA
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Assessment of a Patients Follow-up Visit Receiving Trastuzumab Subcutaneous by Advanced Practice Nurse - TIPA
- ClinicalTrials.gov ID
- NCT02686918
- Acronym / sponsor ID
- TIPA / 2016-01
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main of this study is to assess the feasibility of a patients follow-up visit receiving trastuzumab subcutaneous by Advanced Practice Nurse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| consultation by Advanced Practice Nurse. | Experimental | Other: Advanced Practice Nurse consultationDuring consultations, patients will be seen successively by Advanced Practice Nurse and referent oncologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Practice Nurse consultation | Other | consultation by Advanced Practice Nurse. |
Primary outcome
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
2 secondary outcomes
Percentage of consultations delegated to the IPA
Time frame: 1 year
Physician satisfaction questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile MIGALA, IPA contact
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Practice Nurse consultation in people with Breast Neoplasms, run by Institut de Cancérologie de la Loire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu ORIOL, MD (04 77 91 70 71, mathieu.oriol@icloire.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of consultation requiring a medical advice between IPA and oncologist (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.