5 Years Follow-up With Adjuvant Therapy for Women With Breast Invasive Carcinoma (HACAMI)

August 7, 2018 updated by: Institut de Cancérologie de Lorraine

5 Years Follow-up in the Lorraine Institute of Oncology With Adjuvant Therapy for Women With Breast Invasive Carcinoma

Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandoeuvre lès Nancy, France, 54500
        • Institut de Cancérologie de Lorraine

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

Female

Sampling Method

Probability Sample

Study Population

Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy

Description

Inclusion Criteria:

  • Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy
  • Women with breast invasive carcinoma positive-RH and indication of adjuvant hormonal therapy
  • Adult patients
  • Being capable and agree to follow the study procedure
  • Patients informed and non-opposed
  • Covered by social security

Exclusion Criteria:

  • History of other cancer except basal cell carcinoma
  • Patients with breast invasive carcinoma negative-RH
  • Synchronous metastases
  • Relapsed
  • Previous adjuvant hormonal therapy
  • Men
  • Patients with guardianship

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients followed for a medical consultation in the Institut de Cancérologie de Lorraine at 5 years of the beginning of an adjuvant hormonal therapy.
Other: questionnary of quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors associated with persistence to hormone therapy for breast cancer
Time Frame: 1 day

Women will be classed as persistent if they don't discontinue or abandon hormone therapy during the 5 years after the introduction of the medication. The information will be recorded thanks to a self-questionnary fulfilled the inclusion day.

The baseline characteristics will be compared between persistent women and non-persistent women.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the quality of life
Time Frame: 1 day
Quality of life between patients who continued hormone therapy for 5 years and patients who discontinued treatment early will be searched for using the questionnaire
1 day
Proportion of women with a change in their treatment
Time Frame: 1 day
Proportion of women who have changed treatment within 5 years following the placing on hormone therapy and reasons for the change.
1 day
Cause of treatment discontinuation
Time Frame: 1 day
In the subgroup of women who stopped hormone therapy within 5 years following the hormone therapy, determination of the treatment discontinuation.
1 day
Continued homonotherapy
Time Frame: 1 day
In the subgroup of women who have been treated with hormone therapy for 5 years, determine the proportion of women not opposed to the continuation of hormone therapy beyond 5 years
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: LESUR ANNE, Md, Institut de Cancérologie de Lorraine

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 (ACTUAL)

June 3, 2016

Primary Completion (ACTUAL)

June 3, 2017

Study Completion (ACTUAL)

June 3, 2017

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (ESTIMATE)

June 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICL OBS 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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