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

Completed

• Conditions: Breast Cancer
• Interventions: Other: questionnary of quality of life

• Registration Number: NCT02791750
• Lead Sponsor: Institut de Cancérologie de Lorraine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-25
• Study Start: 2016-06-03
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-07
• Primary Completion: 2017-06-03
• Study Completion: 2017-06-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Factors associated with persistence to hormone therapy for breast cancer	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of women with a change in their treatment	1 day	Proportion of women who have changed treatment within 5 years following the placing on hormone therapy and reasons for the change.
Comparison of the quality of life	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
Cause of treatment discontinuation	1 day	In the subgroup of women who stopped hormone therapy within 5 years following the hormone therapy, determination of the treatment discontinuation.
Continued homonotherapy	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

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre lès Nancy, France