Quality of Life and Psychological Vulnerability in Patients With RH+ Metastatic Breast Cancer

NCT03636776 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-29

No results posted yet for this study

Summary

Metastatic breast cancer (MBC) is a dark prognostic disease with survival at 5 years of less than 20% and a median survival of 24 to 30 months after diagnosis of metastasis. Thus, metastatic diagnosis can be expected to have a different impact on the quality of life of patients in early and advanced stages.

However, MBC benefits from therapeutics that improve patients' quality of life and even improve overall survival. The main objectives of this prospective study are :

* to evaluate the evolution over time of the quality of life of patients treated for positive hormonal receptors (RH+) metastatic breast cancer, according to the therapeutic class ;
* to evaluate the psychological vulnerability of these patients since the announcement of their metastatic diagnosis and during their treatments. Finally, when interviewing oncologists, to know the factors involved in a treatment change decision process for the same patient.

Conditions

Interventions

OTHER

Quality of life in metastatic BC

1 month after metastatic stage diagnosis, patients complete their 1st therapeutic sequence evaluation visit (T1) within the recommended standard time frames. If the disease remains stable or if a response to treatment is observed then patients continue their follow-up in the same therapeutic sequence (T1). If progression occurs, treatment is modified and patients move on to the next therapeutic sequence (T2). And so on as many times as necessary. Before each evaluation visit with investigator, patients complete the questionnaires QLQ-C30, BR23, STAI, BDI II

Sponsors & Collaborators

  • Institut Cancerologie de l'Ouest

    lead OTHER

Principal Investigators

  • MARIO CAMPONE, MD · ICO NANTES

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-29
Primary Completion
2022-01-11
Completion
2022-01-11

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636776 on ClinicalTrials.gov