Clinical trial · Interventional
Quality of Life and Psychological Vulnerability in Patients With RH+ Metastatic Breast Cancer
Prospective Study to Assess Quality of Life and Psychological Vulnerability in Patients With Metastatic Breast Cancer RH+
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The sponsor has set up a secondary competitive study concerning the same population and whose secondary objectives are the same as those of the EPOCA study with the same endpoints.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Positive Hormonal Receptors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of life in metastatic BC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- quality of life in metastatic BC
- description
- Patients benefit from a longitudinal follow-up determined according to the treatments. Each type of treatment has its own schedule based on medical consultation times. At each change of treatment, from chemotherapy to hormone therapy or vice versa, the assessment times are determined according to the nature of the treatment. The rhythm of the evaluation visits will therefore be defined by the doctor, according to the habits of the centre. The evaluation times used to collect the questionnaires (QLQ-C30, BR23, PDS, STAI, BDI II).
- interventionNames
- Other: Quality of life in metastatic BC
Primary outcomes (5)
- measure
- Change from baseline quality of life during breast cancer treatment
- timeFrame
- 3 years
- description
- quality of life assessed using QLQ-C30 Questionnaire
- measure
- Change from baseline psychological vulnerability during breast cancer treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed diagnosis of invasive breast cancer (=infiltrant). NB: Mixed histologies are allowed 2. Adult women (≥ 18 years), 3. Positive hormonal receptors (Estrogen receptors and/or Progesterone receptors ≥10%) and HER2 negative 4. Patient in need of a 1st metastatic treatment line NB: Patients may have received prior treatment for their cancer, but not for their metastatic disease. 5. Performance status ≤ 1 (world health organization) 6. Patients affiliated to a Social Security, 7. Obtaining the patient's signed written consent Exclusion Criteria: 1. Patient with non-metastatic breast cancer, 2. man 3. Negative hormonal receptors or HER2 positive 4. Psychiatric history with specialist diagnosis 5. Pregnant or nursing patient 6. Patients who cannot be followed regularly for psychological reasons (cognitive problems preventing completion of questionnaires), or because of geographical remoteness. 7. Person deprived of liberty or adult under guardianship
References
Publications (0)
Data not yet available