Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 :
Studying quality of life over time in patients followed for metastatic breast cancer will identify when a person may feel most vulnerable in their experience of the disease and treatment. A specific and adapted support can thus be set up throughout the disease, from the diagnosis and during the different phases of treatment.
Patients will benefit from a longitudinal follow-up determined according to the treatments. For example :
Chemotherapy : After the first assessment time at 1 month from diagnosis, patients receiving chemotherapy treatment are seen every 3 months.
Hormone therapy : After the first assessment time at 1 month from diagnosis, patients receiving hormone therapy are seen every 2 months.
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.
Patients will complete an end of study visit 3 years after inclusion
Quality of Life and Psychological vulnerability will be assessed through questionnaires :
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quality of life in metastatic BC | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of life in metastatic BC | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline quality of life during breast cancer treatment | quality of life assessed using QLQ-C30 Questionnaire | 3 years |
| Change from baseline psychological vulnerability during breast cancer treatment | Psychological vulnerability assessed using STAI questionnaire | 3 years |
| Change from baseline quality of life during breast cancer treatment | quality of life assessed using BR23 Questionnaire | 3 years |
| Change from baseline psychological vulnerability during breast cancer treatment | Psychological vulnerability assessed using Psychological distress scale. The scale represents a means of assessing the psychological state of patients. The scale measures 10 cm. The patients will have to put a cross on the line at the place which corresponds best to their psychological state of the past week. 0 indicates no distress and 10 very important distress. | 3 years |
| Change from baseline psychological vulnerability during breast cancer treatment | Psychological vulnerability assessed using BDI-II questionnaire | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| number of therapeutic class treatment prescribed during breast cancer treatment | The therapeutic strategy is modified in case of progression: chemotherapy and/or hormonotherapy. This change in treatment can affect the quality of life and psychological vulnerability of patients. The number of therapeutic classes prescribed in this way will make it possible to describe their impact over time on patients' quality of life and psychological vulnerability. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MARIO CAMPONE, MD | ICO NANTES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ico Angers | Angers | 49055 | France | |||
| Ico Nantes |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3 years |
| Saint-Herblain |
| 44805 |
| France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004778 |
| Environment and Public Health |