Clinical trial NCT03636776: Quality of Life and Psychological Vulnerability in Patients With RH+ Metastatic Breast Cancer
Official title: Prospective Study to Assess Quality of Life and Psychological Vulnerability in Patients With Metastatic Breast Cancer RH+
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Breast Cancer
Positive Hormonal Receptors
Keywords: Quality of Life
Psychological vulnerability
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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 :

* QLQ-C30 explores 5 functional scales (physical, social, psychological, cognitive functioning, daily activities) and 1 scale of health status and overall quality of life. It allows a detailed analysis of symptoms related to the disease and its treatment (fatigue, nausea/vomiting, pain, dyspnea, loss of appetite, sleep disturbance, constipation and diarrhea) as well as the financial impact for the patient.
* BR23 : specific questionnaire for breast cancer validated in French
* Psychological distress scale (PDS)
* State Trait Anxiety Inventory (STAI) : Assesses the feelings of apprehension, tension, nervousness and worry that the subject feels at the time of the anxiogenic or endangerment situation. This questionnaire is therefore an indicator of transient changes in anxiety caused by aversive or therapeutic situations.
* Beck Depression Inventory (BDI II) : assesses the severity of depression.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline quality of life during breast cancer treatment
timeFrame: 3 years
measure: Change from baseline psychological vulnerability during breast cancer treatment
timeFrame: 3 years
measure: Change from baseline quality of life during breast cancer treatment
timeFrame: 3 years
measure: Change from baseline psychological vulnerability during breast cancer treatment
timeFrame: 3 years
measure: Change from baseline psychological vulnerability during breast cancer treatment
timeFrame: 3 years
Secondary outcomes:
measure: number of therapeutic class treatment prescribed during breast cancer treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Angers
country: France
facility: Ico Angers
city: Saint Herblain
country: France
facility: Ico Nantes
Study officials:
affiliation: ICO NANTES
name: MARIO CAMPONE, MD
role: PRINCIPAL_INVESTIGATOR
References: