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

• ClinicalTrials.gov Identifier: NCT03636776
• Recruitment Status: Unknown
• First Posted: August 17, 2018
• Last Update Posted: August 31, 2018
• Sponsor: Institut Cancerologie de l'Ouest
• Information provided by (Responsible Party): Institut Cancerologie de l'Ouest

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metastatic Breast Cancer; Positive Hormonal Receptors	Other: Quality of life in metastatic BC	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Prospective Study to Assess Quality of Life and Psychological Vulnerability in Patients With Metastatic Breast Cancer RH+
• Actual Study Start Date: December 29, 2016
• Estimated Primary Completion Date: December 28, 2021
• Estimated Study Completion Date: December 28, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: quality of life in metastatic BC; 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).

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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline quality of life during breast cancer treatment [ Time Frame: 3 years ]
   quality of life assessed using QLQ-C30 Questionnaire
2. Change from baseline psychological vulnerability during breast cancer treatment [ Time Frame: 3 years ]
   Psychological vulnerability assessed using STAI questionnaire
3. Change from baseline quality of life during breast cancer treatment [ Time Frame: 3 years ]
   quality of life assessed using BR23 Questionnaire
4. Change from baseline psychological vulnerability during breast cancer treatment [ Time Frame: 3 years ]
   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.
5. Change from baseline psychological vulnerability during breast cancer treatment [ Time Frame: 3 years ]
   Psychological vulnerability assessed using BDI-II questionnaire

Secondary Outcome Measures :

1. number of therapeutic class treatment prescribed during breast cancer treatment [ Time Frame: 3 years ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: MARIO CAMPONE, MD; +332 40 67 99 00 ext 2909; mario.campone@ico.unicancer.fr

Contact: ANGELIQUE BONNAUD; +332 40 67 99 00 ext 9138; angelique.bonnaud@ico.unicancer.fr

Locations

France

Ico Angers; Recruiting

Angers, France, 49055

Contact: PAULE AUGEREAU, MD +332 41 35 37 22 ext 4822 paule.augereau@ico.unicancer.fr

Principal Investigator: PAULE AUGEREAU, MD

Ico Nantes; Recruiting

Saint Herblain, France, 44805

Contact: MARIO CAMPONE, MD +332 40 67 99 00 ext 2909 mario.campone@ico.unicancer.fr

Contact: ANGELIQUE BONNAUD +332 40 67 99 00 ext 9138 angelique.bonnaud@ico.unicancer.fr

Principal Investigator: MARIO CAMPONE, MD

Sponsors and Collaborators

Institut Cancerologie de l'Ouest

Investigators

• Principal Investigator: MARIO CAMPONE, MD; ICO NANTES

More Information

• Responsible Party: Institut Cancerologie de l'Ouest
• ClinicalTrials.gov Identifier: NCT03636776
• Other Study ID Numbers: ICO-N-2015-04
• First Posted: August 17, 2018
• Last Update Posted: August 31, 2018
• Last Verified: August 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Cancerologie de l'Ouest:

Quality of Life; Psychological vulnerability

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases