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Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. Curiously, no study to date has been submitted or published about how women with a one-year treatment "extra" Herceptin ® live this period in terms of quality of life, in terms of psychological impact for themselves and their families.
The investigators have no more data on how often they return to work during this treatment or on the psycho-social parameters which underpin them. It therefore seemed interesting to "give a spotlight" on this particular period in these women HER2 + by comparing a patient population of same age receiving the same adjuvant but with no Herceptin ®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients group with Herceptin | Experimental | Patients beginning Herceptin in adjuvant after chemotherapy |
|
| Control group | Active Comparator | patient not beginning Herceptin after chemotherapy : control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires | Other | delivery of questionnaires and self-psychological interview |
|
| Measure | Description | Time Frame |
|---|---|---|
| score of fatigue | The main objective of this study is to evaluate the score of fatigue in patients with HER2 overexpressing breast cancer and for whom Herceptin ® treatment is prescribed, compared with a population of patients treated with the same age the same chemotherapy without Herceptin ®. | at 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the quality of life | Assess the quality of life of patients treated for breast cancer with surgery followed by adjuvant chemotherapy (+/-hormonotherapy) associated with treatment with Herceptin ®, compared with patients of similar age treated with the same chemotherapy without Herceptin ® | 3, 6, 9 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinne DELCAMBRE, MD | Centre François Baclesse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre François BACLESSE | Caen | Calvados | 14076 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| questionnaires | Other | delivery of questionnaires and self-psychological interview |
|
| Impact of Herceptin ® in the professional lives |
Assess the impact of Herceptin ® in the professional lives of patients, compared to patients not treated with Herceptin ®. Evaluation done by a specific questionnaire on professional lives, a scoring will be determined. |
| at 3, 6 ,9 and 12 months |
| quantitative and qualitative psychological impact of Herceptin ® | Assess the quantitative and qualitative psychological impact of Herceptin ® in patients so treated, compared to patients not treated with Herceptin ®. Evaluation done by specific questionnaires, a scoring will be determined. | at 3 months |
| a qualitative sociological analysis among spouses of patients | Conduct a qualitative sociological analysis among spouses of patients treated with Herceptin ®. An interview with a sociologist will be done and characteristic sociologic of patients will be described. | at 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |