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Breast cancer directly affects women physically, psychologically and socially in the process of diagnosis, treatment and post-treatment. Despite the improvement in conventional breast cancer treatments that led to longer disease-free survival, many patients still suffer from physical, psychological, social and spiritual problems after treatment. The neglect of physical and psychosocial problems faced by patients who are between 1 and 2 years after the end of treatment negatively impacts the quality of life of this population.
The purpose of the study is to assess the overall quality of life and measure the impact on women who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment and to identify possible repercussions of breast cancer and its treatments associated with Quality of Life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Survivors | Women who have survived breast cancer for at least 1 year (12 months) and 2 years (24 months) after the end of primary treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of life in Breast Cancer Survivors | Behavioral | The patient will receive the following questionnaires to be completed :
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Health Status by EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire) | This questionnaire was designed to be cancer specific, and includes all emotional, social and physical aspects of the individual's life. The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum. | 1 year after treatment ends; 2 years after treatment ends; |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life specific for breast cancer by EORTC QLQ-BR23 (European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire) | The questionnaire contains 23-item, two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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Recruitment of 100 breast cancer patients who have completed treatment within a minimum of 1 year and are currently undergoing outpatient follow-up
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thiago Brito, MD | Contact | +55 21 97154-0865 | tcgvidal@hotmail.com | |
| Alayne Domingues Yamada, PhD | Contact | +55 11 98141-7613 | alayne.pesquisa@ibcc-mooca.org.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IBCC Oncologia | Recruiting | São Paulo | 03102002 | Brazil |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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| 1 year after treatment ends; 2 years after treatment ends; |
| Quality of life by FACT-B+4 (Functional Assessment of Cancer Therapy-Breast) | The FACT-B+4 questionnaire (Functional Assessment of Cancer Therapy-Breast) consists of 40 questions: 27 about general quality of Life and 13 about breast cancer. It is fur-ther structured into five subscales: physical, family-social, emotional, functional well-being and a last part specific for breast cancer. The result given by the sum of the scores goes from zero to 164: a higher score corresponds to major well-being of the patient. | 1 year after treatment ends; 2 years after treatment ends; |
| D004778 |
| Environment and Public Health |