Clinical trial NCT02862990: Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk of Fertility Loss Caused by Chemotherapy
Official title: Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Fertility
Keywords: Breast cancer
Fertility
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Grupo de Estudios Clínicos Oncológicos Peruano
First posted: 2016-08-11
Enrollment: 343
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre menopausal women diagnosed with breast cancer prior treatment

Brief summary: To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.

Detailed description: To characterize the attitude of pre menopausal patients with breast cancer regarding the risks of infertility based on the following variables:

* Age at diagnosis
* Number of children
* Will of having children
* Marital status
* Scholarity
* Period of time from the diagnosis
* Time of the last menstruation period
* Chemotherapy administration
* Clinical staging at the diagnosis
* Pathological evaluation
* Documentation of the cancer therapy

Eligibility criteria: Inclusion Criteria:

* Women with age ≥ 18 and ≤ 40
* Indication of (neo) adjuvant chemotherapy
* Prior chemotherapy treatment
* Patients with menstrual periods in the last 6 months
* In use of contraceptive methods
* Without breast cancer recurrence
* Capacity to read and understand the informed consent

Exclusion Criteria:

* Patients which received or with indication of definitive ovarian suppression (surgery and/or radiotherapy), except temporary pharmacological ovarian suppression
* Patients whom initiated chemotherapy treatment before entering the study
* Altered state of mind, dementia, or any other psychiatry problem that can interfere in the comprehension or interpretation of the informed consent.
* Previous diagnosis of infertility

Primary outcomes:
measure: To analyze the number of pre-menopausal patients diagnosed with breast cancer that did not agree in receiving chemotherapy due to the risk of infertility
timeFrame: Baseline and 1 year after after the first interview
Secondary outcomes:
measure: Infertility risk for breast cancer patients after accepting chemotherapy
timeFrame: Baseline and 1 year after the first interview
measure: Minimal percentage of cure necessary for patients accept the chemotherapy treatment
timeFrame: Baseline and 1 year after the first interview
measure: Age when diagnosed
timeFrame: Baseline and 1 year after the first interview
measure: Number of children
timeFrame: Baseline and 1 year after the first interview
measure: Desire to have kids
timeFrame: Baseline and 1 year after the first interview
measure: Marital status
timeFrame: Baseline
measure: Scholarity
timeFrame: Baseline
measure: Period of time since the diagnosis
timeFrame: Baseline
measure: Chemotherapy scheme administration
timeFrame: Baseline and 1 year after the first interview
measure: Period of time from the last menstruation period
timeFrame: Baseline and 1 year after the first interview
measure: Description of quality of life of patients with the EORTC QLQ-BR23
timeFrame: Baseline and 1 year after the first interview
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: CPO - Pucrs
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: HCPA
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Hospital Pérola Byington
city: Havana
country: Cuba
facility: Instituto Nacional de Oncologia y Radiobiologia
city: Toluca de Lerdo
country: Mexico
facility: Cenro Oncologico Estatal ISSEMYM
city: Surquillo
country: Peru
facility: INEN
city: Puerto Cabello
country: Venezuela
facility: Hospital de Clínicas San Agustín
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky, MD
role: STUDY_DIRECTOR
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