Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03470935
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2017-10-23
Brief Title:
Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger
Sponsor:
Hôpital Privé des Côtes dArmor HPCA
Organization:
Hôpital Privé des Côtes dArmor HPCA
Study Overview
Official Title:
A Non-interventional Study Evaluating the Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger Than 40 Years ARTEMIS
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTEMIS
Brief Summary:
Brest cancer is the most common cancer in women in France with 52000 new cases diagnosed in 2010 including nearly 6000 women younger than 40
The improvement of the fertility conservation of cancer patients is one of the goals put forward by the french Cancer Plan Objective 81
The issue of fertility after a breast cancer is a frequently raised subjects by the concerned couples today The improvement in prognosis due to therapeutic advances combined with the increasing age of the first pregnancy and in the recomposed couples bring number of young women between 35 and 40 years followed for breast cancer today to raise these questions with their oncologists
Young women have a greater risk to develop agressive tumors requiring a mulitimodal treatment whose general and gonadic side effects can be important and permanently impact the reproductive capacity At the time of diagnosis almost 50 of these young patients report that they want to consider a later pregnancy but no data are available on the evolution of this wish over time although it is known that anti-cancer treatments have a serious impact on future possibilities of pregnancys
The sequential chemotherapy regimen prescribed in adjuvant or neo-adjuvant situation includes intercaling agents antracyclines and an alkylating agent cyclophosphamide partially responsible for subsequent fertility disorders In addition a chemotherapy-induced amenorrhea CAI occurs in 50 to 80 of women according to the studies the latter is sometines definitive and sequellar of treatment However few data describe the time of recovery of menstrual cycles in women with CAI and subsequent impact of fertility
The aim of this study is to evaluate the impact of cancer diagnosis and treatment on the wishes of fertility before and after the management of cancer of the patients in question on the recovery of menstrual cycles and the quality of sexual life of these patients
The investigators hope to improve the pre-therapeutic evaluation of women wishing to implement measures to preserve fertility to assist women wishing to consider this type of project after cytotoxic treatments and accompany women suffering from a change in self-image that has an impact on their quality of life These results could help to sensitize the doctors to the difficulties encountered by young women and to improve andor to strengthen the global and adapted care of these patients
The improvement of the fertility conservation of cancer patients is one of the goals put forward by the french Cancer Plan Objective 81
The issue of fertility after a breast cancer is a frequently raised subjects by the concerned couples today The improvement in prognosis due to therapeutic advances combined with the increasing age of the first pregnancy and in the recomposed couples bring number of young women between 35 and 40 years followed for breast cancer today to raise these questions with their oncologists
Young women have a greater risk to develop agressive tumors requiring a mulitimodal treatment whose general and gonadic side effects can be important and permanently impact the reproductive capacity At the time of diagnosis almost 50 of these young patients report that they want to consider a later pregnancy but no data are available on the evolution of this wish over time although it is known that anti-cancer treatments have a serious impact on future possibilities of pregnancys
The sequential chemotherapy regimen prescribed in adjuvant or neo-adjuvant situation includes intercaling agents antracyclines and an alkylating agent cyclophosphamide partially responsible for subsequent fertility disorders In addition a chemotherapy-induced amenorrhea CAI occurs in 50 to 80 of women according to the studies the latter is sometines definitive and sequellar of treatment However few data describe the time of recovery of menstrual cycles in women with CAI and subsequent impact of fertility
The aim of this study is to evaluate the impact of cancer diagnosis and treatment on the wishes of fertility before and after the management of cancer of the patients in question on the recovery of menstrual cycles and the quality of sexual life of these patients
The investigators hope to improve the pre-therapeutic evaluation of women wishing to implement measures to preserve fertility to assist women wishing to consider this type of project after cytotoxic treatments and accompany women suffering from a change in self-image that has an impact on their quality of life These results could help to sensitize the doctors to the difficulties encountered by young women and to improve andor to strengthen the global and adapted care of these patients
Detailed Description:
Selection criteria
1 Patient with non-metastatic breast cancer
2 Age of patient between 18 and 40 years at histological diagnosis
3 Patient treated with neoadjuvant or adjuvant chemotherapy with or without radiotherapy or endocrine therapy
4 Patient who have completed their chemotherapy andor radiotherapy treatment for at least 3 months at the time of questionnaire dispatch
5 Patient informed of the study patient must have received the informed consent document and doesnt opposed to it and who answered to the specific questionnaire of the study
Main objective
Describe the impact of diagnosis and the breast cancer care on fertility in patients younger than 40 years
Secondary objectives
Describe the patient population age type of histological grade treatments
Describe the recovery of menstrual cycle after chemotherapy occurrence of menstrual cycles and regularity
Describe fertility after treatment
Describe the sexual impact adverse events related to diagnosis and therapeutic care through an optional part of questionnaire
Describe the impact of breast cancer diagnosis on the couples life
Describe the impact on body image body image satisfaction breast reconstruction
1 Patient with non-metastatic breast cancer
2 Age of patient between 18 and 40 years at histological diagnosis
3 Patient treated with neoadjuvant or adjuvant chemotherapy with or without radiotherapy or endocrine therapy
4 Patient who have completed their chemotherapy andor radiotherapy treatment for at least 3 months at the time of questionnaire dispatch
5 Patient informed of the study patient must have received the informed consent document and doesnt opposed to it and who answered to the specific questionnaire of the study
Main objective
Describe the impact of diagnosis and the breast cancer care on fertility in patients younger than 40 years
Secondary objectives
Describe the patient population age type of histological grade treatments
Describe the recovery of menstrual cycle after chemotherapy occurrence of menstrual cycles and regularity
Describe fertility after treatment
Describe the sexual impact adverse events related to diagnosis and therapeutic care through an optional part of questionnaire
Describe the impact of breast cancer diagnosis on the couples life
Describe the impact on body image body image satisfaction breast reconstruction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None