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临床试验/NCT05577156
NCT05577156已完成不适用

Sexual Quality of Life and Metastatic Breast Cancer

Institut de Cancérologie de Lorraine1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Assessment of sexual quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment

研究概览

简要总结

The study is composed of three paper self-questionnaires to be filled in by the patients included at distance (> 6 months) from their diagnosis of metastatic breast cancer, in order to limit the impact of the announcement on the filling out the questionnaires.

After verification of the eligibility criteria, the medical oncologist will present the study to patients coming to the ICL for a follow-up consultation as part of their regular care. The patients will meet with a clinical research nurse so that she can explain the again and answer any questions they may have. She will also give the patients the questionnaires questionnaires and will give a presentation of the questions asked. After this meeting, the patients will be given sufficient time to reflect on, which may extend until their next visit to the ICL, in order to express, if they wish, their opposition to participating in the study. If she agrees to participate, the patient can then complete the questionnaires as well as the complementary questionnaire and place them in a closed envelope to be given to the clinical research nurse. The completion of the questionnaires will be completely anonymous. The data of those who object to the use of their data will be deleted from the database.

After the completion of the questionnaires, and in order to allow a benefit for the patient, a semi-directive interview in the form of a teleconsultation with a psycho-oncologist and sexologist will be offered. The interviews are not mandatory.

The time to fill in the self-questionnaires is estimated at 30 minutes and the semi-directive interview can last up to one hour. Finally, at the end of the study, as part of her subsequent care, each patient participating in the study will have the possibility to renew a teleconsultation with the psycho-oncologist and sexologist if she feels the need. As the subject of the study may generate personal questions and lead to a request for psychological and/or sexological care.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Major woman
  • Patient with metastatic breast cancer, either initially or secondary metastatic breast cancer
  • RH+/HER2- tumor
  • Patient starting first line metastatic therapy or currently undergoing 1st line metastatic treatment
  • Patient diagnosed with metastatic breast cancer 6 months or more
  • WHO 1 or 2 patient
  • Postmenopausal or not
  • Patient able to understand the French language

排除标准

  • Patient WHO>2
  • Patient undergoing chemotherapy
  • HER2+ or triple negative tumor
  • Patient diagnosed with breast cancer less than 6 months ago
  • Patient under guardianship, curatorship or safeguard of justice

结局指标

主要结局

Assessment of sexual quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment

时间窗: Day 0

Patients will fill the questionnaire : BISF-W (Brief Index of Sexual Function for Women)

次要结局

  • Assessment of overall quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment(Day 0)
  • Assessment of sexual and emotional intimacy(Day 0)

研究者

发起方
Institut de Cancérologie de Lorraine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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