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临床试验/NCT05109468
NCT05109468已完成不适用

Assessment of Patients' Quality of Sexual Life After Anal Cancer Treatment

Institut du Cancer de Montpellier - Val d'Aurelle1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年6月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Change in Sexual quality of life score

研究概览

简要总结

The purpose of this this study, to evaluate the quality of sexual life of patients treated for anal cancer treated by radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after treatment. cancer diagnosis.

详细描述

Sexual health is defined by WHO in 2011 as a state of physical, emotional, mental and social well-being in relation to sexuality. It is an integral part of health, well-being and quality of life and is recognized as a right of everyone.Alteration of sexuality after cancer impacts all phases of the sexual response. It is multifactorial: psychological (ie, anxiety linked to the disease, fear of death, or impairment of body image) and physiological (ie, alteration of the sexual reaction which may be linked, in part, to direct sequelae generated by irradiation of the genitals).

Anal cancer remains fairly rare, affecting around 2,200 people each year in France, with a predominance of women (60 to 70% of patients), However, its incidence has been growing strongly for 30 years, in Europe and the United States where it is has increased by 70% over the last 10 years alone, in both men and women, with an increasingly younger population.

It is linked, in more than 90% of cases, to a carcinogenic virus, the Human PapillomaVirus (HPV), a late consequence of an infection, most often asymptomatic, transmitted by the sexual route.

The question of sexuality after cancer remains, in fact, very little addressed by doctors who express a lack of training. Patients, for their part, often do not dare to raise the issue with caregivers, out of modesty, or thinking that the teams do not have the time. Discussions with patients therefore generally always remain focused on oncological management, from the initial consultation to the follow-up consultations. The hope of recovery awaited on each of the assessments and the fear of relapse often obscure more global and equally essential questions: whether it is about the quality of life, the after-effects, or even more, the quality. of sex life. For these reasons, this study will collect the information provided to patients on the impact of this treatment on their sexual health, whether it is medical information recorded in the file, or information perceived and retained by patients.

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
All
接受健康志愿者

入选标准

  • Age> 18 years old.
  • Patient treated for non-metastatic squamous cell anus cancer with the presence of an HPV infection authenticated on the biopsy.
  • Patient living with a partner or having an active sex life the year preceding the diagnosis.
  • Patient who, after information, agrees to participate in the study.
  • Patient affiliated to a French social security scheme.

排除标准

  • Patient unable or unwilling to complete a questionnaire on the quality of sexual life.
  • Patient without sexual activity the year before diagnosis.
  • Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons.
  • Patient under guardianship, curatorship or legal protection.

研究组 & 干预措施

Anal cancer patients

Non-metastatic squamous anus cancer with the presence of an HPV infection authenticated on the biopsy

干预措施: Quality of life questionnaire (Other)

结局指标

主要结局

Change in Sexual quality of life score

时间窗: at inclusion, 3 months post-treatment and 2 years after the announcement of cancer.

Sexual quality of life score obtained on the European EORTC SHQ-C22 questionnaire

次要结局

未报告次要终点

研究者

发起方
Institut du Cancer de Montpellier - Val d'Aurelle
申办方类型
Other
责任方
Sponsor

研究点 (1)

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