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临床试验/NCT02949596
NCT02949596已完成不适用

Prospective Cohort on Quality of Sexual Life Among Men Who Have Sex With Men Treated for Anal Cancer With Concurrent Chemotherapy and Intensity-modulated Radiotherapy

Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Evaluate quality of life validated questionnaire (EORTC QLQ-30) among patients treated for anal cancer with concurrent chemoradiotherapy who are men who have sex with other men

研究概览

简要总结

Treatment of anal cancer has been always linked to quality of life. Recently, with development on radiotherapy technique, toxicities have been lowered with the maintenance of adequate rates of disease control. This trial intends to follow patients prospectively with questionnaires to evaluate sexual quality of life among patients who are who men who have sex with other men and have been subject to concurrent chemoradiotherapy with IMRT technique.

详细描述

In this prospective single-arm cohort, patients who are men who have sex with other men will be recruited to answer routine questionnaires on quality of life in general and sexual quality of life in specific, most validated and other waiting for validation in Portuguese language. These questionnaires will be applied after the diagnose and before the beginning of the treatment, on the last day of treatment, and 3, 6 and 12 months after the treatment is completed. Only patients who will be treated with concurrent chemotherapy will be recruited, and intensity-modulated radiotherapy technique is mandatory.

研究设计

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

入排标准

性别
Male
接受健康志愿者

入选标准

  • Anal cancer proven biopsy
  • men who have sex with other men
  • curative intent of treatment
  • IMRT required
  • concurrent chemotherapy required

排除标准

  • Patients who have undergone surgery for anal cancer
  • patients who can't read, write or are unable to answer to questionnaire

结局指标

主要结局

Evaluate quality of life validated questionnaire (EORTC QLQ-30) among patients treated for anal cancer with concurrent chemoradiotherapy who are men who have sex with other men

时间窗: 2015-2020

Evaluate quality of life validated questionnaire (SF-36) among patients treated for anal cancer with concurrent chemoradiotherapy who are men who have sex with other men

时间窗: 2015-2020

Evaluate quality of sexual life validated questionnaire (IIEF) among patients treated for anal cancer with concurrent chemoradiotherapy who are men who have sex with other men

时间窗: 2015-2020

次要结局

  • Evaluate quality of sexual life with other questionnaires (SEAR) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (ISL) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (MSHQ-short version) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (CAYA-t) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (CSFQ-14) that are not validated in Portuguese language in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (SEX-Q) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (SHIM) in the same population(2015-2020)
  • Evaluate quality of life among patients who are HIV positive in this cohort with the use of questionnaire HAT-QoL(2015-2020)

研究者

发起方
Instituto do Cancer do Estado de São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Geovanne Pedro Mauro

MD

Instituto do Cancer do Estado de São Paulo

研究点 (1)

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