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临床试验/NCT06018376
NCT06018376已完成不适用

Characteristics of Sexual Dysfunction in Patients With Lung Cancer

Fundación GECP29 个研究点 分布在 5 个国家目标入组 553 人开始时间: 2023年7月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
553
试验地点
29
主要终点
Number of Participants With Different Type, Frequency and Severity of Sexual Dysfunction

研究概览

简要总结

The general objective of this observational study is identify and describe the type, frequency, and severity of sexual dysfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population. The recruitment will be carried out from July 2023 and will be carried out until December 2023, the analysis of the information will be carried out from January to March 2024.

详细描述

It is planned to develop a study with a larger number of patients with lung cancer, including the population of Spain and Latin American countries to obtain a sample of more diverse and heterogeneous characteristics, with clinical, cultural, and sociodemographic differences. This will make it possible to obtain better and greater data and therefore define the clinical and treatment factors significantly associated with DS in these individuals and obtain a more complete vision of the reality of the problem.

The results of this research will make it possible to carry out interventions specifically directed at this population and to modify the oncological follow-up guidelines currently in force. Likewise, the information collected will serve as the basis for generating new protocols for a multidisciplinary approach, including the participation of psychology and specialists in urology, gynecology, and psychiatry.

The general objective of this observational study is identify and describe the type, frequency, and severity of sexual dysfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population. The recruitment will be carried out from July 2023 and will be carried out until December 2023, the analysis of the information will be carried out from January to March 2024.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years and less than or equal to 70 years.
  • Diagnosis of lung cancer stages IB to IV.
  • Having received systemic oncological treatment for at least 3 months or being in oncological follow-up after having received systemic treatment for a minimum of 3 months with stable tumor disease or partial or complete response in images.

排除标准

  • Patients with comorbidities (renal failure, cardiovascular diseases or similar) not controlled with corresponding medical management.
  • Individuals with physical disability or cognitive impairment that prevents them from completing the electronic data collection form.

研究组 & 干预措施

Observational Study Group

  • Age greater than or equal to 18 years and less than or equal to 70 years.
  • Diagnosis of lung cancer stages IB to IV.
  • Having received systemic oncological treatment for at least 3 months
  • ECOG ≤ 2

干预措施: Systemic oncological treatment (Drug)

结局指标

主要结局

Number of Participants With Different Type, Frequency and Severity of Sexual Dysfunction

时间窗: From inclusion up to 3 months

Identify and describe the type, frequency, and severity of sexual disfunction in patients with lung cancer and generate strategies for clinical management and oncological follow-up directed and based on the specific findings in this population.

次要结局

未报告次要终点

研究者

发起方
Fundación GECP
申办方类型
Other
责任方
Sponsor

研究点 (29)

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