Pelvic Floor Dysfunction in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Application of questionnaries
研究概览
简要总结
Introduction: Pelvic floor dysfunctions (PFD) represent a major public health problem manifested through lower urinary tract symptoms (LUTS), anorectal and sexual dysfunction. PFD is a common problem in cancer survivors with a negative impact on quality of life (QoL). However, the magnitude of its prevalence in women with no history of cancer is unknown. Aims: To verify the prevalence of PFD among cancer survivors. Secondly, to evaluate sexual function, QoL and functional performance of women cancer survivors and the influence of PAD on QoL, ADL and emotional health. Methods: Two group is being conducted. Study Grourp (SG) are women diagnosed with any neoplasia in the period between 2013 and 2017 living in the municipality of Campo Belo / MG. Control Group (CG) are women in routine clinical follow-up at the units of the Family Health Program of that city, with no history of cancer. All volunteers will be interviewed by telephone through the application of a structured questionnaire that assesses socioeconomic indicators, gynecological-obstetric history and life habits, as well as specific questionnaires for the evaluation of PFD, functional performance and QoL.
详细描述
Data collect: The lists of women residing in Campo Belo / MG, with and without a history of cancer, were used by the Municipal Health Department (MDH). Data on cancer treatment may also be used, if they are in the field of MDH. The information used in this study originated in a questionnaire developed for the study that included socioeconomic indicators, gynecological-obstetric history and life habits (smoking, alcohol consumption and sedentary lifestyle). All interviews were conducted by telephone. Other questionnaires were also used, all translated and validated for Brazilian Portuguese.
SG and CG groups were matched for age and parity. Age information was collected continuously and grouped into class intervals from the age of 20, resulting in strata for analysis with cohort points at 20, 30, 40, 50, 60, 70 and 80 years. Parity was divided into five categories according to the parity: nulliparous, 1 delivery, 2 delivery, 3 delivery, 4 or more deliveries.
Variables
Primary variable:
(A) Prevalence of PFD: The Pelvic Floor Disability Index (PFDI-20) was used to evaluate the prevalence and symptomatology of pelvic organ prolapse (POP), anorectal symptoms and urinary incontinence (UI) (Barber et al., 2005; Arouca et al., 2016).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Study Group:
- •Women living in the city of Campo Belo, Minas Gerais who had cancer in the period between 2013 and
- •Control Group:
- •Women in routine follow-up in the public health network through the units of the Family Health Program of the city of Campo Belo, Minas Gerais, without previous clinical history of cancer.
排除标准
- •Women that have more than one tumor;
- •Women with metastatic disease;
- •Women do not have the physical and mental conditions to respond to the interviews;
- •No acceptance or consent to participate in the survey.
结局指标
主要结局
Application of questionnaries
时间窗: Three months
Application of questionnaries by telephone
Initial screening
时间窗: Three months
Initial screening of the number of women with cancer in the period between 2013 and 2017
次要结局
未报告次要终点
研究者
Aline Moreira Ribeiro
Principal Investigator
University of Sao Paulo