Pelvic Floor Dysfunction in Cancer Survivors.

Completed

• Conditions: Pelvic Floor Dysfunction; Cancer
• Interventions: Other: Application of questionnaires

• Registration Number: NCT03979755
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

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).

Secondary variables:

(A) Sexual function: The Sexual Questionnaire for Urinary Incontinence and Pelvic Organ Prolapse (PISQ-12) evaluated the sexual function and prevalence of sexual dysfunction in the sample (Rogers et al. , 2003; Santana et al., 2012).

(B) Quality of life: The World Health Organization Quality of Life Questionnaire - Brief (WHOQOL-BREF) (Fleck et al., 2000) was used for the evaluation of QoL.

(C) Functional performance: In order to evaluate the functional performance of the sample (real level of human function, self-care capacity and level of ambulation), the Functionality Assessment Flowchart (FAF) developed by Paiva et al 2015.

(D) Influence of PFD on QoL and AVD: The Pelvic Floor Impact Questionnaire (PFIQ-7) was used to assess the impact of PFD on QoL, ADL and emotional health (Barber et al., 2005; Arouca et al., 2016).

Study Timeline

• Study Start: 2019-03-30
• Study First Submitted: 2019-06-02
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Primary Completion: 2019-06-30
• Study Completion: 2019-08-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

Study Group:

• Women living in the city of Campo Belo, Minas Gerais who had cancer in the period between 2013 and 2017.

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Application of questionnaires	Women in routine follow-up in the public health system in Campo Belo, Minas Gerais.
Study Group	Application of questionnaires	Women cancer survivors living in Campo Belo, Minas Gerais.

Primary Outcome Measures

Name	Time	Method
Application of questionnaries	Three months	Application of questionnaries by telephone
Initial screening	Three months	Initial screening of the number of women with cancer in the period between 2013 and 2017

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil