- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03979755
Pelvic Floor Dysfunction in Cancer Survivors.
Pelvic Floor Dysfunction in Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14040-900
- University of Sao Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Study Group: women surviving cancer residing in the municipality of Campo Belo, Minas Gerais, with prior cancer treatment and diagnosis confirmed by histopathology in the last five years (2013-2017).
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, with pathologies not associated positively or negatively with the exposures of interest of the study. The controls do not present a present or previous clinical history of cancer.
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Group
Women cancer survivors living in Campo Belo, Minas Gerais.
|
Application of questionnaires described by telephone.
|
Control Group
Women in routine follow-up in the public health system in Campo Belo, Minas Gerais.
|
Application of questionnaires described by telephone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initial screening
Time Frame: Three months
|
Initial screening of the number of women with cancer in the period between 2013 and 2017
|
Three months
|
Application of questionnaries
Time Frame: Three months
|
Application of questionnaries by telephone
|
Three months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
- Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
- Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. doi: 10.1007/s00192-003-1063-2. Epub 2003 Jul 25. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2004 May-Jun;15(3):219.
- Arouca MA, Duarte TB, Lott DA, Magnani PS, Nogueira AA, Rosa-E-Silva JC, Brito LG. Validation and cultural translation for Brazilian Portuguese version of the Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress Inventory (PFDI-20). Int Urogynecol J. 2016 Jul;27(7):1097-106. doi: 10.1007/s00192-015-2938-8. Epub 2016 Jan 19.
- Fitz FF, Santos ACC, Stüpp L, Bernardes APMR, Marx AG. Impacto do tratamento do cancer de colo uterino no assoalho pélvico. FEMINA. 2011;39(8):387-93.
- Muir CS. Cancer Incidence in Five Continents. Classification. IARC Sci Publ. 1992;(120):25-30. No abstract available.
- Instituto Nacional de Câncer José Alencar Gomes da Silva. Coordenação de Prevenção e Vigilância. Estimativa 2018: incidência de câncer no Brasil / Instituto Nacional de Câncer José Alencar Gomes da Silva. Coordenação de Prevenção e Vigilância. Rio de Janeiro: INCA, 2017.
- Paiva CE, Siquelli FA, Santos HA, Costa MM, Massaro DR, Lacerda DC, Nunes JS, de Padua Souza C, Paiva BS. The Functionality Assessment Flowchart (FAF): a new simple and reliable method to measure performance status with a high percentage of agreement between observers. BMC Cancer. 2015 Jul 5;15:501. doi: 10.1186/s12885-015-1526-0.
- Santana GW, Aoki T, Auge AP. The Portuguese validation of the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J. 2012 Jan;23(1):117-21. doi: 10.1007/s00192-011-1505-1. Epub 2011 Jul 28.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 3.358.945
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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