NCT03979755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

June 2, 2019

Last Update Submit

September 12, 2019

Conditions

CancerPelvic Floor Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Initial screening

    Initial screening of the number of women with cancer in the period between 2013 and 2017

    Three months

  • Application of questionnaries

    Application of questionnaries by telephone

    Three months

Study Arms (2)

Study Group

Women cancer survivors living in Campo Belo, Minas Gerais.

Other: Application of questionnaires

Control Group

Women in routine follow-up in the public health system in Campo Belo, Minas Gerais.

Other: Application of questionnaires

Interventions

Application of questionnairesOTHER

Application of questionnaires described by telephone.

Control GroupStudy Group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, 14040-900, Brazil

Location

Related Publications (10)

  • 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.

    PMID: 26782099BACKGROUND

  • 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.

    PMID: 16021067BACKGROUND

  • 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.

    PMID: 25220842BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 10881154BACKGROUND

  • INTERNATIONAL AGENCY OF RESEARCH ON CANCER. Cancer Incidence in Five Continents, Lyon: IARC Scientific Publications, 1992.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 26142726BACKGROUND

  • 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.

    PMID: 12955337BACKGROUND

  • 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.

    PMID: 21796471BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 2, 2019

First Posted

June 7, 2019

Study Start

March 30, 2019

Primary Completion

June 30, 2019

Study Completion

August 30, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)