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Clinical Trials/NCT02949596
NCT02949596
Completed
Not Applicable

Prospective Cohort on Quality of Sexual Life Among Men Who Have Sex With Men Treated for Anal Cancer With Concurrent Chemotherapy and Intensity-modulated Radiotherapy

Instituto do Cancer do Estado de São Paulo1 site in 1 country19 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anal Cancer
Sponsor
Instituto do Cancer do Estado de São Paulo
Enrollment
19
Locations
1
Primary Endpoint
Evaluate quality of life validated questionnaire (EORTC QLQ-30) among patients treated for anal cancer with concurrent chemoradiotherapy who are men who have sex with other men
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Treatment of anal cancer has been always linked to quality of life. Recently, with development on radiotherapy technique, toxicities have been lowered with the maintenance of adequate rates of disease control. This trial intends to follow patients prospectively with questionnaires to evaluate sexual quality of life among patients who are who men who have sex with other men and have been subject to concurrent chemoradiotherapy with IMRT technique.

Detailed Description

In this prospective single-arm cohort, patients who are men who have sex with other men will be recruited to answer routine questionnaires on quality of life in general and sexual quality of life in specific, most validated and other waiting for validation in Portuguese language. These questionnaires will be applied after the diagnose and before the beginning of the treatment, on the last day of treatment, and 3, 6 and 12 months after the treatment is completed. Only patients who will be treated with concurrent chemotherapy will be recruited, and intensity-modulated radiotherapy technique is mandatory.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
February 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Instituto do Cancer do Estado de São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Geovanne Pedro Mauro

MD

Instituto do Cancer do Estado de São Paulo

Eligibility Criteria

Inclusion Criteria

  • Anal cancer proven biopsy
  • men who have sex with other men
  • curative intent of treatment
  • IMRT required
  • concurrent chemotherapy required

Exclusion Criteria

  • Patients who have undergone surgery for anal cancer
  • patients who can't read, write or are unable to answer to questionnaire

Outcomes

Primary Outcomes

Evaluate quality of life validated questionnaire (EORTC QLQ-30) among patients treated for anal cancer with concurrent chemoradiotherapy who are men who have sex with other men

Time Frame: 2015-2020

Evaluate quality of life validated questionnaire (SF-36) among patients treated for anal cancer with concurrent chemoradiotherapy who are men who have sex with other men

Time Frame: 2015-2020

Evaluate quality of sexual life validated questionnaire (IIEF) among patients treated for anal cancer with concurrent chemoradiotherapy who are men who have sex with other men

Time Frame: 2015-2020

Secondary Outcomes

  • Evaluate quality of sexual life with other questionnaires (SEAR) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (ISL) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (MSHQ-short version) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (CAYA-t) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (CSFQ-14) that are not validated in Portuguese language in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (SEX-Q) in the same population(2015-2020)
  • Evaluate quality of sexual life with other questionnaires (SHIM) in the same population(2015-2020)
  • Evaluate quality of life among patients who are HIV positive in this cohort with the use of questionnaire HAT-QoL(2015-2020)

Study Sites (1)

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