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NCT02949596 Clinical Trial

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

Quality of Life Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02949596
Other study ID # 576/15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2015
Est. completion date February 2021

Study information
Verified date February 2021
Source Instituto do Cancer do Estado de São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date February 2021
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Quality of life and quality of sexual life questionnaires

Locations
Country Name City State
Brazil ICESP Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

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