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

Completed

• Conditions: Anal Cancer; Quality of Life

• Registration Number: NCT02949596
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-10-31
• Primary Completion: 2020-10
• Status Verified: 2021-02
• Study Completion: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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
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 Outcome Measures

Name	Time	Method
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 (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 (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

Trial Locations

Locations (1)

ICESP; 🇧🇷 Sao Paulo, Brazil