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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Anal Cancer
• Intervention / Treatment: Behavioral: Quality of life and quality of sexual life questionnaires

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 Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01.246-903
    • ICESP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with anal cancer who are men who have sex with other men and are able to answer to questionnaires

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 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 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

Outcome Measure	Time Frame
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 (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 (SEAR) 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 sexual life with other questionnaires (CAYA-t) 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

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Principal Investigator: Geovanne Mauro, MD, Physician

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: concurrent chemoradiotherapy; intensity-modulated radiotherapy; quality of sexual life
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Anus Neoplasms
• Other Study ID Numbers: 576/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO