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Completed

NCT Number: NCT02949596

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.

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Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Quality of Life Rectal Diseases Rectal Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

ICESP

São Paulo, 01.246-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of life and quality of sexual life questionnaires

Behavioral

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Evaluate quality of sexual life with other questionnaires (CSFQ-14) that are not validated in Portuguese language in the same population

    Time frame: 2015-2020

  2. Evaluate quality of sexual life with other questionnaires (ISL) in the same population

    Time frame: 2015-2020

  3. Evaluate quality of sexual life with other questionnaires (MSHQ-short version) in the same population

    Time frame: 2015-2020

  4. Evaluate quality of sexual life with other questionnaires (SEAR) in the same population

    Time frame: 2015-2020

  5. Evaluate quality of sexual life with other questionnaires (SEX-Q) in the same population

    Time frame: 2015-2020

  6. Evaluate quality of sexual life with other questionnaires (SHIM) in the same population

    Time frame: 2015-2020

  7. Evaluate quality of sexual life with other questionnaires (CAYA-t) in the same population

    Time frame: 2015-2020

  8. Evaluate quality of life among patients who are HIV positive in this cohort with the use of questionnaire HAT-QoL

    Time frame: 2015-2020

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Oct 31, 2016
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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