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

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Brief 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

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

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 Type

Observational


Primary Outcome

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

Secondary Outcome

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

Condition

Anal Cancer

Intervention

Quality of life and quality of sexual life questionnaires


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

19

Start Date

October 2015

Completion Date

February 2021

Primary Completion Date

October 2020

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
      

Gender

Male

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Geovanne Mauro, MD, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT02949596

Organization ID

576/15


Responsible Party

Principal Investigator

Study Sponsor

Instituto do Cancer do Estado de São Paulo


Study Sponsor

Geovanne Mauro, MD, Principal Investigator, physician


Verification Date

February 2021