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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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ClinicalTrials.gov Identifier: NCT02949596
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Geovanne Pedro Mauro, 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.

Condition or disease Intervention/treatment
Anal Cancer Quality of Life 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949596


Contacts
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Contact: Geovanne Mauro, MD geovanne95@gmail.com
Contact: Karina Moutinho, MD karina.moutinho@hc.fm.usp.br

Locations
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Brazil
ICESP Recruiting
Sao Paulo, Brazil, 01.246-903
Contact: Geovanne Mauro, MD       geovanne95@gmail.com   
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
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Principal Investigator: Geovanne Mauro, MD physician

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Responsible Party: Geovanne Pedro Mauro, MD, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT02949596     History of Changes
Other Study ID Numbers: 576/15
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Geovanne Pedro Mauro, Instituto do Cancer do Estado de São Paulo:
quality of sexual life
intensity-modulated radiotherapy
concurrent chemoradiotherapy

Additional relevant MeSH terms:
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Anus Diseases
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases