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 Details
Study Description
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 | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Anal cancer proven biopsy
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men who have sex with other men
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curative intent of treatment
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IMRT required
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concurrent chemotherapy required
Exclusion Criteria:
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Patients who have undergone surgery for anal cancer
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patients who can't read, write or are unable to answer to questionnaire
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ICESP | Sao Paulo | Brazil | 01.246-903 |
Sponsors and Collaborators
- Instituto do Cancer do Estado de São Paulo
Investigators
- Principal Investigator: Geovanne Mauro, MD, physician
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 576/15