Clinical trial 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Cancer
Quality of Life
Keywords: quality of sexual life
intensity-modulated radiotherapy
concurrent chemoradiotherapy
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 19
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: 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
timeFrame: 2015-2020
measure: 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
timeFrame: 2015-2020
measure: 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
timeFrame: 2015-2020
Secondary outcomes:
measure: Evaluate quality of sexual life with other questionnaires (CSFQ-14) that are not validated in Portuguese language in the same population
timeFrame: 2015-2020
measure: Evaluate quality of sexual life with other questionnaires (ISL) in the same population
timeFrame: 2015-2020
measure: Evaluate quality of sexual life with other questionnaires (MSHQ-short version) in the same population
timeFrame: 2015-2020
measure: Evaluate quality of sexual life with other questionnaires (SEAR) in the same population
timeFrame: 2015-2020
measure: Evaluate quality of sexual life with other questionnaires (SEX-Q) in the same population
timeFrame: 2015-2020
measure: Evaluate quality of sexual life with other questionnaires (SHIM) in the same population
timeFrame: 2015-2020
measure: Evaluate quality of sexual life with other questionnaires (CAYA-t) in the same population
timeFrame: 2015-2020
measure: Evaluate quality of life among patients who are HIV positive in this cohort with the use of questionnaire HAT-QoL
timeFrame: 2015-2020
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: ICESP
Study officials:
affiliation: physician
name: Geovanne Mauro, MD
role: PRINCIPAL_INVESTIGATOR
References: