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
1 other identifier
observational
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedFebruary 9, 2021
February 1, 2021
5 years
October 25, 2016
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
Patients diagnosed with anal cancer who are men who have sex with other men and are able to answer to questionnaires
You may qualify if:
- Anal cancer proven biopsy
- men who have sex with other men
- curative intent of treatment
- IMRT required
- concurrent chemotherapy required
You may not qualify if:
- Patients who have undergone surgery for anal cancer
- patients who can't read, write or are unable to answer to questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICESP
São Paulo, 01.246-903, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geovanne Mauro, MD
physician
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 25, 2016
First Posted
October 31, 2016
Study Start
October 1, 2015
Primary Completion
October 1, 2020
Study Completion
February 1, 2021
Last Updated
February 9, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share