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

NCT ID: NCT02949596

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2021-02-28

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.

Conditions

Anal Cancer; Quality of Life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Quality of life and quality of sexual life questionnaires

Intervention Type: BEHAVIORAL

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Geovanne Pedro Mauro

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geovanne Mauro, MD

Role: PRINCIPAL_INVESTIGATOR

physician

Locations

ICESP

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

576/15

Identifier Type: -

Identifier Source: org_study_id