Anal CancerNCT02949596
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
An observational study of Anal Cancer and Quality of Life, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Anal Cancer, Quality of Life
- What is being tested?
- Quality of life and quality of sexual life questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with anal cancer who are men who have sex with other men and are able to answer to questionnaires
Who may be able to join
- Anal cancer proven biopsy
- men who have sex with other men
- curative intent of treatment
- IMRT required
- concurrent chemotherapy required
Who cannot join
- Patients who have undergone surgery for anal cancer
- patients who can't read, write or are unable to answer to questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Quality of life and quality of sexual life questionnaires
- Keywords
- quality of sexual life, intensity-modulated radiotherapy, concurrent chemoradiotherapy
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life and quality of sexual life questionnairesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 2015-2020
Evaluate quality of sexual life with other questionnaires (ISL) in the same population
Measured: 2015-2020
Evaluate quality of sexual life with other questionnaires (MSHQ-short version) in the same population
Measured: 2015-2020
Evaluate quality of sexual life with other questionnaires (SEAR) in the same population
Measured: 2015-2020
Evaluate quality of sexual life with other questionnaires (SEX-Q) in the same population
Measured: 2015-2020
Evaluate quality of sexual life with other questionnaires (SHIM) in the same population
Measured: 2015-2020
Evaluate quality of sexual life with other questionnaires (CAYA-t) in the same population
Measured: 2015-2020
Evaluate quality of life among patients who are HIV positive in this cohort with the use of questionnaire HAT-QoL
Measured: 2015-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2020
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geovanne Pedro Mauro, Instituto do Cancer do Estado de São Paulo
- Investigators
- Geovanne Mauro, MD, Principal investigator, physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949596
- Sponsor's protocol ID
- 576/15
- Status last verified
- Feb 2021
- First submitted
- 25 Oct 2016
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02949596
- Acronym / sponsor ID
- 576/15
- Conditions
- Anal Cancer, Quality of Life
- Keywords
- quality of sexual life, intensity-modulated radiotherapy, concurrent chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with anal cancer who are men who have sex with other men and are able to answer to questionnaires
Key inclusion criteria (5 listed)
- Anal cancer proven biopsy
- men who have sex with other men
- curative intent of treatment
- IMRT required
- concurrent chemotherapy required
Key exclusion criteria (2 listed)
- Patients who have undergone surgery for anal cancer
- patients who can't read, write or are unable to answer to questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life and quality of sexual life questionnaires | Behavioural | – |
Primary outcome
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
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
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
8 secondary outcomes
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
Evaluate quality of sexual life with other questionnaires (ISL) in the same population
Time frame: 2015-2020
Evaluate quality of sexual life with other questionnaires (MSHQ-short version) in the same population
Time frame: 2015-2020
Evaluate quality of sexual life with other questionnaires (SEAR) in the same population
Time frame: 2015-2020
Evaluate quality of sexual life with other questionnaires (SEX-Q) in the same population
Time frame: 2015-2020
Evaluate quality of sexual life with other questionnaires (SHIM) in the same population
Time frame: 2015-2020
Evaluate quality of sexual life with other questionnaires (CAYA-t) in the same population
Time frame: 2015-2020
Evaluate quality of life among patients who are HIV positive in this cohort with the use of questionnaire HAT-QoL
Time frame: 2015-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geovanne Mauro, MD principal investigator
physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer and Quality of Life, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2015-2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.