Lung CancerHOC-LCNCT02363101
Health Outcomes and Costs (HOC) in Lung Cancer (LC)
An observational study of Lung Cancer, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the costs, health-related quality of life and preference values from lung cancer patients assisted in a Brazilian public health care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients from Instituto Nacional de Câncer during one year.
Who may be able to join
- Clinical diagnosis of lung cancer disease
- Able to understand the overall concept of study and sign the written informed consent
Who cannot join
- Illiterate
- Visible cognitive impaired
- Non-primary lung tumor
Trial locations and contacts
1 site in 1 country.
Brazil1 site
INCA - Instituto Nacional de Câncer
Rio de Janeiro, Rio de Janeiro
Luciene Schluckebier, 55 21 32076660, lschluckebier@inca.gov.br
Alessandra Marins, 55 21 32076569, amarins@inca.gov.br
About this study
Official title: Health Outcomes and Costs (HOC) in Brazilian Public Health Care System - The HOC Study in Lung Cancer
The purpose of this study is to evaluate the costs, health-related quality of life and preference values from lung cancer patients assisted in a Brazilian public health care unit.
Read the detailed description
The costs will be assessed by micro-costing approach. All procedures involved in lung cancer at diagnosis, staging, treatment and best supportive care will be assessed.
The health-related quality of life will be assessed by EORTC-QLQ-C30, EQ-5D and EORTC-QLQ-LC13 in all different stages of lung cancer.
An utility measure will be considered. The preference values will be assessed via discrete choice experiment. Two scenarios will be designed and the lung cancer patients will be asked about the preferences.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct costs
Direct costs related to each procedure involved on lung cancer
Measured: one year
HRQoL
Measured: up to 30 days after the procedure
Preference values
Evaluate preference values in hypothetic scenarios
Measured: cross sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Collaborators
- Instituto Nacional de Cardiologia de Laranjeiras
- Responsible party
- Principal investigator, Carlos Gil Moreira Ferreira, Instituto Nacional de Cancer, Brazil
- Investigators
- Carlos Gil Ferreira, Principal investigator, National Cancer Institute, FranceLuciene Schluckebier, Study director, National Cancer Institute, FranceMarisa Santos, Study chair, INCBruna Carvalho, Study chair, National Cancer Institute, FrancePedro Masson, Study chair, National Cancer Institute, FranceAndréa Monteiro, Study chair, INCBruna Medeiros, Study chair, INCKátia Senna, Study chair, INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363101
- Sponsor's protocol ID
- INCA012015
- Acronym
- HOC-LC
- Status last verified
- Mar 2015
- First submitted
- 9 Feb 2015
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes and Costs (HOC) in Brazilian Public Health Care System - The HOC Study in Lung Cancer
- ClinicalTrials.gov ID
- NCT02363101
- Acronym / sponsor ID
- HOC-LC / INCA012015
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Collaborators
- Instituto Nacional de Cardiologia de Laranjeiras
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Feb 2015 (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.
The purpose of this study is to evaluate the costs, health-related quality of life and preference values from lung cancer patients assisted in a Brazilian public health care unit.
Detailed description
The costs will be assessed by micro-costing approach. All procedures involved in lung cancer at diagnosis, staging, treatment and best supportive care will be assessed.
The health-related quality of life will be assessed by EORTC-QLQ-C30, EQ-5D and EORTC-QLQ-LC13 in all different stages of lung cancer.
An utility measure will be considered. The preference values will be assessed via discrete choice experiment. Two scenarios will be designed and the lung cancer patients will be asked about the preferences.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients from Instituto Nacional de Câncer during one year.
Key inclusion criteria (2 listed)
- Clinical diagnosis of lung cancer disease
- Able to understand the overall concept of study and sign the written informed consent
Key exclusion criteria (3 listed)
- Illiterate
- Visible cognitive impaired
- Non-primary lung tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Direct costs
Time frame: one year
Direct costs related to each procedure involved on lung cancer
HRQoL
Time frame: up to 30 days after the procedure
Preference values
Time frame: cross sectional
Evaluate preference values in hypothetic scenarios
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
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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.
Carlos Gil Ferreira principal investigator
National Cancer Institute, France
Luciene Schluckebier study director
National Cancer Institute, France
Marisa Santos study chair
INC
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 Lung Cancer, run by Instituto Nacional de Cancer, Brazil 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Mar 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luciene Schluckebier (552132076660, lschluckebier@inca.gov.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct costs (time frame: one year). 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 4 Mar 2015.