Health Outcomes and Costs (HOC) in Lung Cancer (LC)

Lung Cancer Clinical Trial

— HOC-LC  

Official title:

Health Outcomes and Costs (HOC) in Brazilian Public Health Care System - The HOC Study in Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02363101
• Other study ID #: INCA012015
• Status: Not yet recruiting
• Phase: N/A
• First received: February 9, 2015
• Last updated: March 3, 2015
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Instituto Nacional de Cancer, Brazil
• Contact: Luciene Schluckebier
• Phone: 552132076660
• Email: lschluckebier[@]inca.gov.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of lung cancer disease

• Able to understand the overall concept of study and sign the written informed consent

Exclusion Criteria:

• Illiterate

• Visible cognitive impaired

• Non-primary lung tumor

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Brazil	INCA - Instituto Nacional de Câncer	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Cancer, Brazil	Instituto Nacional de Cardiologia de Laranjeiras

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct costs	Direct costs related to each procedure involved on lung cancer	one year	No
Primary	HRQoL		up to 30 days after the procedure	No
Primary	Preference values	Evaluate preference values in hypothetic scenarios	cross sectional	No