Health Outcomes and Costs (HOC) in Lung Cancer (LC) | NCT02363101

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

NCT02363101

Sponsor

Instituto Nacional de Cancer, Brazil

Status

Unknown status

Last Update Posted

Mar 4, 2015Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Feb 9, 2015

First Submission Date that Met QC Criteria

Feb 9, 2015

First Posted Date

Feb 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2015

Last Update Posted Date

Mar 4, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlos Gil Moreira Ferreira, MD PHD, Instituto Nacional de Cancer, BrazilPrincipal Investigator

Lead Sponsor

Instituto Nacional de Cancer, BrazilOTHER_GOV

Collaborators

Name	Class
Instituto Nacional de Cardiologia de Laranjeiras	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Direct costs	Direct costs related to each procedure involved on lung cancer	one year
HRQoL		up to 30 days after the procedure
Preference values	Evaluate preference values in hypothetic scenarios	cross sectional

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Lung cancer patients from Instituto Nacional de Câncer during one year.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luciene Schluckebier	Contact	552132076660		lschluckebier@inca.gov.br
Alessandra Marins	Contact	55 21 32076569		amarins@inca.gov.br

Overall Officials

Name	Affiliation	Role
Carlos Gil Ferreira	National Cancer Institute, France	Principal Investigator
Luciene Schluckebier	National Cancer Institute, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INCA - Instituto Nacional de Câncer		Rio de Janeiro	Rio de Janeiro		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided