Health Related Quality of Life After Video Assisted Thoracoscopic Lobectomy for Lung Cancer

NCT ID: NCT01555502

Last Updated: 2015-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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To test the effect of post operative complications on the health related quality of life (HRQOL) after Video Assisted Thoracoscopic Surgery (VATS) for Non-Small Cell Lung Cancer (NSCLC).

The HRQOL of patients with early stage NSCLC will be assessed at baseline (before surgery) using 3 different reliable and valid HRQOL questionnaire (SF-36, EQ-5D and QLQ30/13), then at regular intervals in the early post-operative period (2,4,8 and 12 weeks) the HRQOL will be assessed using the same questionnaires to determine the difference between patients with low/no post operative complications to those with high grade post-operative complications.

Post operative complications will be assess while the patients in the hospital on a daily basis using the Clavien classification system for surgical complications.

Detailed Description

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Conditions

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Operable Early Stage NSCLC by the VATS Approach

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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low complications

Patients who had VATS lung resection for NSCLC, and have no or low grade (grade 1 and 2) post operative complications based on the Clavien classification system.

No interventions assigned to this group

High complications

Patients who had VATS lung resection for NSCLC, and have no or high grade (grade 3 and 4) post operative complications based on the Clavien classification system.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adults (more than 18 years)
* early stage NSCLC
* speak English
* No hearing/Speaking difficulties
* Able to walk without assistance
* Surgery via the VATS approach

Exclusion Criteria

* Less than 18 years old
* Metastatic disease to the lung
* Benign Lung disease
* Advanced NSCLC
* Small Cell Lung Cancer
* Non English speakers
* Walking/Hearing/Speaking difficulties
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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HRQOL VATS lobectomy

Identifier Type: -

Identifier Source: org_study_id

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