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

This study is currently recruiting participants.

Verified March 2012 by University of Alberta

Sponsor:

Collaborator:

Johnson & Johnson

Information provided by (Responsible Party):

University of Alberta

ClinicalTrials.gov Identifier:

NCT01555502

First received: March 7, 2012

Last updated: March 13, 2012

Last verified: March 2012

History of Changes

Purpose

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.

Condition
Operable Early Stage NSCLC by the VATS Approach

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:

Health related Quality of life [ Time Frame: Change in health related quality of life at 2 weeks. Change of Health Related Quality of Life at 4 weeks. Change in Health Related Quality of Life at 8 weeks. Change in Health Related Quality of Life at 12 weeks. ] [ Designated as safety issue: No ]
Health Related Quality of Life will be assessed using the SF-36, EQ-5D and QLQ30/13 questionnaires.

Estimated Enrollment:	50
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2012

Groups/Cohorts
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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with operable early stage NSCLC by the VATS approach who are referred to the Thoracic surgery Center in Edmonton, Alberta, Canada.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555502

Contacts

Contact: Sayf Gazala, MD

780 628 7485

gazala@ualberta.ca

Locations

Canada, Alberta
Royal Alexandra Hospital	Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Patricia Thompson, CCRP 780 735 4096 patrica.thompson@albertahealthservices.ca
Principal Investigator: Eric Bedard, MD, FRCSC

Sponsors and Collaborators

University of Alberta

Johnson & Johnson

More Information

No publications provided

Responsible Party:	University of Alberta
ClinicalTrials.gov Identifier:	NCT01555502 History of Changes
Other Study ID Numbers:	HRQOL VATS lobectomy
Study First Received:	March 7, 2012
Last Updated:	March 13, 2012
Health Authority:	Canada: University of Alberta

ClinicalTrials.gov processed this record on May 22, 2013

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