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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

March 7, 2012
March 13, 2012
March 2011
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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.
Same as current
Complete list of historical versions of study NCT01555502 on ClinicalTrials.gov Archive Site
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Health Related Quality of Life After Video Assisted Thoracoscopic Lobectomy for Lung Cancer
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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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with operable early stage NSCLC by the VATS approach who are referred to the Thoracic surgery Center in Edmonton, Alberta, Canada.
Operable Early Stage NSCLC by the VATS Approach
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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.
  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2012
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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
Both
18 Years and older
No
Contact: Sayf Gazala, MD 780 628 7485 gazala@ualberta.ca
Canada
 
NCT01555502
HRQOL VATS lobectomy
Yes
University of Alberta
University of Alberta
Johnson & Johnson
Not Provided
University of Alberta
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP