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Clinical Trials/NCT01555502
NCT01555502
Completed
Not Applicable

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

University of Alberta1 site in 1 country50 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Operable Early Stage NSCLC by the VATS Approach
Sponsor
University of Alberta
Enrollment
50
Locations
1
Primary Endpoint
Health related Quality of life
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
March 2012
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.

Health Related Quality of Life will be assessed using the SF-36, EQ-5D and QLQ30/13 questionnaires.

Study Sites (1)

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