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

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.

Study Overview

• Status: Completed
• Conditions: Operable Early Stage NSCLC by the VATS Approach

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5H 3V9
      • Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related Quality of life	Health Related Quality of Life will be assessed using the SF-36, EQ-5D and QLQ30/13 questionnaires.	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.

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Johnson & Johnson

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: HRQOL VATS lobectomy