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

Operable Early Stage NSCLC by the VATS Approach Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555502
• Other study ID #: HRQOL VATS lobectomy
• Status: Completed
• Phase: N/A
• First received: March 7, 2012
• Last updated: May 26, 2015
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2015
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: University of Alberta
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Operable Early Stage NSCLC by the VATS Approach

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Johnson & Johnson

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No