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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Alberta.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014