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OpenTrials
Completed

NCT Number: NCT01555502

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.

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Key information

Conditions

Operable Early Stage NSCLC by the VATS Approach

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Johnson & Johnson

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2012
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.