Quality of Life and Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) Anatomic Lung Resection Versus Thoracotomy and Anatomic Lung Resection

April 22, 2015 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to see if different types of surgery for lung cancer have different effects on quality of life and pain. What we learn from this study may help us find new ways to improve the quality of life of lung cancer patients who have surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

MSKCC Clinics

Description

Inclusion Criteria:

  • Patients with histologically confirmed or suspected clinical stage I non small cell lung cancer (including carcinoid tumors) based on standard staging (CT, PET, ± mediastinoscopy).
  • Patients offered a VATS anatomic lung resection or a standard, posterolateral thoracotomy and anatomic lung resection at MSKCC.
  • Patients cannot have had prior therapy, including surgery for the current lesion, systemic chemotherapy or external beam radiotherapy.
  • KPS ≥ 70.
  • Synchronous primaries within one lobe.

Exclusion Criteria:

  • Patients who have already undergone the planned operation.
  • Patients who cannot tolerate segmentectomy or lobectomy.
  • Patients with locally advanced or metastatic disease found either preoperatively or at the time of operation.
  • Patients who are non- English speaking
  • Patients with multi-focal disease
  • Patients with con-current cancers
  • Patients with benign disease.
  • Patients who are unwilling or unable to return to Memorial Sloan-Kettering Cancer Center for postoperative follow-up for the first year following their operation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Determine the impact, in terms of quality of life (QOL), of minimally invasive, video-assisted thoracic surgery (VATS)
Behavioral: questionnaires

QOL Measures- The following measures will be administered at Pre-Op, First Post-Op Visit 4, 8, 12 months Post-Op.

Brief Pain Inventory and daily analgesic log- enrollment, patients will fill out the BPI preoperatively, postoperative days 2 to 4, initial, 4-month, 8-month and 12-month postoperative visits.
2
Determine the impact, in terms of quality of life (QOL), in traditional thoracotomy and anatomic lung resection in early stage lung cancer.
Behavioral: questionnaires

QOL Measures- The following measures will be administered at Pre-Op, First Post-Op Visit 4, 8, 12 months Post-Op.

Brief Pain Inventory and daily analgesic log- enrollment, patients will fill out the BPI preoperatively, postoperative days 2 to 4, initial, 4-month, 8-month and 12-month postoperative visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the postoperative change in QOL and level of pain in patients with clinical stage I NSCLC undergoing VATS anatomic lung resection and for patients with clinical stage I NSCLC undergoing thoracotomy and anatomic lung resection
Time Frame: conclusion of study
conclusion of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare early postoperative analgesic requirements between the VATS and thoracotomy groups.
Time Frame: conclusion of study
conclusion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Nabil Rizk, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 18, 2008

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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