Quality of Life and Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) Lobectomy Versus Thoracotomy and Lobectomy - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00598000

Purpose

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.

Condition	Intervention
Lung Cancer Quality of Life Video-Assisted Thoracic Surgery (VATS) Thoracotomy	Behavioral: questionnaires

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Quality of Life and Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) Lobectomy Versus Thoracotomy and Lobectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Determine the postoperative change in QOL and level of pain in patients with clinical stage I NSCLC undergoing VATS lobectomy and for patients with clinical stage I NSCLC undergoing thoracotomy and lobectomy. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare early postoperative analgesic requirements between the VATS and thoracotomy groups. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	February 2005
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 for lobectomy 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

MSKCC Clinics

Criteria

Inclusion Criteria:

Patients with histologically confirmed or suspected clinical stage I non-small cell lung cancer based on standard staging (CT, PET, ± mediastinoscopy).
Patients with adequate cardiopulmonary reserve to tolerate lobectomy (FEV1 ≥ 40% predicted and DLCO ≥ 40% predicted, no unstable angina or reversible cardiac ischemia on stress test).
Patients offered a VATS lobectomy or a standard, posterolateral thoracotomy and lobectomy at MSKCC.
Patients cannot have had prior therapy, including surgery for the current lesion, systemic chemotherapy or external beam radiotherapy.
KPS ≥ 70.

Exclusion Criteria:

Patients who have already undergone the planned operation.
Patients who cannot tolerate lobectomy.
Patients with locally advanced or metastatic disease found either preoperatively or at the time of operation.
Patients who undergo surgical resection less than a lobectomy.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598000

Contacts

Contact: Bernard Park, MD		parkb@mskcc.org
Contact: Valeria Rusch, MD		ruschv@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Bernard Park, MD parkb@mskcc.org
Contact: Valeria Rusch, MD ruschv@mskcc.org
Principal Investigator: Bernard Park, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Bernard Park, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Bernard Park, MD )
Study ID Numbers:	05-006
Study First Received:	January 9, 2008
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00598000 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Lung cancer
Quality of Life
VATS
thoracotomy

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Quality of Life
Pain
Analgesics

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on September 11, 2009