Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00598000
First received: January 9, 2008
Last updated: May 14, 2014
Last verified: May 2014
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life and Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) Anatomic Lung Resection Versus Thoracotomy and Anatomic Lung Resection

Resource links provided by NLM:


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 anatomic lung resection and for patients with clinical stage I NSCLC undergoing thoracotomy and anatomic lung resection [ 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 ]

Enrollment: 216
Study Start Date: February 2005
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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 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.


  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 (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.
  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: NCT00598000

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Nabil Rizk, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00598000     History of Changes
Other Study ID Numbers: 05-006
Study First Received: January 9, 2008
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Lung cancer
Quality of Life
VATS
thoracotomy
05-006

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014