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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598000
• Other study ID #: 05-006
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: April 22, 2015
• Start date: February 2005
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Quality of Life
• Thoracotomy
• Video-assisted Thoracic Surgery (VATS)

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		conclusion of study	No
Secondary	Compare early postoperative analgesic requirements between the VATS and thoracotomy groups.		conclusion of study	No

External Links

•   Memorial Sloan Kettering Cancer Center