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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00598000

Collaborator

(none)

216

Enrollment

Location

121.9

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Quality of Life Video-assisted Thoracic Surgery (VATS) Thoracotomy	Behavioral: questionnaires Behavioral: questionnaires

Study Design

Study Type:

Observational

Actual Enrollment :

216 participants

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

Study Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	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.

Arm

Intervention/Treatment

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.

Determine the impact, in terms of quality of life (QOL), in traditional thoracotomy and anatomic lung resection in early stage lung cancer.

Behavioral: questionnaires

Outcome Measures

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 [conclusion of study]

Secondary Outcome Measures

Compare early postoperative analgesic requirements between the VATS and thoracotomy groups. [conclusion of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.