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

NCT00598000 | Completed

• 1 other identifier: 05-006
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Lung cancer; Quality of Life; VATS; thoracotomy; 05-006

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare early postoperative analgesic requirements between the VATS and thoracotomy groups.

  conclusion of study

Study Arms (2)

1

Determine the impact, in terms of quality of life (QOL), of minimally invasive, video-assisted thoracic surgery (VATS)

Behavioral: questionnaires

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

Interventions

questionnaires BEHAVIORAL

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSKCC Clinics

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nabil Rizk, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: February 1, 2005
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 23, 2015

Record last verified: 2015-04

Locations

US (1)