Measurement of Pain and Other Symptoms of Non-Small Cell Lung Cancer (NSCLC) Patients Following Thoracic Surgery

NCT00501319 | Completed

• 1 other identifier: ID02-320
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• To longitudinally assess the natural history of symptoms (prevalence, severity, patterns of symptoms, and the relationship of physical and psychological distress) among post-thoracic surgery for non-small cell lung cancer patients with early stage (stage I-IIIA) disease.
• To determine crisis events (when symptoms are most severe), their relationship with cancer therapy, surgical techniques and disease, and their relationship with function and quality of life; and to determine current practice patterns of symptom control throughout the six months of the post-surgical phase.
• To determine the utility of a weekly, telephone-administered interactive voice response symptom assessment (IVR-MDASI) for identifying emergent clinically significant symptoms in this population.
• To develop symptom severity critical values and critical treatment algorithms for post-operative symptom control for NSCLC patients.

Conditions

Lung Cancer

Keywords

Interactive Voice Response Telephone System; Non-Small Cell Lung Cancer; Lung Cancer; Questionnaire; Survey; NSCLC; IVR

Outcome Measures

Primary Outcomes (1)

• To study the symptoms of patients who receive thoracic surgery for the treatment of lung cancer.

  6 Years

Secondary Outcomes (1)

• To test the usefulness of a special telephone system for tracking the symptoms of patients after they have had thoracic surgery.

  6 Years

Study Arms (1)

1

Patients with Non-Small Cell Lung Cancer.

Behavioral: Interactive Voice Response (IVR); Behavioral: Questionnaire

Interventions

Interactive Voice Response (IVR) BEHAVIORAL

Phone calls once weekly for the first 3 months after surgery, then every two weeks for an additional 3 months.

1

Questionnaire BEHAVIORAL

Questionnaires taking 20 minutes to complete.

Also known as: Survey

1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Non-Small Cell Lung Cancer.

You may qualify if:

• Patients scheduled for thoracic surgery for NSCLC (stage I-IIIA)
• Patients \>/= 16 years of age
• Patients who speak English
• Patients residing in the United States

You may not qualify if:

• Current diagnosis of psychosis or dementia
• Patients who have difficulty understanding the intent of the study
• Patients who can not complete the assessment tools
• Patients without telephone access

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

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

• Xin Shelley Wang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 16, 2007
• Study Start: April 1, 2003
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

US (1)