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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501319
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : November 8, 2011
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment
Lung Cancer Behavioral: Interactive Voice Response (IVR) Behavioral: Questionnaire

Detailed Description:

Before surgery, you will be asked to complete four surveys about your mood, symptoms, quality of life, and smoking history. Completing the questionnaires will take about 20 minutes. You will be asked for some information about age, sex, race, education, marital status, and employment status (full-time, part-time, unemployed). Before surgery, the research nurse will teach you how to use the special telephone system, called an Interactive Voice Response (IVR) telephone system. This system is used for tracking symptoms at home. An instruction pamphlet will also be given to you.

Three days after surgery, while you are in the hospital, you will be asked by the research nurse to again complete one questionnaires that measures your symptoms.

Once you are home from the hospital, the automatic telephone IVR system will call at a prescheduled time that is convenient for you. The phone call will take about four minutes to complete. The IVR will call once a week for the first 3 months after surgery, and then every two weeks for an additional 3 months.

The research nurse will call you one week after surgery and then one month, three months, and six months to complete four questionnaires about symptoms, mood, quality of life, and smoking history. It will take about 20 minutes to complete the questionnaires.

The information collected by the IVR is for research purposes only, and you must report any symptoms that you are concerned about to your physicians or nurses.

Should severe symptoms develop, research staff will notify the your treatment team.

This is an investigational study. About 112 patients will participate in this study. All will be enrolled at M. D. Anderson.

Study Type : Observational
Actual Enrollment : 127 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Longitudinal Measurement of Pain and Other Symptoms of Non-Small Cell Lung Cancer (NSCLC) Patients Following Thoracic Surgery
Study Start Date : April 2003
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with Non-Small Cell Lung Cancer.
Behavioral: Interactive Voice Response (IVR)
Phone calls once weekly for the first 3 months after surgery, then every two weeks for an additional 3 months.
Behavioral: Questionnaire
Questionnaires taking 20 minutes to complete.
Other Name: Survey

Primary Outcome Measures :
  1. To study the symptoms of patients who receive thoracic surgery for the treatment of lung cancer. [ Time Frame: 6 Years ]

Secondary Outcome Measures :
  1. To test the usefulness of a special telephone system for tracking the symptoms of patients after they have had thoracic surgery. [ Time Frame: 6 Years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Non-Small Cell Lung Cancer.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501319

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Principal Investigator: Xin Shelley Wang, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00501319     History of Changes
Other Study ID Numbers: ID02-320
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by M.D. Anderson Cancer Center:
Interactive Voice Response Telephone System
Non-Small Cell Lung Cancer
Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms