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Completed

NCT Number: NCT00501319

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

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.

Completed

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Questionnaire

Behavioral

Questionnaires taking 20 minutes to complete.

Other names: Survey

Primary outcomes

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

    Time frame: 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.

    Time frame: 6 Years

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Jul 16, 2007
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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