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

This study has been completed.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00501319
First received: July 12, 2007
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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 Intervention
Lung Cancer
Behavioral: Interactive Voice Response (IVR)
Behavioral: Questionnaire

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To study the symptoms of patients who receive thoracic surgery for the treatment of lung cancer. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: April 2003
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Non-Small Cell Lung Cancer.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501319

Locations
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.
Investigators
Principal Investigator: Xin Shelley Wang, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501319     History of Changes
Other Study ID Numbers: ID02-320
Study First Received: July 12, 2007
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 16, 2014