Measurement of Pain and Other Symptoms of Non-Small Cell Lung Cancer (NSCLC) Patients Following Thoracic Surgery
NCT ID: NCT00501319
Last Updated: 2011-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
127 participants
OBSERVATIONAL
2003-04-30
2011-10-31
Brief Summary
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* 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.
Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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1
Patients with Non-Small Cell Lung Cancer.
Interactive Voice Response (IVR)
Phone calls once weekly for the first 3 months after surgery, then every two weeks for an additional 3 months.
Questionnaire
Questionnaires taking 20 minutes to complete.
Interventions
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Interactive Voice Response (IVR)
Phone calls once weekly for the first 3 months after surgery, then every two weeks for an additional 3 months.
Questionnaire
Questionnaires taking 20 minutes to complete.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients \>/= 16 years of age
* Patients who speak English
* Patients residing in the United States
Exclusion Criteria
* Patients who have difficulty understanding the intent of the study
* Patients who can not complete the assessment tools
* Patients without telephone access
16 Years
ALL
No
Sponsors
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American Cancer Society, Inc.
OTHER
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Xin Shelley Wang, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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ID02-320
Identifier Type: -
Identifier Source: org_study_id