IVR Symptom Assessment in Non-Small Cell Lung Cancer (NSCLC) Patients

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IVR Symptom Assessment in Non-Small Cell Lung Cancer (NSCLC) Patients
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
Sponsored by: M.D. Anderson Cancer Center

Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00423436

Purpose
Primary Objectives:

To compare the effectiveness of an interactive voice response (IVR) telephone triage/feedback system versus an interactive voice response telephone system with assessment only in monitoring and managing symptoms in patients with advanced non small cell lung cancer (NSCLC).
To compare differences in mood and quality of life variables of patients using the IVR triage/feedback system versus IVR assessment only.
To compare the healthcare utilization (emergency visits, admissions, length of stay for hospitalizations for uncontrolled symptoms) of patients using the IVR triage/feedback system versus IVR assessment only.


Condition Intervention
Lung Cancer
Behavioral: Questionnaire
Behavioral: Interactive Voice Response Telephone System




MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Using an Interactive Voice Response Telephone System in the Assessment and Management of Symptoms in Advanced Lung Cancer Patients Receiving Chemotherapy


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


Primary Outcome Measures:
To see if there is a better way to manage symptoms that patients who are receiving chemotherapy for lung cancer may experience. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]



Secondary Outcome Measures:
To test the usefulness of a special telephone system for monitoring the symptoms of patients receiving chemotherapy. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]


Estimated Enrollment: 136
Study Start Date: April 2003
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
IVR Assessment Plus Triage Behavioral: Questionnaire
Questionnaires taking about 30-45 minutes to complete.
Behavioral: Interactive Voice Response Telephone System
Arm 1 = Patients will report symptoms to the telephone system and the doctor or nurse will be notified when a symptom is severe; Arm 2 = Phone calls twice weekly, each call lasting less than 5 minutes.
2: Experimental
IVR Assessment Only Behavioral: Questionnaire
Questionnaires taking about 30-45 minutes to complete.
Behavioral: Interactive Voice Response Telephone System
Arm 1 = Patients will report symptoms to the telephone system and the doctor or nurse will be notified when a symptom is severe; Arm 2 = Phone calls twice weekly, each call lasting less than 5 minutes.


Detailed Description:
You will be asked to complete several questionnaires during a visit to the Thoracic Clinic. These questionnaires measure physical and emotional symptoms, and quality of life. Completing the questionnaires takes about 30-45 minutes. The research nurse will also teach you how to use the telephone system for reporting symptoms. You will tell the research nurse when the most convenient times for the telephone calls and the telephone system will be set up to call at those times.

It is not clear at this time whether the telephone symptom evaluation is better than the usual plan that doctors and nurses follow for asking about symptoms. For this reason, you will be randomly picked (as in the toss of a coin) to be in one of two groups. The chance of being in either one of the two programs is about equal.

Half of the patients will be assigned to the "telephone assessment system plus triage" group. If you are assigned to this group, you will report symptoms to the telephone system and the doctor or nurse at M.D. Anderson will be notified when a symptom is severe. You will also be encouraged to report all symptoms to their doctor and nurse at M.D. Anderson.

Half of the patients will be assigned to the "telephone assessment only" group. If you are assigned to this group, your symptom information will only be given through the telephone system. You will also be encouraged to report all symptoms directly to your doctor and nurse at M.D. Anderson. Your physician may request information form the telephone system.

If you are assigned to this "telephone assessment only" group, the telephone system will call you twice a week during 2 cycles of chemotherapy. It is programmed to ask you to rate your symptoms and how much the symptoms interfere in your life. Rating symptoms using the telephone system takes less than five minutes for each call.

After each chemotherapy cycle, you and patients in both groups will be asked to fill out questionnaires during a clinic visit. The questionnaires are used to measure emotional symptoms and quality of life. Completing the questionnaires takes about 15-30 minutes. Your medical charts will also be reviewed and information collected about medical history.

If you have agreed to participate in the companion caregiver study, the study staff will use your demographic and clinical data to study the influence of your symptoms on your caregiver's physical and mental health.

This is an investigational study. About 100 will be enrolled at M.D. Anderson Cancer Center. A total of 136 patients will take part in this multicenter study.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:

Patients diagnosed with stage III or IV NSCLC or SCLC (Patients who have received other prior chemotherapy are eligible.)
18 years of age or older
English-speaking
Lives in the United States
Adequate vision and hearing to use the IVR system
Provides written informed consent
Exclusion Criteria:

Current diagnosis of psychosis or dementia
Patients unable to complete the assessment measures or unable to understand the purpose of the study
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423436


Contacts
Contact: Charles Cleeland, PhD 713-745-3470


Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Charles Cleeland, PhD

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Charles Cleeland, PhD U.T.M.D. Anderson Cancer Center

More Information


MD Anderson Cancer Center

Responsible Party: U.T.M.D. Anderson Cancer Center ( Charles Cleeland, PhD/Professor )
Study ID Numbers: ID01-243
Study First Received: January 16, 2007
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00423436 [history]
Health Authority: United States: Institutional Review Board

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



Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type



ClinicalTrials.gov processed this record on February 10, 2009


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