Using an Interactive Voice Response Telephone System in the Assessment and Management of Symptoms in Advanced Lung Cancer Patients Receiving Chemotherapy
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 from 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Ratio of Number of Alerts Generated by Symptom Distress Over the Number of Available Assessments
Total number of alerts generated by symptom exceeding prespecified threshold for 7 symptoms - pain, fatigue, nausea, cough, constipation, vomiting and shortness of breath (Ratio alerts/number of assessments using IVR telephone triage/feedback versus IVR only). Reporting 0-10 severity scale of MD Anderson Symptom Inventory from 0 (symptom not present) to 10 (symptom bad as imagine it could be). Thresholds set at 4 on scale for all symptoms except shortness of breath and constipation where threshold set at 2. More than one symptom alert may appear per assessment causing ratio values to exceed 1.
Baseline to end of first chemotherapy cycle (generally chemotherapy and 1 assessment of response within 6-8 weeks)
Charles Cleeland, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|