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Longitudinal Study of the Prevalence, Severity, and Interference of Multiple Symptoms in Advanced Lung Cancer

18 Years
Not Enrolling
Lung Cancer

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Trial Information

Longitudinal Study of the Prevalence, Severity, and Interference of Multiple Symptoms in Advanced Lung Cancer

One of the ways to learn about the symptoms of chemotherapy is by looking at how certain
proteins called cytokines (found in the blood) change during therapy. Another way is to
look at how symptoms change during treatment.

Before therapy starts, you will be asked to complete several questionnaires during a visit
to the thoracic clinic at M. D. Anderson. These questionnaires measure physical and
emotional (mental) symptoms. The questionnaires should take about 60 minutes to finish.
You will also be asked to complete some cognitive (mental) questionnaires that take about
25 minutes to complete. During this visit, the research nurse will teach you how to use an
interactive voice response telephone system for measuring symptoms. The research nurse will
ask you the most convenient time for the telephone calls, and make sure the system is
programmed to call you at that time. The date of the call will be at the same or close to
the date of your weekly clinic visit.

Symptoms will be monitored weekly during chemotherapy treatment using this interactive voice
response telephone system. The automated telephone system will call you once a week, and
using the numeric key pad on your telephone, you will rate the severity of your symptoms and
how much they interfere in your daily life. Once you complete therapy, the phone system
will call every two weeks for up to six months. The information collected by these calls is
only being used for this research study.

In addition to the telephone calls, the research nurse will arrange to meet you
approximately every 6 weeks at your clinic visit. She will ask you to complete some surveys
about your symptoms, mood, and quality of life. This meeting will take about 45 minutes.
You will also be asked again to complete some cognitive (mental) questionnaires that take
about 25 minutes to complete.

Research staff will also obtain from your medical record clinical information and lab values
during your treatment period.

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.

You are encouraged to report your symptoms to your treating physicians during the study,
especially if you have any symptom that you rate greater than 7 on the 0 to 10 scale.

This is an investigational study. A total of up to 224 patients will take part in this
multicenter study. Up to 112 will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Is an adult > 18 years of age

2. Is diagnosed with Stage III or IV Lung cancer

3. Is scheduled for a new chemotherapy regimen. Patients who have received prior
chemotherapy are eligible.

4. Is English- or Spanish-speaking

5. Currently lives in the United States

Exclusion Criteria:

1. Does not have access to telephones

2. Is unable to use the telephone interactive system

3. Has a current diagnosis of psychosis or dementia

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Longitudinal Data on Symptom Patterns + Severity

Outcome Description:

IVR telephone system to collect longitudinal data on symptom patterns and severity using patient tumor response evaluation after 2-3 cycles chemotherapy and total weekly IVR assessment period at 18 weeks.

Outcome Time Frame:

Total weekly IVR assessment period 18 weeks, generally include 6 cycles of chemotherapy and 2-3 assessments of response to chemotherapy.

Safety Issue:


Principal Investigator

Xin Shelley Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2003

Completion Date:

December 2010

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Advanced Lung Cancer
  • Chemotherapy Symptoms
  • Disease-Related Symptoms
  • Treatment-Related Symptoms
  • Symptom Management
  • Questionnaire
  • Telephone Interactive System
  • IVR Telephone System
  • DNA Repair Capacity
  • DRC
  • Cognitive Symptoms
  • Lung Neoplasms



Jackson Memorial HospitalMiami, Florida  33136
Ben Taub General HospitalHouston, Texas  77030
UT MD Anderson Cancer CenterHouston, Texas  77030
Lyndon Baines Johnson General HospitalHouston, Texas  77030