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Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00422500
First received: January 12, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Primary Objectives:

  • To compare the severity of symptoms, their impact on affective and health-related functional status, and symptom interference among patients with advanced-stage lung cancer following initiation of chemotherapy by disease status, tumor response to chemotherapy, and adequacy of symptom management.
  • To examine the relationship of disease-related and treatment-related physical symptoms to affective impairment and the patient's reported symptom interference and functional impairment.
  • To compare symptom severity, adequacy of symptom management, and interference with affective status and health-related function by patient's minority status.
  • To explore the serum level of inflammatory cytokines during chemotherapy among lung cancer patients.
  • To measure DNA repair capacity (DRC) in lymphocyte cultures of all patients enrolled in the protocol at baseline (before treatment) and during each follow-up blood draw. The hypothesis is that patients with suboptimal DRC will do better with chemotherapy than patients with efficient DRC.
  • To extract DNA and genotype for polymorphisms in genes involved in the nucleotide excision repair pathway and in those involved in response to pain (opioid receptors, dopamine receptors, COMT). We hypothesize that:

    1. Polymorphisms in NER genes that modulate DNA repair capacity will also effect response to chemotherapy and to outcome.
    2. Cytokine gene polymorphisms account for variations in symptom outcomes (specific symptoms and symptom clusters) before, during and after chemotherapy.
    3. The COMT val/met polymorphism affects the metabolism of catecholamines on the modulation of response to sustained pain.
    4. Dopamine receptor polymorphisms that result in decreased density of dopamine receptors will result in a deficit in the dopamine pathway. that will also affect response to pain.
  • To evaluate neurocognitive function to determine the prevalence, severity, and pattern of cognitive symptoms.

Condition Intervention
Lung Cancer
Behavioral: Questionnaire
Behavioral: Telephone Interactive System
Other: Blood Samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of the Prevalence, Severity, and Interference of Multiple Symptoms in Advanced Lung Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Longitudinal Data on Symptom Patterns + Severity [ Time Frame: Total weekly IVR assessment period 18 weeks, generally include 6 cycles of chemotherapy and 2-3 assessments of response to chemotherapy. ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Study participants enrolled at M. D. Anderson will have additional serum drawn for cytokine analysis and DNA repair capacity. This blood will be drawn at the routine blood draws before treatment begins, and at the beginning of each treatment cycle.


Enrollment: 204
Study Start Date: November 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chemotherapy Symptoms
Study participants with advanced-stage lung cancer.
Behavioral: Questionnaire
Surveys about symptoms, mood, and quality of life.
Behavioral: Telephone Interactive System
Automated telephone system call once a week during therapy, rating of severity of symptoms and daily life interference done with numeric key pad. Post therapy is complete, a call every two weeks for up to six months.
Other Name: IVR Telephone System
Other: Blood Samples
For participating patients, 3 additional tablespoons of blood drawn at the beginning of each chemotherapy treatment (before treatment starts) and at the beginning of each cycle of treatment.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study participants with advanced-stage lung cancer and disease- or treatment-related symptoms.

Criteria

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
  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: NCT00422500

Locations
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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: NCT00422500     History of Changes
Other Study ID Numbers: 2003-0701
Study First Received: January 12, 2007
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014