This trial is active, not recruiting.

Condition lung cancer
Treatment questionnaire
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date June 2006
End date June 2016
Trial size 320 participants
Trial identifier NCT00504374, 2006-0273, CA109043


Primary Objectives:

- Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up.

- Develop preliminary statistical models incorporating genetic data (which will be obtained from an existing protocol, CPN 91-001, Margaret Spitz), disease-related variables (e.g., stage of disease, location of tumor), clinical health status (e.g., performance status, comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race) for predicting the risk of severe and persistent symptoms.

Analytical aim: To determine if symptoms (e.g., fatigue, depression, lack of appetite) will differ in severity by IL-6 gene polymorphisms (-174G/C, -597G/A, -572G/C, -373An/Tn).

This study (NIH-CA109043, Reyes-Gibby, 2004-2009) builds upon an NIH-funded (NIH-CA55769, Spitz, 2003-2008) study of the molecular epidemiology of lung cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients with lung cancer.
questionnaire Survey
Symptoms questionnaire lasting about 5 to 10 minutes.

Primary Outcomes

Patient Symptom Severity (MD Anderson Symptom Inventory Questionnaire)
time frame: Baseline (before), during (every week for 6 weeks), and after chemoradiation therapy (at 6-12 week intervals)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has lung cancer and is being treated at M. D. Anderson. - At least 18 years of age - Currently living in the United States - Enrolled in CPN 91-001 (Molecular epidemiology of lung cancer) - English or Spanish speaking Exclusion Criteria: - Patient is unable to understand the intent of the study.

Additional Information

Official title Gene Polymorphisms and Symptoms in Lung Cancer Patients
Principal investigator Cielito C. Reyes-Gibby, DrPH
Description If you agree to take part in this study, upon being admitted for treatment, you will be asked about your symptoms (how severe they are and to what degree they affect your day-to-day functioning). You will be asked to fill out a symptoms questionnaire each time you are at the clinic for your treatment and for your follow-up visits. The questionnaire will take about 5 to 10 minutes to complete each time. You may also be contacted at home so that researchers can follow-up on your experience with symptoms (only if you are not able to come to the clinic for your chemoradiation treatment or follow-up visits). If you are contacted by phone, the call should last about 5 to 10 minutes each time. Researchers will also try to collect some of your leftover blood (that was already drawn and stored for research studies) from a previous lung cancer study (Ecogenetics of Lung Cancer) that you participated in at M. D. Anderson. Researchers will use your leftover blood sample to look at certain genes in your blood that may affect your symptoms. If you did not have blood collected in the previous lung cancer study, you will have a blood sample (one tablespoon) drawn when you first agree to participate in this study. This is an investigational study. Up to 320 patients will take part in this study. All will be enrolled at M. D. Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.