Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer
Longitudinal Study of the Prevalence, Severity, and Interference of Multiple Symptoms in Advanced Lung Cancer
1 other identifier
observational
204
1 country
4
Brief Summary
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:
- Polymorphisms in NER genes that modulate DNA repair capacity will also effect response to chemotherapy and to outcome.
- Cytokine gene polymorphisms account for variations in symptom outcomes (specific symptoms and symptom clusters) before, during and after chemotherapy.
- The COMT val/met polymorphism affects the metabolism of catecholamines on the modulation of response to sustained pain.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2003
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 12, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 2, 2012
August 1, 2012
7.1 years
January 12, 2007
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Longitudinal Data on Symptom Patterns + Severity
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.
Total weekly IVR assessment period 18 weeks, generally include 6 cycles of chemotherapy and 2-3 assessments of response to chemotherapy.
Study Arms (1)
Chemotherapy Symptoms
Study participants with advanced-stage lung cancer.
Interventions
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.
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.
Eligibility Criteria
Study participants with advanced-stage lung cancer and disease- or treatment-related symptoms.
You may qualify if:
- Is an adult \> 18 years of age
- Is diagnosed with Stage III or IV Lung cancer
- Is scheduled for a new chemotherapy regimen. Patients who have received prior chemotherapy are eligible.
- Is English- or Spanish-speaking
- Currently lives in the United States
You may not qualify if:
- Does not have access to telephones
- Is unable to use the telephone interactive system
- Has a current diagnosis of psychosis or dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (4)
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xin Shelley Wang, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2007
First Posted
January 17, 2007
Study Start
November 1, 2003
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 2, 2012
Record last verified: 2012-08