Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422500
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2007-01-12
Brief Title:
Longitudinal Study of Multiple Symptoms in Advanced Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Longitudinal Study of the Prevalence Severity and Interference of Multiple Symptoms in Advanced Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients reported symptom interference and functional impairment
To compare symptom severity adequacy of symptom management and interference with affective status and health-related function by patients 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 valmet 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
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 patients reported symptom interference and functional impairment
To compare symptom severity adequacy of symptom management and interference with affective status and health-related function by patients 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 valmet 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
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 caregivers 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
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 caregivers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None