Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT00535067
Status:
COMPLETED
Last Update Posted:
2015-01-09
First Post:
2007-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropathic Pain in Survivors of Breast Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Neuropathic Pain in Survivors of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2015-01
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:
The objectives of this study are to: 1) describe the prevalence of neuropathic pain (NP) in breast cancer survivors and 2) to develop preliminary statistical risk models for predicting the risk for NP incorporating disease-related variables (e.g., stage of disease, location of tumor), treatment variables (chemotherapy, dose, duration; and other cancer therapy), clinical health status (e.g., comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race).
Researchers will also gather data to answer the following secondary aims:
1. To assess the impact of NP on quality of life.
2. To assess the current management of NP in cancer (current medication, duration of such treatment, reasons for discontinuation) and the outcomes of this management.
Researchers will also gather data to answer the following secondary aims:
1. To assess the impact of NP on quality of life.
2. To assess the current management of NP in cancer (current medication, duration of such treatment, reasons for discontinuation) and the outcomes of this management.
Detailed Description:
You have already been contacted by phone about participating in this study. You have received study documents (this consent and the study questionnaires) because you said over the phone that you would like to participate in this study.
In this study you will be asked to complete questionnaires that will ask about any pain you may be experiencing and about the quality of your life. These questionnaires will also ask for demographic information (such as age, race, and sex) and about your health. It should take about 1 hour to complete all of the questionnaires. In addition to the questionnaires, you will also be asked questions about any medications you may currently be taking for pain. All of the information you include on the questionnaires will be kept confidential. There are no right or wrong answers to the questions. A postage-paid return envelope has been provided for you to return this consent and the questionnaires.
Researchers are interested in how pain is related to certain treatments and medical conditions. As part of this study, researchers will review your medical records to see what type of cancer treatment you received and whether you had any pain related to the treatment. They will also see if you had any non-cancer health conditions that may have affected pain and quality of life.
This survey is for research purposes only. Your healthcare provider will not be informed of your responses to this survey. If you are experiencing severe pain and/or other symptoms, please contact your healthcare provider. The study staff has also included a list of community resources that you may contact for different types of services.
Your participation in this study will be over once you mail back the consent and questionnaires.
This is an investigational study. Up to 635 individuals will be asked to take part in this study. All will be enrolled at M. D. Anderson.
In this study you will be asked to complete questionnaires that will ask about any pain you may be experiencing and about the quality of your life. These questionnaires will also ask for demographic information (such as age, race, and sex) and about your health. It should take about 1 hour to complete all of the questionnaires. In addition to the questionnaires, you will also be asked questions about any medications you may currently be taking for pain. All of the information you include on the questionnaires will be kept confidential. There are no right or wrong answers to the questions. A postage-paid return envelope has been provided for you to return this consent and the questionnaires.
Researchers are interested in how pain is related to certain treatments and medical conditions. As part of this study, researchers will review your medical records to see what type of cancer treatment you received and whether you had any pain related to the treatment. They will also see if you had any non-cancer health conditions that may have affected pain and quality of life.
This survey is for research purposes only. Your healthcare provider will not be informed of your responses to this survey. If you are experiencing severe pain and/or other symptoms, please contact your healthcare provider. The study staff has also included a list of community resources that you may contact for different types of services.
Your participation in this study will be over once you mail back the consent and questionnaires.
This is an investigational study. Up to 635 individuals will be asked to take part in this study. All will be enrolled at M. D. Anderson.
Study Oversight
Has Oversight DMC:
False
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?: