Neuropathic Pain in Survivors of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Prevalence of neuropathic pain (NP) in breast cancer survivors
研究概览
简要总结
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:
- To assess the impact of NP on quality of life.
- To assess the current management of NP in cancer (current medication, duration of such treatment, reasons for discontinuation) and the outcomes of this management.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients who were participants in clinical trials (ID98-240; ID94-002) for taxanes during 1994-2001
- •Alive and with current contact information
- •Age ≥ 18 years. (This restriction is based on inclusion criteria for the clinical trials from which subjects will be recruited. All patients will be at least 18 years or older for this study.)
排除标准
- 未提供
结局指标
主要结局
Prevalence of neuropathic pain (NP) in breast cancer survivors
时间窗: 3 Years
Assessment of neuropathic pain will be standardized using two validated tools for this purpose: the self report version of the LANSS pain score (S-LANSS) \[Bennett 2001, Bennett et al 2004\] and ID Pain (IDP) \[Portenoy, et al, 2006\]. The S-LANSS is a 7-item instrument that identifies pain of predominantly neuropathic origin. A score of 10 or more (out of a maximum of 24), regarded as a "positive" score, identifies neuropathic pain with a sensitivity, specificity and positive predictive value all of 80%. It has been found to be valid and reliable in both clinical and mail-survey settings \[Bennett et al 2004\]. The IDP is a 6-item scale that assesses the quality of pain, and has been well-validated \[Portenoy, et al, 2006\].
次要结局
- Study of how much pain, factors related to the pain, and how the pain affects life(3 Years)