Randomized, Single-blind Study to Estimate the Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 304
- 试验地点
- 52
- 主要终点
- Maximum Patient-reported Bone Pain in Cycle 1
研究概览
简要总结
The purpose of this study is to determine if patient education can affect patient reported bone pain in breast cancer patients receiving chemotherapy and pegfilgrastim.
详细描述
In this study, the effect of patient education on reported bone pain in breast cancer patients receiving adjuvant or neoadjuvant chemotherapy and pegfilgrastim will be investigated.
Each patient will receive adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis, beginning in the first cycle and continuing throughout the study period. The study period for this study is the first 4 cycles of chemotherapy. participants can be planning to receive regimens with > 4 cycles, but data will only be collected for the first 4 cycles. The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician. Commercially available pegfilgrastim will be administered according to US Prescribing Information and is considered background therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over
- •Eastern cooperative oncology group (ECOG) performance status 0-2
- •Female with newly diagnosed, not previously treated with chemotherapy, stage I-III breast cancer
- •Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy
- •Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy and pegfilgrastim as determined by the investigator
- •Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the study period
- •Has provided informed consent
- •Able to understand the content of the DVD material, in investigator's opinion
- •Able to read and understand English
排除标准
- •Planning to receive weekly chemotherapy
- •Chronic use of oral non-steroidal anti-inflammatory drugs (NSAIDs) or oral antihistamines with the following exception:
- •Chronic oral aspirin use for cardiovascular-related indications
- •Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator
- •Chronic oral steroid use. Premedication related to the administration of taxanes, and use of anti-emetics is allowed, per usual clinical practice.
- •Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis
- •Prior use of granulocyte-colony stimulating factor (G-CSF)
- •Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony stimulating factor (GM-CSF) (sargramostim) use
- •Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)
- •Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer
- •Currently enrolled in, or less than 30 days since ending, any pain intervention study
结局指标
主要结局
Maximum Patient-reported Bone Pain in Cycle 1
时间窗: Days 1 to 5 during cycle 1.
Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.
次要结局
- Mean Patient-reported Bone Pain by Cycle and Across All Cycles(Days 1-5 for 4 treatment cycles)
- Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting(From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks)
- Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles(Days 1-5 for 4 treatment cycles)
- Maximum Patient-reported Bone Pain by Cycle and Across All Cycles(Days 1-5 for each treatment cycle)
- Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles(From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.)
- Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting(From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.)