Randomized, Single-blind Study to Estimate the Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Amgen
- Enrollment
- 304
- Locations
- 1
- Primary Endpoint
- Maximum Patient-reported Bone Pain in Cycle 1
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximum Patient-reported Bone Pain in Cycle 1
Time Frame: 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.
Secondary Outcomes
- 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.)