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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
304
A general chemotherapy side effects education DVD
Maximum Patient-reported Bone Pain in 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.
Time frame: Days 1 to 5 during cycle 1.
Maximum Patient-reported Bone Pain by Cycle and Across All Cycles
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.
Time frame: Days 1-5 for each treatment cycle
Mean Patient-reported Bone Pain by Cycle and Across All Cycles
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.
Time frame: Days 1-5 for 4 treatment cycles
Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles
Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.
Time frame: Days 1-5 for 4 treatment cycles
Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting
Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.
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Research Site
Fountain Valley, California, United States
Research Site
Mission Hills, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Vallejo, California, United States
Research Site
Whittier, California, United States
Research Site
Danbury, Connecticut, United States
Research Site
Greenwich, Connecticut, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Elk Grove Village, Illinois, United States
...and 41 more locations
Time frame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks
Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting
Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.
Time frame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.
Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles
Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.
Time frame: From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.