Clinical Trial: Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Single-blind Study to Estimate the Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim

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 Summary:

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.

Current Primary Outcome: Maximum Patient-reported Bone Pain in Cycle 1 [ Time Frame: Days 1 to 5 during cycle 1. ]

Original Primary Outcome: Maximum subject-reported bone pain in cycle 1 [ Time Frame: up to 20 weeks ]

Current Secondary Outcome:

• Maximum Patient-reported Bone Pain by Cycle and Across All Cycles [ Time Frame: Days 1-5 for each treatment cycle ]
  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.
• Mean Patient-reported Bone Pain by Cycle and Across All Cycles [ Time Frame: Days 1-5 for 4 treatment 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.
• Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles [ Time Frame: Days 1-5 for 4 treatment 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.
• Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting [ Time Frame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks ]
  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.
• Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting [ Time Frame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks. ]

  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.

• Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles [ Time Frame: From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks. ]
  Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.

Original Secondary Outcome:

• Maximum subject-reported bone pain by cycle (2 thorugh 4) and across cycles (up to and including 4 cycles) [ Time Frame: up to 20 weeks ]
  To estimate the difference between arms in mean maximum severity of subject-reported bone pain by cycle and across all cycles (up to and including 4 cycles)
• Subject-reported bone pain by cycle and across cycles (up to and including 4 cycles) [ Time Frame: up to 20 weeks ]
  To estimate the difference between arms in mean subject-reported bone pain by cycle and across all cycles (up to and including 4 cycles)
• AUC for subject-reported bone pain by cycle and across all cycles (up to and including 4 cycles) [ Time Frame: up to 20 weeks ]
  To estimate the difference between arms in area under the curve (AUC) for subject reported bone pain by cycle and across all cycles (up to and including 4 cycles)
• Bone pain (all grade) by cycle and across cycles (up to and including 4 cycles) captured as part of AE reporting [ Time Frame: up to 20 weeks ]
  To estimate the difference between arms in bone pain (all grade) captured as part of adverse event (AE) reporting, by cycle and across cycles (up to and including 4 cycles)
• Severe (grade 3/4) bone pain by cycle and across cycles (up to and including 4 cycles) captured as part of AE reporting [ Time Frame: up to 20 weeks ]
  To estimate the difference between groups in severe (grade 3/4) bone pain captured as part of AE reporting, by cycle, and across cycles (up to and including 4 cycles)
• Use of analgesics for the treatment of bone pain by cycle and across cycles (up to and including 4 cycles) [ Time Frame: up to 20 weeks ]
  To characterize analgesic use for the treatment of bone pain by cycle, and across cycles (up to and including 4 cycles)

Dates:
Date Received: November 15, 2012
Date Started: January 2013
Date Completion:
Last Updated: December 6, 2015
Last Verified: December 2015