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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: General Education DVD
* Other: Bone Pain Education DVD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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 Exclusion Criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General Education DVD<br>Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1. | Other: General Education DVD<br>* A general chemotherapy side effects education DVD<br>|
| Experimental: Bone Pain Education DVD<br>Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1. | Other: Bone Pain Education DVD<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Days 1 to 5 during cycle 1. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Chemotherapy, Pegfilgrastim, Neulasta, Bone Pain, Education