Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Mastodynia
Intervention: General Education DVD; Bone Pain Education DVD
Intervention description: A general chemotherapy side effects education DVD
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 304.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Breast cancer; Chemotherapy; Pegfilgrastim; Neulasta; Bone Pain; Education

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.
    

Eligibility criteria:

        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