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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:January 2013
End Date:December 2014

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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

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.

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
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