Breast Cancer Clinical Trial
Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
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.
Full Description
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.
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
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There are 51 Locations for this study
Fountain Valley California, 92708, United States
Mission Hills California, 91345, United States
Santa Rosa California, 95403, United States
Vallejo California, 94589, United States
Whittier California, 90603, United States
Danbury Connecticut, 06810, United States
Greenwich Connecticut, 06830, United States
Fort Lauderdale Florida, 33308, United States
Chicago Illinois, 60616, United States
Elk Grove Village Illinois, 60007, United States
Naperville Illinois, 60540, United States
Peoria Illinois, 61615, United States
Cedar Rapids Iowa, 52403, United States
Mason City Iowa, 50401, United States
Mount Sterling Kentucky, 40353, United States
Lewiston Maine, 04240, United States
Boston Massachusetts, 02135, United States
Fairhaven Massachusetts, 02719, United States
Lansing Michigan, 48912, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55426, United States
Jefferson City Missouri, 65109, United States
Saint Louis Missouri, 63136, United States
Omaha Nebraska, 68106, United States
Portsmouth New Hampshire, 03801, United States
Englewood New Jersey, 07631, United States
Hamilton New Jersey, 08650, United States
Morristown New Jersey, 07960, United States
Vineland New Jersey, 08360, United States
Albuquerque New Mexico, 87109, United States
Cooperstown New York, 13326, United States
Glens Falls New York, 12801, United States
Poughkeepsie New York, 12601, United States
Suffern New York, 10901, United States
Asheboro North Carolina, 27203, United States
Charlotte North Carolina, 28204, United States
Fayetteville North Carolina, 28304, United States
Goldsboro North Carolina, 27534, United States
Hendersonville North Carolina, 28791, United States
Canton Ohio, 44708, United States
Massillon Ohio, 44646, United States
Middletown Ohio, 45042, United States
Bend Oregon, 97701, United States
Gettysburg Pennsylvania, 17325, United States
Langhorne Pennsylvania, 19047, United States
Aberdeen South Dakota, 57401, United States
Sioux Falls South Dakota, 57105, United States
Bristol Tennessee, 37620, United States
El Paso Texas, 79905, United States
Danville Virginia, 24541, United States
Burien Washington, 98166, United States
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