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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

304

Study ID:

NCT01752907

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 51 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

304

Study ID:

NCT01752907

Recruitment Status:

Completed

Sponsor:


Amgen

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