Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
NCT ID: NCT01752907
Last Updated: 2022-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
304 participants
INTERVENTIONAL
2013-01-17
2014-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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General Education DVD
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.
General Education DVD
A general chemotherapy side effects education DVD
Bone Pain Education DVD
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.
Bone Pain Education DVD
Interventions
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General Education DVD
A general chemotherapy side effects education DVD
Bone Pain Education DVD
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Fountain Valley, California, United States
Research Site
Mission Hills, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Vallejo, California, United States
Research Site
Whittier, California, United States
Research Site
Danbury, Connecticut, United States
Research Site
Greenwich, Connecticut, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Elk Grove Village, Illinois, United States
Research Site
Naperville, Illinois, United States
Research Site
Peoria, Illinois, United States
Research Site
Cedar Rapids, Iowa, United States
Research Site
Mason City, Iowa, United States
Research Site
Mount Sterling, Kentucky, United States
Research Site
Lewiston, Maine, United States
Research Site
Boston, Massachusetts, United States
Research Site
Fairhaven, Massachusetts, United States
Research Site
Lansing, Michigan, United States
Research Site
Robbinsdale, Minnesota, United States
Research Site
Saint Louis Park, Minnesota, United States
Research Site
Jefferson City, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Omaha, Nebraska, United States
Research Site
Portsmouth, New Hampshire, United States
Research Site
Englewood, New Jersey, United States
Research Site
Hamilton, New Jersey, United States
Research Site
Morristown, New Jersey, United States
Research Site
Vineland, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Cooperstown, New York, United States
Research Site
Glens Falls, New York, United States
Research Site
Poughkeepsie, New York, United States
Research Site
Suffern, New York, United States
Research Site
Asheboro, North Carolina, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Fayetteville, North Carolina, United States
Research Site
Goldsboro, North Carolina, United States
Research Site
Hendersonville, North Carolina, United States
Research Site
Canton, Ohio, United States
Research Site
Massillon, Ohio, United States
Research Site
Middletown, Ohio, United States
Research Site
Bend, Oregon, United States
Research Site
Gettysburg, Pennsylvania, United States
Research Site
Langhorne, Pennsylvania, United States
Research Site
Aberdeen, South Dakota, United States
Research Site
Sioux Falls, South Dakota, United States
Research Site
Bristol, Tennessee, United States
Research Site
El Paso, Texas, United States
Research Site
Danville, Virginia, United States
Research Site
Burien, Washington, United States
Countries
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References
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Guinigundo AS, Maxwell CL, Vanni L, Morrow PK, Reiner M, Shih A, Klippel Z, Blanchard E. A Randomized, Single-Blind Study Evaluating the Effect of a Bone Pain Education Video on Reported Bone Pain in Patients with Breast Cancer Receiving Chemotherapy and Pegfilgrastim. Pain Manag Nurs. 2018 Dec;19(6):693-706. doi: 10.1016/j.pmn.2018.04.002. Epub 2018 Jun 21.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20110148
Identifier Type: -
Identifier Source: org_study_id
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