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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01752907

Run by

Amgen

People needed

304

Starts

2013-01-17

Expected to finish

2014-12-15

Last updated by the study team

2022-11-29

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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