Clinical trial NCT01752907: Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
Official title: Randomized, Single-blind Study to Estimate the Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
Chemotherapy
Pegfilgrastim
Neulasta
Bone Pain
Education
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 304
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Primary outcomes:
measure: Maximum Patient-reported Bone Pain in Cycle 1
timeFrame: Days 1 to 5 during cycle 1.
Secondary outcomes:
measure: Maximum Patient-reported Bone Pain by Cycle and Across All Cycles
timeFrame: Days 1-5 for each treatment cycle
measure: Mean Patient-reported Bone Pain by Cycle and Across All Cycles
timeFrame: Days 1-5 for 4 treatment cycles
measure: Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles
timeFrame: Days 1-5 for 4 treatment cycles
measure: Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting
timeFrame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks
measure: Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting
timeFrame: From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.
measure: Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles
timeFrame: From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Mission Hills
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Vallejo
country: United States
facility: Research Site
state: California
city: Whittier
country: United States
facility: Research Site
state: California
city: Danbury
country: United States
facility: Research Site
state: Connecticut
city: Greenwich
country: United States
facility: Research Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Elk Grove Village
country: United States
facility: Research Site
state: Illinois
city: Naperville
country: United States
facility: Research Site
state: Illinois
city: Peoria
country: United States
facility: Research Site
state: Illinois
city: Cedar Rapids
country: United States
facility: Research Site
state: Iowa
city: Mason City
country: United States
facility: Research Site
state: Iowa
city: Mount Sterling
country: United States
facility: Research Site
state: Kentucky
city: Lewiston
country: United States
facility: Research Site
state: Maine
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Fairhaven
country: United States
facility: Research Site
state: Massachusetts
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Robbinsdale
country: United States
facility: Research Site
state: Minnesota
city: Saint Louis Park
country: United States
facility: Research Site
state: Minnesota
city: Jefferson City
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Portsmouth
country: United States
facility: Research Site
state: New Hampshire
city: Englewood
country: United States
facility: Research Site
state: New Jersey
city: Hamilton
country: United States
facility: Research Site
state: New Jersey
city: Morristown
country: United States
facility: Research Site
state: New Jersey
city: Vineland
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Cooperstown
country: United States
facility: Research Site
state: New York
city: Glens Falls
country: United States
facility: Research Site
state: New York
city: Poughkeepsie
country: United States
facility: Research Site
state: New York
city: Suffern
country: United States
facility: Research Site
state: New York
city: Asheboro
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Fayetteville
country: United States
facility: Research Site
state: North Carolina
city: Goldsboro
country: United States
facility: Research Site
state: North Carolina
city: Hendersonville
country: United States
facility: Research Site
state: North Carolina
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Massillon
country: United States
facility: Research Site
state: Ohio
city: Middletown
country: United States
facility: Research Site
state: Ohio
city: Bend
country: United States
facility: Research Site
state: Oregon
city: Gettysburg
country: United States
facility: Research Site
state: Pennsylvania
city: Langhorne
country: United States
facility: Research Site
state: Pennsylvania
city: Aberdeen
country: United States
facility: Research Site
state: South Dakota
city: Sioux Falls
country: United States
facility: Research Site
state: South Dakota
city: Bristol
country: United States
facility: Research Site
state: Tennessee
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Danville
country: United States
facility: Research Site
state: Virginia
city: Burien
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.