Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
VINE
Randomized, Single-blind Study to Estimate the Effect of Patient Education on Reported Bone Pain in Breast Cancer Patients Receiving Chemotherapy and Pegfilgrastim
1 other identifier
interventional
304
1 country
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jan 2013
Shorter than P25 for phase_2 breast-cancer
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2012
CompletedFirst Posted
Study publicly available on registry
December 19, 2012
CompletedStudy Start
First participant enrolled
January 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2014
CompletedResults Posted
Study results publicly available
January 11, 2016
CompletedNovember 29, 2022
November 1, 2022
1.9 years
November 15, 2012
December 6, 2015
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Patient-reported Bone Pain in Cycle 1
Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.
Days 1 to 5 during cycle 1.
Secondary Outcomes (6)
Maximum Patient-reported Bone Pain by Cycle and Across All Cycles
Days 1-5 for each treatment cycle
Mean Patient-reported Bone Pain by Cycle and Across All Cycles
Days 1-5 for 4 treatment cycles
Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles
Days 1-5 for 4 treatment cycles
Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting
From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks
Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting
From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.
- +1 more secondary outcomes
Study Arms (2)
General Education DVD
EXPERIMENTALParticipants 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.
Bone Pain Education DVD
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (51)
Research Site
Fountain Valley, California, 92708, United States
Research Site
Mission Hills, California, 91345, United States
Research Site
Santa Rosa, California, 95403, United States
Research Site
Vallejo, California, 94589, United States
Research Site
Whittier, California, 90603, United States
Research Site
Danbury, Connecticut, 06810, United States
Research Site
Greenwich, Connecticut, 06830, United States
Research Site
Fort Lauderdale, Florida, 33308, United States
Research Site
Chicago, Illinois, 60616, United States
Research Site
Elk Grove Village, Illinois, 60007, United States
Research Site
Naperville, Illinois, 60540, United States
Research Site
Peoria, Illinois, 61615, United States
Research Site
Cedar Rapids, Iowa, 52403, United States
Research Site
Mason City, Iowa, 50401, United States
Research Site
Mount Sterling, Kentucky, 40353, United States
Research Site
Lewiston, Maine, 04240, United States
Research Site
Boston, Massachusetts, 02135, United States
Research Site
Fairhaven, Massachusetts, 02719, United States
Research Site
Lansing, Michigan, 48912, United States
Research Site
Robbinsdale, Minnesota, 55422, United States
Research Site
Saint Louis Park, Minnesota, 55426, United States
Research Site
Jefferson City, Missouri, 65109, United States
Research Site
St Louis, Missouri, 63136, United States
Research Site
Omaha, Nebraska, 68106, United States
Research Site
Portsmouth, New Hampshire, 03801, United States
Research Site
Englewood, New Jersey, 07631, United States
Research Site
Hamilton, New Jersey, 08650, United States
Research Site
Morristown, New Jersey, 07960, United States
Research Site
Vineland, New Jersey, 08360, United States
Research Site
Albuquerque, New Mexico, 87109-4397, United States
Research Site
Cooperstown, New York, 13326, United States
Research Site
Glens Falls, New York, 12801, United States
Research Site
Poughkeepsie, New York, 12601, United States
Research Site
Suffern, New York, 10901, United States
Research Site
Asheboro, North Carolina, 27203, United States
Research Site
Charlotte, North Carolina, 28204, United States
Research Site
Fayetteville, North Carolina, 28304, United States
Research Site
Goldsboro, North Carolina, 27534, United States
Research Site
Hendersonville, North Carolina, 28791, United States
Research Site
Canton, Ohio, 44708, United States
Research Site
Massillon, Ohio, 44646, United States
Research Site
Middletown, Ohio, 45042, United States
Research Site
Bend, Oregon, 97701, United States
Research Site
Gettysburg, Pennsylvania, 17325, United States
Research Site
Langhorne, Pennsylvania, 19047, United States
Research Site
Aberdeen, South Dakota, 57401, United States
Research Site
Sioux Falls, South Dakota, 57105, United States
Research Site
Bristol, Tennessee, 37620, United States
Research Site
El Paso, Texas, 79905, United States
Research Site
Danville, Virginia, 24541, United States
Research Site
Burien, Washington, 98166, United States
Related Publications (1)
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.
PMID: 29935909BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2012
First Posted
December 19, 2012
Study Start
January 17, 2013
Primary Completion
December 15, 2014
Study Completion
December 15, 2014
Last Updated
November 29, 2022
Results First Posted
January 11, 2016
Record last verified: 2022-11