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

Breast Cancer Clinical Trial

— VINE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752907
• Other study ID #: 20110148
• Status: Completed
• Phase: Phase 2
• Start date: January 17, 2013
• Est. completion date: December 15, 2014

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 15, 2014
• Est. primary completion date: December 15, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Mastodynia

Intervention

Other:
• General Education DVD
A general chemotherapy side effects education DVD
• Bone Pain Education DVD

Locations

Country	Name	City	State
United States	Research Site	Aberdeen	South Dakota
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Asheboro	North Carolina
United States	Research Site	Bend	Oregon
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bristol	Tennessee
United States	Research Site	Burien	Washington
United States	Research Site	Canton	Ohio
United States	Research Site	Cedar Rapids	Iowa
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chicago	Illinois
United States	Research Site	Cooperstown	New York
United States	Research Site	Danbury	Connecticut
United States	Research Site	Danville	Virginia
United States	Research Site	El Paso	Texas
United States	Research Site	Elk Grove Village	Illinois
United States	Research Site	Englewood	New Jersey
United States	Research Site	Fairhaven	Massachusetts
United States	Research Site	Fayetteville	North Carolina
United States	Research Site	Fort Lauderdale	Florida
United States	Research Site	Fountain Valley	California
United States	Research Site	Gettysburg	Pennsylvania
United States	Research Site	Glens Falls	New York
United States	Research Site	Goldsboro	North Carolina
United States	Research Site	Greenwich	Connecticut
United States	Research Site	Hamilton	New Jersey
United States	Research Site	Hendersonville	North Carolina
United States	Research Site	Jefferson City	Missouri
United States	Research Site	Langhorne	Pennsylvania
United States	Research Site	Lansing	Michigan
United States	Research Site	Lewiston	Maine
United States	Research Site	Mason City	Iowa
United States	Research Site	Massillon	Ohio
United States	Research Site	Middletown	Ohio
United States	Research Site	Mission Hills	California
United States	Research Site	Morristown	New Jersey
United States	Research Site	Mount Sterling	Kentucky
United States	Research Site	Naperville	Illinois
United States	Research Site	Omaha	Nebraska
United States	Research Site	Peoria	Illinois
United States	Research Site	Portsmouth	New Hampshire
United States	Research Site	Poughkeepsie	New York
United States	Research Site	Robbinsdale	Minnesota
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Louis Park	Minnesota
United States	Research Site	Santa Rosa	California
United States	Research Site	Sioux Falls	South Dakota
United States	Research Site	Suffern	New York
United States	Research Site	Vallejo	California
United States	Research Site	Vineland	New Jersey
United States	Research Site	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Patient-reported Bone Pain by Cycle and Across All Cycles	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 1-5 for each treatment cycle
Secondary	Mean Patient-reported Bone Pain by Cycle and Across All Cycles	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 1-5 for 4 treatment cycles
Secondary	Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles	Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.	Days 1-5 for 4 treatment cycles
Secondary	Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting	Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.	From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks
Secondary	Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting	Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE.	From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.
Secondary	Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles	Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.	From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.

External Links

•   AmgenTrials clinical trials website