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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: General Education DVD; Other: Bone Pain Education DVD

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.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Research Site
    • Mission Hills, California, United States, 91345
      • Research Site
    • Santa Rosa, California, United States, 95403
      • Research Site
    • Vallejo, California, United States, 94589
      • Research Site
    • Whittier, California, United States, 90603
      • Research Site
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Research Site
    • Greenwich, Connecticut, United States, 06830
      • Research Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Research Site
    • Elk Grove Village, Illinois, United States, 60007
      • Research Site
    • Naperville, Illinois, United States, 60540
      • Research Site
    • Peoria, Illinois, United States, 61615
      • Research Site
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Research Site
    • Mason City, Iowa, United States, 50401
      • Research Site
  • Kentucky
    • Mount Sterling, Kentucky, United States, 40353
      • Research Site
  • Maine
    • Lewiston, Maine, United States, 04240
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Research Site
    • Fairhaven, Massachusetts, United States, 02719
      • Research Site
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Research Site
  • Minnesota
    • Robbinsdale, Minnesota, United States, 55422
      • Research Site
    • Saint Louis Park, Minnesota, United States, 55426
      • Research Site
  • Missouri
    • Jefferson City, Missouri, United States, 65109
      • Research Site
    • Saint Louis, Missouri, United States, 63136
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • Research Site
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Research Site
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Research Site
    • Hamilton, New Jersey, United States, 08650
      • Research Site
    • Morristown, New Jersey, United States, 07960
      • Research Site
    • Vineland, New Jersey, United States, 08360
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109-4397
      • Research Site
  • New York
    • Cooperstown, New York, United States, 13326
      • Research Site
    • Glens Falls, New York, United States, 12801
      • Research Site
    • Poughkeepsie, New York, United States, 12601
      • Research Site
    • Suffern, New York, United States, 10901
      • Research Site
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Research Site
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Fayetteville, North Carolina, United States, 28304
      • Research Site
    • Goldsboro, North Carolina, United States, 27534
      • Research Site
    • Hendersonville, North Carolina, United States, 28791
      • Research Site
  • Ohio
    • Canton, Ohio, United States, 44708
      • Research Site
    • Massillon, Ohio, United States, 44646
      • Research Site
    • Middletown, Ohio, United States, 45042
      • Research Site
  • Oregon
    • Bend, Oregon, United States, 97701
      • Research Site
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Research Site
    • Langhorne, Pennsylvania, United States, 19047
      • Research Site
  • South Dakota
    • Aberdeen, South Dakota, United States, 57401
      • Research Site
    • Sioux Falls, South Dakota, United States, 57105
      • Research Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Research Site
  • Texas
    • El Paso, Texas, United States, 79905
      • Research Site
  • Virginia
    • Danville, Virginia, United States, 24541
      • Research Site
  • Washington
    • Burien, Washington, United States, 98166
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: General Education DVD; A general chemotherapy side effects education DVD
Experimental: 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.	Other: Bone Pain Education DVD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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.
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.

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2013
• Primary Completion (Actual): December 15, 2014
• Study Completion (Actual): December 15, 2014

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Breast cancer; Chemotherapy; Education; Pegfilgrastim; Neulasta; Bone Pain
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Mastodynia
• Other Study ID Numbers: 20110148