Video Impact on Neulasta Education (VINE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01752907
First received: November 15, 2012
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to determine if patient education can affect patient reported bone pain in breast cancer patients receiving chemotherapy and Neulasta.


Condition Intervention Phase
Breast Cancer
Other: Educational DVD 1
Other: Educational DVD 2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Maximum subject-reported bone pain in cycle 1 [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
    To estimate the difference between arms in mean maximum severity of subject-reported bone pain in cycle 1


Secondary Outcome Measures:
  • Maximum subject-reported bone pain by cycle (2 through 4) and across cycles (up to and including 4 cycles) [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
    To estimate the difference between arms in mean maximum severity of subject-reported bone pain by cycle and across all cycles (up to and including 4 cycles)

  • Subject-reported bone pain by cycle and across cycles (up to and including 4 cycles) [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
    To estimate the difference between arms in mean subject-reported bone pain by cycle and across all cycles (up to and including 4 cycles)

  • AUC for subject-reported bone pain by cycle and across all cycles (up to and including 4 cycles) [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
    To estimate the difference between arms in area under the curve (AUC) for subject reported bone pain by cycle and across all cycles (up to and including 4 cycles)

  • Bone pain (all grade) by cycle and across cycles (up to and including 4 cycles) captured as part of AE reporting [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
    To estimate the difference between arms in bone pain (all grade) captured as part of adverse event (AE) reporting, by cycle and across cycles (up to and including 4 cycles)

  • Severe (grade 3/4) bone pain by cycle and across cycles (up to and including 4 cycles) captured as part of AE reporting [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
    To estimate the difference between groups in severe (grade 3/4) bone pain captured as part of AE reporting, by cycle, and across cycles (up to and including 4 cycles)

  • Use of analgesics for the treatment of bone pain by cycle and across cycles (up to and including 4 cycles) [ Time Frame: up to 20 weeks ] [ Designated as safety issue: No ]
    To characterize analgesic use for the treatment of bone pain by cycle, and across cycles (up to and including 4 cycles)


Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Educational DVD 1 Other: Educational DVD 1
Cycle 1 - Subject watches DVD twice at the clinic, on 2 separate days during any clinic visits up to and including the visit for pegfilgrastim administration
Experimental: Educational DVD 2 Other: Educational DVD 2
Cycle 1 - Subject watches DVD twice at the clinic, on 2 separate days during any clinic visits up to and including the visit for pegfilgrastim administration

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age 18 years or over
  • 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 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 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 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 NCCN Clinical Practice Guidelines in Oncology for Breast Cancer
  • Currently enrolled in, or less than 30 days since ending, any pain intervention study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752907

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 51 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01752907     History of Changes
Other Study ID Numbers: 20110148
Study First Received: November 15, 2012
Last Updated: October 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Amgen:
Breast cancer
Chemotherapy
Pegfilgrastim
Neulasta
Bone Pain
Education

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014