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Breast CancerPhase 2VINENCT01752907

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

A Phase 2 study testing General Education DVD and Bone Pain Education DVD in people with Breast Cancer, run by Amgen at 51 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
General Education DVD and Bone Pain Education DVD
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
51 sitesUnited States
Study dates
17 Jan 2013to 15 Dec 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Has provided informed consent
  • Able to understand the content of the DVD material, in investigator's opinion
  • Able to read and understand English

Who cannot join

  • 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
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  • 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

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • Research Site

    Aberdeen, South Dakota, 57401

  • Research Site

    Albuquerque, New Mexico, 87109-4397

  • Research Site

    Asheboro, North Carolina, 27203

  • Research Site

    Bend, Oregon, 97701

  • Research Site

    Boston, Massachusetts, 02135

  • Research Site

    Bristol, Tennessee, 37620

  • Research Site

    Burien, Washington, 98166

  • Research Site

    Canton, Ohio, 44708

  • Research Site

    Cedar Rapids, Iowa, 52403

  • Research Site

    Charlotte, North Carolina, 28204

  • Research Site

    Chicago, Illinois, 60616

  • Research Site

    Cooperstown, New York, 13326

  • Research Site

    Danbury, Connecticut, 06810

  • Research Site

    Danville, Virginia, 24541

  • Research Site

    El Paso, Texas, 79905

  • Research Site

    Elk Grove Village, Illinois, 60007

  • Research Site

    Englewood, New Jersey, 07631

  • Research Site

    Fairhaven, Massachusetts, 02719

  • Research Site

    Fayetteville, North Carolina, 28304

  • Research Site

    Fort Lauderdale, Florida, 33308

  • Research Site

    Fountain Valley, California, 92708

  • Research Site

    Gettysburg, Pennsylvania, 17325

  • Research Site

    Glens Falls, New York, 12801

  • Research Site

    Goldsboro, North Carolina, 27534

  • Research Site

    Greenwich, Connecticut, 06830

  • Research Site

    Hamilton, New Jersey, 08650

  • Research Site

    Hendersonville, North Carolina, 28791

  • Research Site

    Jefferson City, Missouri, 65109

  • Research Site

    Langhorne, Pennsylvania, 19047

  • Research Site

    Lansing, Michigan, 48912

  • Research Site

    Lewiston, Maine, 04240

  • Research Site

    Mason City, Iowa, 50401

  • Research Site

    Massillon, Ohio, 44646

  • Research Site

    Middletown, Ohio, 45042

  • Research Site

    Mission Hills, California, 91345

  • Research Site

    Morristown, New Jersey, 07960

  • Research Site

    Mount Sterling, Kentucky, 40353

  • Research Site

    Naperville, Illinois, 60540

  • Research Site

    Omaha, Nebraska, 68106

  • Research Site

    Peoria, Illinois, 61615

  • Research Site

    Portsmouth, New Hampshire, 03801

  • Research Site

    Poughkeepsie, New York, 12601

  • Research Site

    Robbinsdale, Minnesota, 55422

  • Research Site

    Saint Louis Park, Minnesota, 55426

  • Research Site

    Santa Rosa, California, 95403

  • Research Site

    Sioux Falls, South Dakota, 57105

  • Research Site

    St Louis, Missouri, 63136

  • Research Site

    Suffern, New York, 10901

  • Research Site

    Vallejo, California, 94589

  • Research Site

    Vineland, New Jersey, 08360

  • Research Site

    Whittier, California, 90603

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
General Education DVD, Bone Pain Education DVD
Keywords
Breast cancer, Chemotherapy, Pegfilgrastim, Neulasta, Bone Pain, Education
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • General Education DVDOther

    A general chemotherapy side effects education DVD

  • Bone Pain Education DVDOther

Study groups in NCT01752907
Study groupRoleWhat they receive
General Education DVDExperimentalParticipants 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.
Receives: Other: General Education DVD
Bone Pain Education DVDExperimentalParticipants 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.
Receives: Other: Bone Pain Education DVD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Days 1 to 5 during cycle 1.

Secondary outcomes (6)

  1. 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.

    Measured: Days 1-5 for each treatment cycle

  2. 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.

    Measured: Days 1-5 for 4 treatment cycles

  3. 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.

    Measured: Days 1-5 for 4 treatment cycles

  4. 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.

    Measured: From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks

  5. 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.

    Measured: From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.

  6. 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.

    Measured: From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2012 (estimated)
  2. Study start17 Jan 2013
  3. Primary completion15 Dec 2014
  4. Study completion15 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
304 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01752907
Sponsor's protocol ID
20110148
Acronym
VINE
Status last verified
Nov 2022
First submitted
15 Nov 2012
Last updated
29 Nov 2022
Data monitoring committee
No

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.

    PubMed 29935909

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing General Education DVD and Bone Pain Education DVD in people with Breast Cancer, run by Amgen at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Patient-reported Bone Pain in Cycle 1 (time frame: Days 1 to 5 during cycle 1.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01752907, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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