A Breast Support Intervention for Women With Breast Pain

August 26, 2019 updated by: Emma Burnett, University of Portsmouth

A Randomised Control Trial of an Individual Bra Prescription Versus Standard Care for Women With Larger Breasts and Breast Pain

The purpose of this study is to assess whether prescribing a bra to participants results in an improvement in the Patient Global Impression of Change (PGIC) compared to participants who receive standard care alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Portsmouth, United Kingdom, PO1 2ER
        • Department of Sport and Exercise Science, University of Portsmouth
      • Portsmouth, United Kingdom, PO6 3LY
        • Breast Care Services, Queen Alexandra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, aged 18 years of age and above.
  • Experiencing breast pain of any severity.
  • Participants must be able to speak and read English fluently
  • Participants must be a resident within the local area and not planning to move out of the area within the study timeline
  • Participant must have attended the Queen Alexandra (QA) hospital for an assessment of their breast pain.
  • Participant is willing and able to give informed consent for participation in the study.
  • Participant is self-reported to be between a 34 and 40 under band size and a DD to G bra cup size.
  • Able to walk on a treadmill for up to two minutes unaided and be able to walk unaided up and down a small set of steps (assessed verbally by the clinicians at QA hospital)
  • Participants must be able to comply with the study procedures

Exclusion Criteria:

  • Participants are receiving any additional treatment for their breast pain that is not part of standard care (recommendation for a bra fit, topical ibuprofen, breast pain leaflet) including any cancer treatment
  • Participants have had any surgery to the breasts within the last year
  • Participants are currently pregnant or have been pregnant or breast fed in the past year
  • Planning to undertake any activities or lifestyle changes which may affect their levels of breast pain e.g. trying for a baby, changing oral contraceptive, having breast surgery.
  • Participant's data will be excluded from the analysis if they do not complete either survey at four or eight weeks (at least one follow up survey needs to be completed).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prescription group
Participants in this group will receive the standard care for benign breast pain sufferers (administered by the Queen Alexandra Hospital in Portsmouth) and will also attend the Department of Sport and Exercise Science at the University of Portsmouth for an individual bra prescription. Participants will be prescribed an appropriate bra to wear over an eight week intervention period.
Other: Standard Care
Other: Bra prescription
OTHER: Standard care group
Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth.
Other: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change (PGIC)
Time Frame: four weeks post intervention

Participants will complete the PGIC as part of a questionnaire four weeks after receiving their treatment for benign breast pain

  1. = Very much improved (better outcome)
  2. = Much improved
  3. = Minimally improved
  4. = No change
  5. = Minimally worse
  6. = Much worse
  7. = Very much worse (worse outcome)
four weeks post intervention
Patient Global Impression of Change (PGIC)
Time Frame: eight weeks post intervention
Participants will complete the PGIC as part of a questionnaire eight weeks after receiving their treatment for benign breast pain
eight weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Portsmouth

Collaborators

Portsmouth Hospitals NHS Trust

Investigators

  • Principal Investigator: Emma Burnett, MRes, University of Portsmouth
  • Study Chair: Joanna Scurr, PhD, University of Portsmouth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

August 3, 2015

First Posted (ESTIMATE)

August 4, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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