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A Breast Support Intervention for Women With Breast Pain

Primary Purpose

Mastodynia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bra prescription
Standard Care
Sponsored by
University of Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mastodynia focused on measuring Breast Pain, Mastalgia, Bras, Breast Support

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Sport and Exercise Science, University of Portsmouth
  • Breast Care Services, Queen Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Prescription group

Standard care group

Arm Description

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.

Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth.

Outcomes

Primary Outcome Measures

Patient Global Impression of Change (PGIC)
Participants will complete the PGIC as part of a questionnaire four weeks after receiving their treatment for benign breast pain = Very much improved (better outcome) = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse (worse outcome)
Patient Global Impression of Change (PGIC)
Participants will complete the PGIC as part of a questionnaire eight weeks after receiving their treatment for benign breast pain

Secondary Outcome Measures

Full Information

First Posted
July 27, 2015
Last Updated
August 26, 2019
Sponsor
University of Portsmouth
Collaborators
Portsmouth Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02515253
Brief Title
A Breast Support Intervention for Women With Breast Pain
Official Title
A Randomised Control Trial of an Individual Bra Prescription Versus Standard Care for Women With Larger Breasts and Breast Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Portsmouth
Collaborators
Portsmouth Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastodynia
Keywords
Breast Pain, Mastalgia, Bras, Breast Support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prescription group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care group
Arm Type
Other
Arm Description
Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth.
Intervention Type
Other
Intervention Name(s)
Bra prescription
Intervention Type
Other
Intervention Name(s)
Standard Care
Primary Outcome Measure Information:
Title
Patient Global Impression of Change (PGIC)
Description
Participants will complete the PGIC as part of a questionnaire four weeks after receiving their treatment for benign breast pain = Very much improved (better outcome) = Much improved = Minimally improved = No change = Minimally worse = Much worse = Very much worse (worse outcome)
Time Frame
four weeks post intervention
Title
Patient Global Impression of Change (PGIC)
Description
Participants will complete the PGIC as part of a questionnaire eight weeks after receiving their treatment for benign breast pain
Time Frame
eight weeks post intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Burnett, MRes
Organizational Affiliation
University of Portsmouth
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanna Scurr, PhD
Organizational Affiliation
University of Portsmouth
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Sport and Exercise Science, University of Portsmouth
City
Portsmouth
ZIP/Postal Code
PO1 2ER
Country
United Kingdom
Facility Name
Breast Care Services, Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom

12. IPD Sharing Statement

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A Breast Support Intervention for Women With Breast Pain

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