A Breast Support Intervention for Women With Breast Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Mastodynia

Intervention / Treatment
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* Other: Bra prescription
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prescription group<br>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: Bra prescription<br> <br> Other: Standard Care<br> <br> |
| Other: Standard care group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | four weeks post intervention | 
| 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 | eight weeks post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Pain, Mastalgia, Bras, Breast Support