Clinical trial NCT02515253: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mastodynia
Keywords: Breast Pain
Mastalgia
Bras
Breast Support
Lead sponsor: University of Portsmouth
Sponsor class: OTHER
Collaborators: name: Portsmouth Hospitals NHS Trust
First posted: 2015-08-04
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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).

Primary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: four weeks post intervention
measure: Patient Global Impression of Change (PGIC)
timeFrame: eight weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Department of Sport and Exercise Science, University of Portsmouth
city: Portsmouth
country: United Kingdom
facility: Breast Care Services, Queen Alexandra Hospital
Study officials:
affiliation: University of Portsmouth
name: Emma Burnett, MRes
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Portsmouth
name: Joanna Scurr, PhD
role: STUDY_CHAIR
References: