A Breast Support Intervention for Women With Breast Pain

NCT02515253 | Completed Results

• 1 other identifier: BP-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Mastodynia

Keywords

Breast Pain; Mastalgia; Bras; Breast Support

Outcome Measures

Primary Outcomes (2)

• 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 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)

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

  eight weeks post intervention

Study Arms (2)

Prescription group

EXPERIMENTAL

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; Other: Standard Care

Standard care group

OTHER

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

Interventions

Bra prescription OTHER

Prescription group

Standard Care OTHER

Prescription group; Standard care group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Portsmouth: lead
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (2)

Department of Sport and Exercise Science, University of Portsmouth

Portsmouth, PO1 2ER, United Kingdom

Location

Breast Care Services, Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Mastodynia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr Emma Sharland
• Organization: University of Portsmouth

emma.sharland@port.ac.uk

Study Officials

• Emma Burnett, MRes

  University of Portsmouth

  PRINCIPAL INVESTIGATOR

• Joanna Scurr, PhD

  University of Portsmouth

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Student

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: August 4, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 9, 2019
• Results First Posted: August 7, 2019

Record last verified: 2019-08

Locations

GB (2)