MastodyniaNCT02515253
A Breast Support Intervention for Women With Breast Pain
A study testing Bra prescription in people with Mastodynia, run by University of Portsmouth at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Mastodynia
- What is being tested?
- Bra prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Sport and Exercise Science, University of Portsmouth
Portsmouth, PO1 2ER
Breast Care Services, Queen Alexandra Hospital
Portsmouth, PO6 3LY
About this study
Official title: 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.
- Conditions
- Mastodynia
- Being tested
- Bra prescription, Standard Care
- Keywords
- Breast Pain, Mastalgia, Bras, Breast Support
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bra prescriptionOther
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: eight weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MastodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Responsible party
- Principal investigator, Emma Burnett, University of Portsmouth
- Investigators
- Emma Burnett, MRes, Principal investigator, University of PortsmouthJoanna Scurr, PhD, Study chair, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515253
- Sponsor's protocol ID
- BP-01
- Status last verified
- Aug 2019
- First submitted
- 27 Jul 2015
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of an Individual Bra Prescription Versus Standard Care for Women With Larger Breasts and Breast Pain
- ClinicalTrials.gov ID
- NCT02515253
- Acronym / sponsor ID
- BP-01
- Conditions
- Mastodynia
- Keywords
- Breast Pain, Mastalgia, Bras, Breast Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Aug 2015 (estimated)
- Results
- Posted 7 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescription group | Experimental | Other: Bra prescription, Other: Standard CareParticipants 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. |
| Standard care group | Other | Other: Standard CareParticipants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bra prescription | Other | Prescription group |
| Standard Care | Other | Prescription group, Standard care group |
Primary outcome
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)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Burnett, MRes principal investigator
University of Portsmouth
Joanna Scurr, PhD study chair
University of Portsmouth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bra prescription in people with Mastodynia, run by University of Portsmouth at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Change (PGIC) (time frame: four weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.