Trial Outcomes & Findings for A Breast Support Intervention for Women With Breast Pain (NCT NCT02515253)

NCT ID: NCT02515253

Last Updated: 2019-09-09

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: four weeks post intervention
• Results posted on: 2019-09-09

Participant Flow

Participant milestones

Measure	Prescription Group 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. Bra prescription Standard Care	Standard Care Group Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth. Standard Care
Overall Study STARTED	17	16
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Prescription Group n=10 Participants 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. Bra prescription Standard Care	Standard Care Group n=8 Participants Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth. Standard Care	Total n=18 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 9 • n=10 Participants	32 years STANDARD_DEVIATION 6 • n=8 Participants	39 years STANDARD_DEVIATION 10 • n=18 Participants
Sex: Female, Male Female	10 Participants n=10 Participants	8 Participants n=8 Participants	18 Participants n=18 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=18 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Breast Pain	6 scores on a scale STANDARD_DEVIATION 2 • n=10 Participants	2 scores on a scale STANDARD_DEVIATION 2 • n=8 Participants	6 scores on a scale STANDARD_DEVIATION 2 • n=18 Participants
Quality of Life (Physical Component Summary)	49.3 scores on a scale STANDARD_DEVIATION 7.4 • n=10 Participants	55.0 scores on a scale STANDARD_DEVIATION 5.7 • n=8 Participants	51.8 scores on a scale STANDARD_DEVIATION 7.1 • n=18 Participants
Quality of Life (Mental Component Summary)	45.6 MCS score STANDARD_DEVIATION 9.6 • n=10 Participants	44.8 MCS score STANDARD_DEVIATION 8.8 • n=8 Participants	45.2 MCS score STANDARD_DEVIATION 9.0 • n=18 Participants

PRIMARY outcome

Timeframe: four weeks post intervention

Population: Percentage of those who scored "Very much improved" or "much improved" in each group

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)

Outcome measures

Measure	Prescription Group n=9 Participants 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. Bra prescription Standard Care	Standard Care Group n=8 Participants Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth. Standard Care
Patient Global Impression of Change (PGIC)	55 percentage of VMI/MI respondents	25 percentage of VMI/MI respondents

PRIMARY outcome

Timeframe: eight weeks post intervention

Population: Percentage of those scoring "very much improved" or "much improved"

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

Outcome measures

Measure	Prescription Group n=10 Participants 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. Bra prescription Standard Care	Standard Care Group n=8 Participants Participants in this group will receive the standard care for benign breast pain sufferers administered by the Queen Alexandra Hospital in Portsmouth. Standard Care
Patient Global Impression of Change (PGIC)	50 percentage	25 percentage

Adverse Events

Prescription Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Emma Sharland

University of Portsmouth

Email: emma.sharland@port.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place