NCT03936842

Evaluation of an Educational Intervention for Women With Breast Pain

Status unknown NA Last updated 3 May 2019

What this trial tests

NA trial testing Breast Pain video in Breast Pain in 15 participants. Status unknown.

Timeline

31 May 2019

Primary endpoint
31 July 2019

30 September 2019

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	15
Start date	31 May 2019
Primary completion	31 July 2019
Estimated completion	30 September 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Breast Pain video
• Semi-structure interviews

Conditions studied

• Breast Pain — all drugs for Breast Pain →
• Mastalgia — all drugs for Mastalgia →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

Adults 18 to 40, female only, with Breast Pain or Mastalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluation of an educational intervention for women with breast pain

Target Problem -Symptomatic breast pain Study Objectives- The primary objective is to obtain knowledge of women's perceptions of an educational video about breast pain, breast awareness and self-examination and its impact on their confidence in self-management of breast pain.

The secondary objectives -proportion of women who report that the video

1. Was informative
2. Might have reassured them enough not to have needed to seek an appointment in secondary care.

Study Design- Prospective single-centre mixed methods study through semi-structured interviews for Masters in Public Health thesis Trial Population -Women, aged 18-40, referred to "one-stop" / rapid diagnostic breast clinic at The Royal Marsden Hospital (RMH) with breast pain alone.

Recruitment target Until saturation, expected sample 10-15 Trial Design- Mixed methods study using semi-structured interviews Primary endpoint -This is a qualitative study, with no statistical primary end point.

Secondary endpoints-Descriptive summaries of two questions will be reported as a secondary end point.

Inclusion Criteria

* Women aged between 18 years and 40 years on the day of clinic attendance
* Breast pain as the only symptom
* Normal clinical examination
* No further investigation (imaging, biopsy etc) Exclusion Criteria
* Presence of suspicious features during clinical examination requiring further investigation
* Strong family history of breast cancer
* Previous breast imaging within last 12 months
* Previous history of breast cancer
* Current or previous treatment with Tamoxifen
* Concurrent cancer
* Medical or psychiatric illness which might impact their participation in the study

Publications & conference data

No peer-reviewed publications indexed yet for this trial.