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Evaluation of an Educational Intervention for Women With Breast Pain

NCT03936842 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-05-03

No results posted yet for this study

Summary

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

Conditions

  • Breast Pain
  • Mastalgia

Interventions

BEHAVIORAL

Breast Pain video

An educational video of approximately 10 minutes about breast pain, self-examination and breast awareness will be shown to the participant.

BEHAVIORAL

Semi-structure interviews

A semi-structured, face-to-face interview will be then undertaken. The principles of Grounded Theory will be used to guide the interview. All of the interviews will be recorded and transcribed securely, only referencing the patient according to their study number. Their name and hospital number will not be used.

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2019-07-31
Completion
2019-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03936842 on ClinicalTrials.gov