Evaluation of an Educational Intervention for Women With Breast Pain
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|ClinicalTrials.gov Identifier: NCT03936842|
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
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
- Was informative
- 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.
- 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
|Condition or disease||Intervention/treatment||Phase|
|Breast Pain Mastalgia||Behavioral: Breast Pain video Behavioral: Semi-structure interviews||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of an Educational Intervention for Women With Breast Pain|
|Estimated Study Start Date :||May 31, 2019|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Single Arm
Eligible patients who are referred to the "one-stop" diagnostic clinic with breast pain alone and have completed a clinical assessment will be given a patient information sheet inviting them to participate in the study. They will be met by the interviewing clinician at the same visit.
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.
- Patient's perceptions on the breast-pain video [ Time Frame: 10 minutes ]Due to the semi-structure interview qualitative nature of the study the primary objective is to obtain observational data for insights and patterns (through "quotes") 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.
- Video's purpose evaluation [ Time Frame: 10 minutes ]
proportion of women who report that the video
- Was informative
- Might have reassured them enough not to have needed to seek an appointment in secondary care
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936842
|Contact: Ann Gandolfifirstname.lastname@example.org|
|Contact: Jennifer Rusby, consultant||07957648248||Jennifer.Rusby@rmh.nhs.uk|
|Royal Marsden Hospital NHS Foundation Trust|
|London, United Kingdom, SW3 6JJ|