Breast Pain Clinical Trial
Official title:
Evaluation of an Educational Intervention for Women With Breast Pain
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
The prevalence of breast pain has been reported to be between 41-69% in clinical cohorts and
in the general population (1-4). The incidence of cancer in women with breast pain alone (ie
no lump or other, more concerning symptoms) is low, with published rates between 1 to 1.8%
(7-9).
Furthermore, the prevalence of breast pain increases linearly up to the age of 50 and then
decreases (4), thus women under 40 with a normal clinical examination do not require further
investigations and can be reassured in primary care.
Despite this, mastalgia is one of the most common symptoms in women referred to a breast unit
representing up to 69% of attendances (5-7). Consequently, women affected by breast pain are
up to 4.7 times more likely to have had a mammogram than asymptomatic women (6). ln order to
facilitate early breast cancer diagnosis there is a suspected cancer pathway referral (for an
appointment within 2 weeks) from primary care to specialist units. Recent increases in breast
urgent referrals have increased the pressure on already overstretched services.
Many strategies have been tried to manage the tension between the desire for early detection
of breast cancer, and avoiding unnecessary referral for normal breast sensations.
Although breast screening by self-examination or clinical examination has not been shown to
reduce breast cancer mortality in studies (10), breast awareness can be linked to early
detection that facilitates treatment and has the potential to reduce mortality (11).
Therefore, breast awareness and self-examination have become relevant parts of general breast
education promoting women's confidence to discern between normality and unusual changes
(12-17). Self-examination is not frequently taught in primary care and "there is a need to
develop more innovative strategies to promote breast health awareness and early detection of
breast cancer in women" (18). In this study, as part of a Masters in Health Policy, we are
investigating the impact of an educational video, here to be shown after a clinic
appointment, but with the potential to be distributed to general practitioners, and to
patients directly if favourably received.
Methodology
1. Patient recruitment 1.1 Initial visit to "one-stop"clinic 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.
1.2 Consent Consent will be sought by the clinician who will undertake the interviews.
2. Intervention: educational video An educational video of approximately 10 minutes about
breast pain, self-examination and breast awareness will be shown to the participant.
3. Semi-structured interview 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.
A number of pre-planned, open questions will be asked. The core questions are related to the
topic of discussion - impressions related to the intervention and subsequent effect into
their previous concerns. Further questions will evolve in response to answers given by
earlier participants. The duration of the interview will depend on the extent of the answers
and any follow-up questions that derive later from earlier answers.
Data Acquisition and analysis The video show and interview will be undertaken in a private
room after routine clinical assessment. The interviewer will be the MSc student, a
medically-qualified breast clinician with an interest in breast pain, who has read the
relevant literature. The recorded interview and notes taken by investigator during the
interview are the only data.
The analysis will run alongside data collection as an iterative process to inform further
sampling. The purpose of the analysis is to describe the participants' opinion and to develop
theoretical explanations for these. The interviews will be analysed by reading the
transcripts in detail and assigning codes to give meaning to segments of the text. Emerging
codes will be grouped into themes and discussed and then explored in subsequent interviews.
The analysis will be undertaken using the constant comparison technique of grounded theory
whereby data will be examined for differences and similarities within the themes, taking into
account the patient context. The initial codes will be modified and new codes added as the
project progresses. New data will be compared with previous interviews to identify the
similarities and differences.
Evaluation of Outcome This is a mixed methods study. As a result, we will have increased
knowledge of the perceptions of women presenting with breast pain about an educational video.
We will have some quantitative information about whether they find it informative and whether
it might lead them to avoid attending secondary care. It will guide the future management of
women with pain at the interface of primary and secondary care.
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