Evaluation of an Educational Intervention for Women With Breast Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Patient's perceptions on the breast-pain video
研究概览
简要总结
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.
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female patients aged between 18 years and 40 years on the day of clinic attendance (referred to one-stop breast clinic with breast pain alone)
- •Normal examination in clinic
- •No further breast investigations undertaken or required
排除标准
- •Presence of concerning features during clinical examination requiring further investigation
- •Pregnancy or lactation at the time of study diagnosis.
- •Strong family history of breast cancer
- •Recent previous imaging or clinic attendance for same symptom within last 12 months
- •Previous history of breast cancer
- •Current or previous treatment with Tamoxifen
- •Medical or psychiatric illness which, in the opinion of the assessing clinician, might impact their participation in the study
研究组 & 干预措施
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.
干预措施: Breast Pain video (Behavioral)
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.
干预措施: Semi-structure interviews (Behavioral)
结局指标
主要结局
Patient's perceptions on the breast-pain video
时间窗: 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.
次要结局
- Video's purpose evaluation(10 minutes)