Empathy and Standard Diagnostic Procedures in an Outpatient Breast Clinic Might Not be Enough
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Reduction of level of anxiety compared between arm 'no intervention' and arm 'intervention' as measured via questionnaires
研究概览
简要总结
The project investigates prospectively whether anxiety in the context of breast biopsy can be reduced by the planed intervention (take-home brochure and structured and standardized information given by a psychologically trained physician who performs the biopsy).
详细描述
The fact having to have a breast biopsy taken due to suspected breast cancer is an emotionally exceptional situation not only because of the threat to be diagnosed of cancer but also because the breast is perceived as a symbol of womanhood, sexuality and motherhood.
Time, however, is scarce in a busy outpatient setting. Nevertheless doctors and nurses at the outpatient breast clinic University Hospital Basel are empathetic and try to address anxiety and give emotional support before, during, and after a necessary breast biopsy. Study findings, however suggest, that the level of anxiety, pain and discomfort associated with breast biopsies is considerable, which might not be sufficiently controlled by empathy alone but might be reduced by giving structured and standardized information.
The investigators hypothesize that the planned intervention reduces the level of anxiety in patients going for breast biopsy and thus is superior to the current standard of diagnostic procedures.
The project focuses on improving the patients' knowledge about the procedure of breast biopsy and on meeting their emotional needs to reduce anxiety related to the biopsy by giving structured and standardized information. Additionally the project investigates whether patients diagnosed with breast cancer have a higher level of anxiety than patients with benign breast disease. Furthermore the study assesses how precisely the physicians, who perform the biopsy, appraise the patients' perception of anxiety, pain and satisfaction related to the breast biopsy.
The primary objective is to demonstrate that the intervention reduces the patients' anxiety compared to the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who speak and understand German
- •women who will need a skin biopsy, core biopsy or a vacuum assisted biopsy.
排除标准
- •women receiving a fine needle Aspiration
- •women receiving an examination of a pathologic nipple secretion
- •women receiving an abscess evacuation
- •women who do not speak and understand German
研究组 & 干预措施
Intervention group
Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.
Additionally, delivery of a take-home brochure to the patients during the first visit is planned. The biopsy is explained to the patient and performed by a psychological trained physician. Patient care by a psychologically trained physician is performed in the sense that patients are informed about their biopsy result by a specifically trained physician.
干预措施: delivery of a take-home brochure (Behavioral)
Intervention group
Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.
Additionally, delivery of a take-home brochure to the patients during the first visit is planned. The biopsy is explained to the patient and performed by a psychological trained physician. Patient care by a psychologically trained physician is performed in the sense that patients are informed about their biopsy result by a specifically trained physician.
干预措施: patient care by a psychologically trained physician (Behavioral)
Intervention group
Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.
Additionally, delivery of a take-home brochure to the patients during the first visit is planned. The biopsy is explained to the patient and performed by a psychological trained physician. Patient care by a psychologically trained physician is performed in the sense that patients are informed about their biopsy result by a specifically trained physician.
干预措施: no intervention (Other)
No intervention
Patients receive the current standard of care and are asked to answer the questionnaires mentioned below.
干预措施: no intervention (Other)
结局指标
主要结局
Reduction of level of anxiety compared between arm 'no intervention' and arm 'intervention' as measured via questionnaires
时间窗: up to 19 months
次要结局
- correlation of the level of anxiety and the histological diagnosis of breast cancer measured via questionnaires(up to 19 months)
- influence of waiting time between biopsy and histological diagnosis on the level of anxiety measured via questionnaires(up to 19 months)
- patient's satisfaction with additional information concerning biopsy measured by Visual Analog Scale(up to 19 months)
- level of anxiety in the intervention group during and after biopsy measured via questionnaires(up to 19 months)
- perception of pain during and after biopsy measured via pain score(up to 19 months)
- correlation of patient's perception of pain and anxiety and physician's impression of patient's perception measured by questionnaires(up to 19 months)