ISRCTN12824632已完成3 期
A multicentre randomised controlled trial of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer
niversity of Southampton0 个研究点目标入组 130 人开始时间: 2017年1月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29739384 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32458473/ (added 20/05/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Randomised controlled trial:
- •1. Women with primary breast cancer or DCIS
- •2. Women who have completed primary surgery radiotherapy and chemotherapy (may still be receiving adjuvant endocrine therapy or Herceptin)
- •3. Aged 16 years and over
- •4. Experiencing seven or more problematic HFNS/week, with an overall problem rating score of 4/10 or more
- •5. Ability and willingness to attend group sessions
- •6. Written informed consent
- •Process evaluation:
- •1. BCNs delivering the intervention (2 from each centre)
- •2. Purposively selected participants from the intervention arm who have consented to be interviewed (2 from each centre)
- •3. Managers and medical staff from participating centres, who are responsible for breast care services (1 manager and 1 member of the medical team from each centre)
排除标准
- •Randomised controlled trial:
- •1. Benign breast disease
- •2. Metastatic disease
- •3. Current use of other therapies to help with HFNS, e.g. acupuncture, hypnosis and mindfulness
- •Process evaluation:
- •Participants who have not indicated that they are happy to be interviewed on the Consent Form.
研究者
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