ISRCTN95964384进行中（未招募）未知
A randomised control trial investigating the efficacy of heart rate variability biofeedback training for improving psychological and cognitive functioning and quality of life in women with primary breast cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Breast cancer survivors with a primary diagnosis of breast cancer who have finished active treatment:
- •1. Primary breast cancer diagnosis
- •2. Completed chemotherapy between 6 – 60 months ago
- •3. 18 – 65 years of age
- •4. Currently not practicing breathing exercises/techniques which involve deep or slow-paced breathing e.g., yogic breathing, Qi Gong Breathing etc on a regular basis
- •5. Currently experiencing sleep difficulties and hot flushes and/or night sweats (any frequency, i.e., frequent >30, or infrequent <7 per week)
- •6. English literate; able to complete tasks and questionnaires in English independently
- •7. Basic IT skills and access to laptop/desktop/tablet and smartphone
排除标准
- •Breast cancer survivors with a primary diagnosis of breast cancer who has finished active treatment and who are:
- •1. Receiving concurrent treatment for cancer (except endocrine or biologic therapy)
- •2. Cardiovascular disorders that affect HRV parameters (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina, bradyarrhythmias, atrial flutter)
- •3. Receiving medications that affect cardiac rhythm (angiotensin-converting enzyme [ACE] inhibitors), calcium channel blockers, or beta-adrenergic inhibitors)
- •4. Pacemaker or defibrillator in situ
- •5. Had a heart transplant or by-pass surgery within 1 year
- •6. Any active seizure disorder or use of antiseizure or anticonvulsant medication prescribed specifically for seizure disorder
- •7. Pre-existing dementia prior to cancer diagnosis or other organic mental disorders
- •8. Moderate (without good recovery) or severe head injury or stroke in last 6 months
- •9. Evidence of active substance misuse or dependence
- •10. Any use of long-acting (extended-release) opioid medications
- •11. Severe and enduring major psychiatric disorder (including bipolar disorder, schizophrenia, other psychosis, and personality disorders)
- •12. Persisting developmental disorders including autism spectrum disorders and attention-deficit/hyperactivity disorder
- •13. History of brain metastases, primary brain cancer, or other neurological conditions which altered cognitive abilities
- •14. Moderate to severe breathing difficulties including COPD, asthma or any other pulmonary condition which may affect or prevent ability to perform paced breathing
研究者
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