Use of Heart Rate Variability (HRV) Biofeedback for Cancer Survivors
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Greenville Health System
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信息的提供 (责任方):
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 27, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | May 10, 2015 | ||
| 预计主要完成日期 | April 19, 2017 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Reduced Pain[ Time Frame: Weekly for 4 to 6 weeks ] Participants will attend an HRV-B training session once a week for up to 6 weeks. They will complete a questionnaire which includes a symptom cluster assessment related to pain using the Brief Pain Inventory (BPI). Reduced Stress[ Time Frame: Weekly for 4 to 6 weeks ] Participants will attend an HRV-B training session once a week for up to 6 weeks. They will complete a questionnaire which includes a symptom cluster inventory related to distress using the Perceived Stress Scale (PSS). Reduced Fatigue[ Time Frame: Weekly for 4 to 6 weeks ] Participants will attend an HRV-B training session once a week for up to 6 weeks. They will complete a questionnaire which includes a symptom cluster inventory related to fatigue using the Multi-Dimensional Fatigue Inventory (MFI). Reduced Depression[ Time Frame: Weekly for 4 to 6 weeks ] Participants will attend an HRV-B training session once a week for up to 6 weeks. They will complete a questionnaire which includes a symptom cluster inventory related to depression using the Beck Depression Inventory II (BDI-II). |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Use of Heart Rate Variability (HRV) Biofeedback for Cancer Survivors | ||
| 正式标题 ICMJE | Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Cancer Survivors: Pilot Intervention | ||
| 简要概况 | Heart rate variability biofeedback (HRV-B) is a complementary, non-pharmacologic therapy that is being tested to see if it can help cancer survivors reduce their symptoms of pain, stress, insomnia, fatigue, or depression. HRV-B is an interactive procedure in which participants relax and breathe regularly while watching the a computer screen. The computer screen provides feedback that helps people increase their heart rate variability. |
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| 详细说明 | Cancer survivors often suffer from prolonged and persistent symptom clusters that can include: pain, stress, depression, fatigue, and insomnia; symptoms that have each been associated with inflammation. The number of cancer survivors in the United States is expected to triple by the year 2030. Thus, there is a compelling need to develop and refine effective methods to promote high quality cancer survivorship. Dysregulation of autonomic function is a key pathophysiological 'common denominator' whereby many cancer-related symptoms likely converge. Heart rate variability (HRV) is a valid, noninvasive measure of autonomic function with established pathological and psychophysiological attributes. Reduced HRV is a known mortality risk factor, and about 80% of advanced cancer patients exhibit autonomic dysregulation. Cancer survivors with reduced HRV have increased mortality risk relative to those with normal HRV. HRV biofeedback (HRV-B) is an interactive procedure whereby patients learn to increase HRV and restore autonomic balance. HRV coherence refers to a state of optimum HRV rhythm that produces physiological entrainment of HRV, respiration, and the baroreflex. With HRV coherence, consecutive inter-beat intervals cycle from maximum to minimum and back to maximum over a period of about 10 seconds, which is associated with increased parasympathetic and decreased sympathetic tone, and a heightened state of well-being including improved affect, cognition, and executive function. Previous research suggests that HRV-B interventions may be useful for reducing symptoms of: chronic pain, anxiety, depression, post-traumatic stress disorder (PTSD), heart disease, and insomnia. HRV-B thus represents a promising complementary, nonpharmacological therapy that merits examination for relief of chronic pain and related symptoms among cancer survivors. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: Cancer patients will be recruited from the Cancer Institute at Greenville Health System. Random assignment to the HRV-B or control group will occur after baseline assessment. During the baseline assessment, participants will be asked to fill out a questionnaire, including information about symptoms and feelings. Participant heart rate (pulse) and breathing will be measured for 15 minutes. Baseline heart rate will be measured with a sensor loosely attached to the wrist. Breathing will be monitored by another sensor attached around the abdomen by a belt. Each weekly HRV-B training session will last 30-45 minutes. In each session, heart rate and breathing will be monitored while the participant is viewing pleasant images on a computer screen. An Intervention professional will be present throughout the session. While viewing the images, the participant will be coached on how to control their pulse. 盲法: Interventional 盲法描述: 主要目的: Supportive Care |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Active, not recruiting | ||
| 预计入组 ICMJE |
34 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 1, 2019 | ||
| 预计主要完成日期 | April 19, 2017 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - histopathologically confirmed diagnosis of cancer having completed radiation or chemotherapy - 18 years of age or older - English literate Exclusion Criteria: - patients receiving concurrent treatment for cancer except hormonal or biologic therapy - patients with cardiovascular disorders that affect HRV parameters (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina) - patients receiving medications that affect cardiac rhythm (angiotensin converting enzyme, calcium channel, or beta-adrenergic inhibitors) - patients with a pacemaker or defibrillator - patients who have had a heart transplant or by-pass surgery within 1 year - patients with any active seizure disorder or use of antiseizure or anticonvulsant medication prescribed specifically for seizure disorder - patients with a pre-existing dementia prior to cancer diagnosis - patients with a moderate (without good recovery) or severe head injury or stroke in last 6 months - patients with evidence of active substance abuse or dependence - patients with a history of any major psychiatric disorder - patients with a history of brain metastases, primary brain cancer, or altered cognitive abilities - patients with any use of long acting (extended release) opioid medications | ||
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Greenville Health System | ||
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| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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