Greenville Health System Cancer Institute
Greenville, South Carolina, 29605, United States
NCT Number: NCT03692624
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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Notify MeCancer 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Heart Rate Variability Biofeedback
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).
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 SUSCRO Distress Inventory which includes a symptom cluster inventory related to distress. The inventory includes 12 questions which are self-rated from 0 (not at all) to 4 (most of the time). Lower scores indicate less distress and higher scores indicate severe distress.
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).
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).
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 the Insomnia Symptom Questionnaire (ISQ) which includes a symptom cluster inventory related to sleep patterns. The inventory includes 13 self-rated questions. Questions 1, 2 or 5 are used to determine the presence, frequency and duration of sleep symptom criteria. Questions 6 through 13 are used to identify significant daytime consequences of sleep disturbance.
Prisma Health-Upstate
Other
Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Cancer Survivors: Pilot Intervention
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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