Clinical trial NCT03692624: Use of Heart Rate Variability (HRV) Biofeedback for Cancer Survivors
Official title: Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Cancer Survivors: Pilot Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer survivors
heart rate variability
biofeedback
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: University of South Carolina
First posted: 2018-10-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduced Pain
timeFrame: Weekly for 4 to 6 weeks
measure: Reduced Stress
timeFrame: Weekly for 4 to 6 weeks
measure: Reduced Fatigue
timeFrame: Weekly for 4 to 6 weeks
measure: Reduced Depression
timeFrame: Weekly for 4 to 6 weeks
measure: Reduced Insomnia
timeFrame: Weekly for 4 to 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Health System Cancer Institute
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Mark A O'Rourke, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Berry ME, Chapple IT, Ginsberg JP, Gleichauf KJ, Meyer JA, Nagpal ML. Non-pharmacological Intervention for Chronic Pain in Veterans: A Pilot Study of Heart Rate Variability Biofeedback. Glob Adv Health Med. 2014 Mar;3(2):28-33. doi: 10.7453/gahmj.2013.075.
citation: Burch JB, Ginsberg JP, McLain AC, Franco R, Stokes S, Susko K, Hendry W, Crowley E, Christ A, Hanna J, Anderson A, Hebert JR, O'Rourke MA. Symptom Management Among Cancer Survivors: Randomized Pilot Intervention Trial of Heart Rate Variability Biofeedback. Appl Psychophysiol Biofeedback. 2020 Jun;45(2):99-108. doi: 10.1007/s10484-020-09462-3.