Use of Heart Rate Variability (HRV) Biofeedback for Cancer Survivors

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Biofeedback

• Registration Number: NCT03692624
• Lead Sponsor: Prisma Health-Upstate

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.

Study Timeline

• Study Start: 2015-05-10
• Primary Completion: 2017-04-19
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-29
• Study First Posted: 2018-10-02
• Study Completion: 2020-02-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Biofeedback	Biofeedback. Participants receiving the HRV-B intervention will complete a baseline assessment, a minimum of 4 weeks and up to 6 weekly training sessions (until the criterion of HRV coherence is met), and a final appointment (3-7 days later) where post-training HRV and symptom inventories will be recorded.

Primary Outcome Measures

Name	Time	Method
Reduced Pain	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	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.
Reduced Fatigue	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	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).
Reduced Insomnia	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.

Trial Locations

Locations (1)

Greenville Health System Cancer Institute; 🇺🇸 Greenville, South Carolina, United States