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

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Collaborators:

Information provided by (Responsible Party):

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Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

May 10, 2015

Estimated Primary Completion Date

April 19, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^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).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Cancer Survivors: Pilot Intervention

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Interventional
Masking Description:
Primary Purpose: Supportive Care

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Biofeedback
Heart Rate Variability Biofeedback

Study Arms

Experimental: Intervention Group
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.
No Intervention: Control Group
To control for the laboratory environment or other potential placebo effects, a control group will receive their usual follow-up care for their cancer diagnosis and will complete baseline and post-baseline outcome assessments without any HRV-B training.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 1, 2019

Estimated Primary Completion Date

April 19, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Greenville Health System

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Mark A O'Rourke, MD Greenville Health System

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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