- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03692624
Use of Heart Rate Variability (HRV) Biofeedback for Cancer Survivors
March 5, 2020 updated by: Prisma Health-Upstate
Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Cancer Survivors: Pilot Intervention
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.
Study Overview
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
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Health System Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Heart Rate Variability Biofeedback
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Weekly for 4 to 6 weeks
|
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 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.
|
Weekly for 4 to 6 weeks
|
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).
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Weekly for 4 to 6 weeks
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Reduced Depression
Time Frame: Weekly for 4 to 6 weeks
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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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Weekly for 4 to 6 weeks
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Reduced Insomnia
Time Frame: Weekly for 4 to 6 weeks.
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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.
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Weekly for 4 to 6 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kim DH, Kim JA, Choi YS, Kim SH, Lee JY, Kim YE. Heart rate variability and length of survival in hospice cancer patients. J Korean Med Sci. 2010 Aug;25(8):1140-5. doi: 10.3346/jkms.2010.25.8.1140. Epub 2010 Jul 21.
- Hoffmann J, Grimm W, Menz V, Wied M, Sprenger A, Arnold R, Maisch B. Prognostic value of heart rate variability analysis in patients with carcinoid syndrome. Digestion. 2001;63(1):35-42. doi: 10.1159/000051870.
- de Miguel Sanchez C, Elustondo SG, Estirado A, Sanchez FV, de la Rasilla Cooper CG, Romero AL, Otero A, Olmos LG. Palliative performance status, heart rate and respiratory rate as predictive factors of survival time in terminally ill cancer patients. J Pain Symptom Manage. 2006 Jun;31(6):485-92. doi: 10.1016/j.jpainsymman.2005.10.007.
- Mouton C, Ronson A, Razavi D, Delhaye F, Kupper N, Paesmans M, Moreau M, Nogaret JM, Hendlisz A, Gidron Y. The relationship between heart rate variability and time-course of carcinoembryonic antigen in colorectal cancer. Auton Neurosci. 2012 Jan 26;166(1-2):96-9. doi: 10.1016/j.autneu.2011.10.002. Epub 2011 Nov 9.
- Appelhans BM, Luecken LJ. Heart rate variability and pain: associations of two interrelated homeostatic processes. Biol Psychol. 2008 Feb;77(2):174-82. doi: 10.1016/j.biopsycho.2007.10.004. Epub 2007 Oct 12.
- Kapitza KP, Passie T, Bernateck M, Karst M. First non-contingent respiratory biofeedback placebo versus contingent biofeedback in patients with chronic low back pain: a randomized, controlled, double-blind trial. Appl Psychophysiol Biofeedback. 2010 Sep;35(3):207-17. doi: 10.1007/s10484-010-9130-1.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 10, 2015
Primary Completion (ACTUAL)
April 19, 2017
Study Completion (ACTUAL)
February 7, 2020
Study Registration Dates
First Submitted
September 27, 2018
First Submitted That Met QC Criteria
September 29, 2018
First Posted (ACTUAL)
October 2, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 6, 2020
Last Update Submitted That Met QC Criteria
March 5, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Pro00042898
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Information published will only be done in aggregate.
All participant information will be de-identified.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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