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Completed

NCT Number: NCT03692624

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greenville Health System Cancer Institute

Greenville, South Carolina, 29605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofeedback

Behavioral

Heart Rate Variability Biofeedback

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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).

  5. Reduced Insomnia

    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.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • University of South Carolina

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2020
First posted
Oct 2, 2018
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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