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

NCT03692624 | Completed

• 1 other identifier: Pro00042898
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

cancer survivors; heart rate variability; biofeedback

Outcome Measures

Primary Outcomes (5)

• Reduced Pain

  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).

  Weekly for 4 to 6 weeks

• Reduced Stress

  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

  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).

  Weekly for 4 to 6 weeks

• Reduced Depression

  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).

  Weekly for 4 to 6 weeks

• Reduced Insomnia

  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.

  Weekly for 4 to 6 weeks.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Biofeedback

Control Group

NO INTERVENTION

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.

Interventions

Biofeedback BEHAVIORAL

Heart Rate Variability Biofeedback

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histopathologically confirmed diagnosis of cancer having completed radiation or chemotherapy
• years of age or older
• English literate

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• University of South Carolina: collaborator

Study Sites (1)

Greenville Health System Cancer Institute

Greenville, South Carolina, 29605, United States

Location

Related Publications (8)

• 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.

  PMID: 20676323 BACKGROUND

• 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.

  PMID: 11173898 BACKGROUND

• 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.

  PMID: 16793488 BACKGROUND

• 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.

  PMID: 22070982 BACKGROUND

• 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.

  PMID: 18023960 BACKGROUND

• 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.

  PMID: 20237953 BACKGROUND

• 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.

  PMID: 24808979 BACKGROUND

• 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.

  PMID: 32358782 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Mark A O'Rourke, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 2, 2018
• Study Start: May 10, 2015
• Primary Completion: April 19, 2017
• Study Completion: February 7, 2020
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)