Cancer Clinical Trial
Official title:
Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Cancer Survivors: Pilot Intervention
Verified date | March 2020 |
Source | Prisma Health-Upstate |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | February 7, 2020 |
Est. primary completion date | April 19, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Greenville Health System Cancer Institute | Greenville | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Prisma Health-Upstate | University of South Carolina |
United States,
Appelhans BM, Luecken LJ. Heart rate variability and pain: associations of two interrelated homeostatic processes. Biol Psychol. 2008 Feb;77(2):174-82. Epub 2007 Oct 12. — View Citation
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. — View Citation
de Miguel Sánchez C, Elustondo SG, Estirado A, Sánchez 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|
||
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|