Effectiveness of heart rate variability biofeedback training for improving psychological and cognitive functioning and quality of life in women with primary breast cancer

Not Applicable

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN95964384
• Lead Sponsor: Birkbeck, University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-18
• Last Update Posted: 16 October 2023
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Breast cancer survivors with a primary diagnosis of breast cancer who have finished active treatment:
1. Primary breast cancer diagnosis
2. Completed chemotherapy between 6 – 60 months ago
3. 18 – 65 years of age
4. Currently not practicing breathing exercises/techniques which involve deep or slow-paced breathing e.g., yogic breathing, Qi Gong Breathing etc on a regular basis
5. Currently experiencing sleep difficulties and hot flushes and/or night sweats (any frequency, i.e., frequent >30, or infrequent <7 per week)
6. English literate; able to complete tasks and questionnaires in English independently
7. Basic IT skills and access to laptop/desktop/tablet and smartphone

Exclusion Criteria

Breast cancer survivors with a primary diagnosis of breast cancer who has finished active treatment and who are:
1. Receiving concurrent treatment for cancer (except endocrine or biologic therapy)
2. Cardiovascular disorders that affect HRV parameters (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina, bradyarrhythmias, atrial flutter)
3. Receiving medications that affect cardiac rhythm (angiotensin-converting enzyme [ACE] inhibitors), calcium channel blockers, or beta-adrenergic inhibitors)
4. Pacemaker or defibrillator in situ
5. Had a heart transplant or by-pass surgery within 1 year
6. Any active seizure disorder or use of antiseizure or anticonvulsant medication prescribed specifically for seizure disorder
7. Pre-existing dementia prior to cancer diagnosis or other organic mental disorders
8. Moderate (without good recovery) or severe head injury or stroke in last 6 months
9. Evidence of active substance misuse or dependence
10. Any use of long-acting (extended-release) opioid medications
11. Severe and enduring major psychiatric disorder (including bipolar disorder, schizophrenia, other psychosis, and personality disorders)
12. Persisting developmental disorders including autism spectrum disorders and attention-deficit/hyperactivity disorder
13. History of brain metastases, primary brain cancer, or other neurological conditions which altered cognitive abilities
14. Moderate to severe breathing difficulties including COPD, asthma or any other pulmonary condition which may affect or prevent ability to perform paced breathing

Study & Design

• Study Type: Interventional
• Study Design: Not specified