Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Training intervention:
The intervention involves a 4-week Heart Rate Variability biofeedback (HRVB) training which involves paced breathing. Numerous studies across health and clinical populations ha
HeartMath Inc.). The training protocol involves daily breathing training, 5 days per week, starting with 10 minutes twice daily training and ending with 20 minutes twice daily training by week 4 (trai
Sponsors
Birkbeck, University of London
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessed at three timepoints - pre-training [baseline], post-training, and at 6-month follow-up: 1. Resting heart rate and heart rate variability assessed using a portable pulse monitor 2. Cognitive flexibility assessed using computerised Cued Task-Switching task 3. Psychological stress reactivity assessed by heart rate and heart rate variability measurements and subjective mood ratings during an Internet-based Trier Social Stress Test (iTSST) 4. Perceived quality of sleep assessed using Pittsburgh Sleep Quality Index (PSQI) and qualitative interview measures 5. Self-reported frequency of hot flushes and night sweats and associated problem rating assessed using the Hot Flush Rating Scale (HFRS) and qualitative interview measures 6. Perceived emotion regulation assessed using the Emotion Regulation Questionnaire (ERQ) and qualitative interview measures | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed at three timepoints - pre-training [baseline], post-training, and at 6-month follow-up. 1. Perceived cognitive functioning measured using the Functional Assessment of Cancer Therapy-Cognitive Scale (FACT-Cog, version 3) and qualitative interview measures 2. Perceived stress level assessed using the Perceived Stress Scale (PSS) 3. Anxiety and depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS). 4. Perceived cancer-specific distress assessed using the Revised Impact of Events Scale for cancer care (IES-R) 5. Perceived fatigue symptomatology and its impact on daily functioning assessed using the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F, version 4) 6. Subjective measure of health morbidity and mortality risk assessed using Charlson Comorbidity Index (CCI; modified version) 7. Perceived quality of life, emotional, cognitive, and daily functioning and coping with common difficulties including sleep difficulties and hot flushes assessed using qualitative semi-structured interviews, analysed using a Framework approach | — |
Countries
England, United Kingdom
Outcome results
None listed