Status:
COMPLETED
The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients
Lead Sponsor:
University of Haifa
Collaborating Sponsors:
University of Arizona
Monash University
Conditions:
Breast Cancer Female
Depressive Symptoms
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to examine two mechanistic changes: emotion processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and cytokine expression) thr...
Detailed Description
The study is a randomized controlled study with careful controls. Our study population is comprised of 240 BC patients in palliative and curative care (comprised of 50% Jewish and 50% Arab). This popu...
Eligibility Criteria
Inclusion
- adult (\>18) females with initial or recurrent BC
- intervention can begin 3 months after finishing chemotherapy and radiotherapy (RT) and one month after surgery, up until 18 months after treatment completion.
- can complete assessments in Arabic or Hebrew
- provides informed consent.
Exclusion
- male
- lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or with a pre- cancer diagnosis of fibromyalgia or chronic fatigue syndrome
- active suicidal plan (will ensure immediate intervention);
- dementia/other disorder that would preclude informed consent or comprehension of assessments
- Individuals taking anticholinergic medications, and post myocardial infarction (6 months before recruitment) or with a pacemaker, which would render the metric of HRV invalid.
- Flare-up in systemic autoimmune disease (such as arthritis, lupus or multiple sclerosis), thyroid dysfunction that requires increases in medication
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2022
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT03377816
Start Date
June 11 2019
End Date
June 10 2022
Last Update
October 19 2023
Active Locations (1)
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1
Rabin Medical Center
Petah Tikva, Israel