N/A
N=318
The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients
Breast Cancer Female · Depressive Symptoms · Fatigue · Pain · Emotions
Bottom Line
View on ClinicalTrials.gov: NCT03377816 ↗Enrolled (actual)
318
Serious AEs
4.8%
Results posted
Oct 2023
Primary outcome: Primary: Depression Depression — 10.82; 11.57; 9.86; 11.23 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Art Therapy (Behavioral); Sham Art Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Haifa
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Depression |
10.82; 11.57; 9.86; 11.23; 11.05; 11.72 | — |
| PRIMARY Fatigue |
61.35; 63.08; 53.28; 58.99; 60.36; 63.21 | — |
| PRIMARY Pain (Impact and Interference) |
58.74; 57.4; 55.9; 56.1; 59.1; 58.0 | — |
| SECONDARY Emotional Awareness |
30.11; 30.59; 30.87; 30.9; 30.12; 28.77 | — |
| SECONDARY Emotional Expression |
3.2596; 3.185; 3.17; 3.169312169; 3.078; 3.21 | — |
| SECONDARY Acceptance of Emotions |
67.7756; 63.8561; 66.12; 68.42; 69.86; 71.29713424 | — |
| SECONDARY Inflammation |
15.78; 22.1597; 11.02; 11.84; 9.0135; 9.278 | — |
| SECONDARY Heart Rate Variability |
32.63; 37.82; 33.13; 31.89; 35.22226363; 33.58334362 | — |
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) through which an Art Therapy (AT) intervention reduces depression, pain and fatigue.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03377816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.