Clinical trial NCT03377816: The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients
Official title: The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients: a Mechanistic Study of Art Therapy in Reducing Depression, Fatigue and Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Depressive Symptoms
Fatigue
Pain
Emotions
Inflammation
Keywords: Emotion Processing
Art Therapy
Breast Cancer
Cholinergic anti-inflammatory pathway
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: University of Arizona
name: Monash University
name: Rabin Medical Center
name: National Institute of Nursing Research (NINR)
First posted: 2017-12-19
Enrollment: 318
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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) through which an Art Therapy (AT) intervention reduces depression, pain and fatigue.

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 population will be randomized to receive a standard art therapy intervention or a comparison group. The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist The comparison group will engage in the coloring of prefabricated shapes (mandalas) and will receive Psychoeducation on topics related to coping with BC, identical to the topics of the AT group. This design will allow the study to test the mechanism of AT that is beyond the effects of time with a group, focus on a task and engagement with art materials.

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

Primary outcomes:
measure: Depression Depression
timeFrame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
measure: Fatigue
timeFrame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
measure: Pain (Impact and Interference)
timeFrame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Secondary outcomes:
measure: Emotional Awareness
timeFrame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
measure: Emotional Expression
timeFrame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline (T2), and 8 weeks after the intervention ends (T3)
measure: Acceptance of Emotions
timeFrame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
measure: Inflammation
timeFrame: Changes will be measured from baseline (T1), after the intervention, 8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3).
measure: Heart Rate Variability
timeFrame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3)
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
citation: Czamanski-Cohen J, Wiley J, Weihs KL. Protocol for the REPAT study: role of emotional processing in art therapy for breast cancer palliative care patients. BMJ Open. 2020 Nov 19;10(11):e037521. doi: 10.1136/bmjopen-2020-037521.
citation: Czamanski-Cohen J, Weihs KL. The role of emotion processing in art therapy (REPAT) intervention protocol. Front Psychol. 2023 Jun 29;14:1208901. doi: 10.3389/fpsyg.2023.1208901. eCollection 2023.