The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients (REPAT)

University of Haifa

Status: Completed

Conditions: Depressive Symptoms; Inflammation; Breast Cancer Female; Emotions; Fatigue; Pain

Treatments: Behavioral: Art Therapy; Behavioral: Sham Art Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03377816

R01NR017186 (U.S. NIH Grant/Contract)

UHaiArtBC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 318 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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318 participants in 2 patient groups

Art Therapy

Experimental group

Description:

The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.

Treatment:

Behavioral: Art Therapy

Mandala group

Sham Comparator group

Description:

The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.

Treatment:

Behavioral: Sham Art Therapy