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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
318
In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
In a group setting participants will engage in Mandala coloring
Rabin Medical Center
Petah Tikva, Israel
Depression Depression
The Center for Epidemiologic Studies-Depression (CES-D) 10-item scale. The possible range of scores is zero to 50, with the higher scores indicating the presence of more symptomatology.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Fatigue
Fatigue will be assessed using the Fatigue Symptom Inventory (FSI), a 14-item self-report measure designed to assess the severity of fatigue on an 11-point scale (0=not at all fatigued; 10=as fatigued as I could be) that assesses most, least, and average fatigue in the past week. A global score can be obtained summing items 1-13, resulting in a scale with a range between 0-130. Higher results represent higher levels of global fatigue.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Pain (Impact and Interference)
The PROMIS Pain impact Scale measures how much pain impacted different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or its impact on functioning and the PROMIS Pain Interference Scale measures how much pain interfered with different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or interference with functioning. Our data indicates t-scores calculated so that 50 indicates the population (cancer patient) mean with a standard deviation of 10.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Emotional Awareness
The Levels of Emotional Awareness Scale is a written performance index of ability to express emotion in a differentiated and complex way. Subjects write about their anticipated feelings and those of another person in response to 10 short vignettes. Responses are scored on a 1 - 4 range and summed up to create a range of 0-50 according to the degree of specificity in the terms used and the range of emotions described, higher scores indicating higher levels of awareness.
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Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Emotional Expression
This is a 36-item scale in which participants respond on a Likert scale from 1 (I don't do this at all) to 4 (I do this a lot) regarding how they coped with breast cancer experiences in the past four weeks. Two subscales are created from means of items: Approach Coping composite (24 items), and Avoidance composite (12 items) each with a range from 1-4 . Higher scores indicate more approach-oriented or avoidance-oriented coping. Participants rated items on a response scale of 1 (''I don't do this at all'') to 4 (''I do this a lot'').
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline (T2), and 8 weeks after the intervention ends (T3)
Acceptance of Emotions
The Acceptance of Emotions Scale assesses the extent to which subjects are accepting and nurturing toward their feelings, ranging 0-100, higher scores indicate higher acceptance of emotion.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Inflammation
We collected 10 ccs of blood in order to measure immune regulation (pro-inflammatory cytokines IL-6, IL-8, IL-1β, TNF-α), anti-inflammatory (IL-4, IL-10) and regulatory cytokines (TGF-β).
Time frame: Changes will be measured from baseline (T1), after the intervention, 8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3).
Heart Rate Variability
20 minutes of resting ECG data will be recorded. The participants will be given instructions not to drink coffee or smoke for 3 hours before the lab visit as well as to sit quietly without talking or moving during the ECG recording. These are physiological data without a specific range, however in our study, for example, at T1 in the art therapy group the measurements ranged from 7.56 to 113.28 miliseconds.
Time frame: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3)