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

Sponsor

University of Haifa (Other)

Overall Status

Completed

CT.gov ID

NCT03377816

Collaborator

University of Arizona (Other), Monash University (Other), Rambam Health Care Campus (Other), Rabin Medical Center (Other), Ziv Medical Center (Other)

343

Enrollment

Locations

Arms

Actual Duration (Months)

114.3

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female Depressive Symptoms Fatigue Pain Emotions Inflammation	Behavioral: Art Therapy Behavioral: Sham Art Therapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

343 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The control group is designed to be similar to the intervention, participants will be engaged in interacting with art materials. Research assistants will be blinded to group allocation when collecting data.

Primary Purpose:

Supportive Care

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.

Actual Study Start Date :

Jun 11, 2019

Actual Primary Completion Date :

Jun 10, 2022

Actual Study Completion Date :

Jun 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Art Therapy 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.	Behavioral: Art Therapy 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.
Sham Comparator: Mandala group 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.	Behavioral: Sham Art Therapy In a group setting participants will engage in Mandala coloring

Arm

Intervention/Treatment

Experimental: Art Therapy

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.

Behavioral: Art Therapy

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.

Sham Comparator: Mandala group

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.

Behavioral: Sham Art Therapy

In a group setting participants will engage in Mandala coloring

Outcome Measures

Primary Outcome Measures

Depression [Changes will be measured from baseline, after the intervention and 8 weeks after the intervention ends]
The Center for Epidemiologic Studies-Depression (CES-D) scale. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Fatigue [Changes will be measured from baseline, after the intervention and 8 weeks after the intervention ends]
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 scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue in the past week.
Pain (impact and interference) [Changes will be measured from baseline, after the intervention and 8 weeks after the intervention ends]
The PROMIS Pain impact Scale measures how much pain impacted different aspects of life in the past 4 weeks. Scores range from 0-to-60, higher scores indicating higher levels of pain or its impact on functioning and the The PROMIS Pain interference Scale measures how much pain interfered with different aspects of life in the past 4 weeks. Scores range from 0-to-60, higher scores indicating higher levels of pain or its interference with functioning.

Secondary Outcome Measures

Emotional Awareness [Changes will be measured from baseline, after the intervention and 8 weeks after the intervention ends]
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 according to the degree of specificity in the terms used and the range of emotions described, higher scores indicating higher levels of awareness.
Emotional Expression [Changes will be measured from baseline, after the intervention and 8 weeks after the intervention ends]
. Emotional Approach Coping scales (e.g., emotional processing- range 4-16, emotional expression, range 4-16) higher scores indicating more expression and processing of emotions and COPE avoidance-oriented coping subscales range 10-40, higher scores indicating more denial based coping, (e.g., denial, mental disengagement), all completed with reference to women's experience of breast cancer.
Acceptance of Emotions [Changes will be measured from baseline, after the intervention and 8 weeks after the intervention ends]
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.

Other Outcome Measures

Heart rate variability [Changes will be measured from baseline, after the intervention and 8 weeks after the intervention ends]
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.
Inflammation [Changes will be measured from baseline, after the intervention and 8 weeks after the intervention ends]
We will collect 10 ccs of blood in order to measure immune dysregulation (pro-inflammatory cytokines IL-6, IL-8, IL-1β, TNF-α), anti-inflammatory (IL-4, IL-10) and regulatory cytokine (TGF-β).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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