An interventional study of Art Therapy and Sham Art Therapy in Breast Cancer Female, Depressive Symptoms and Fatigue, sponsored by University of Haifa. Completed at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by University of Haifa · Not applicable, Interventional, and Supportive care
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 318 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of Haifa is the lead sponsor of 105 studies on the registry; 27 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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
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.
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)
| Milestone | Art Therapy | Mandala Group |
|---|---|---|
| Started | 157 | 161 |
| Completed | 107 | 108 |
| Not completed | 50 | 53 |
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.
| score on a scale | Art Therapy | Mandala Group |
|---|---|---|
| T1 | 10.82 ± 6.01 | 11.57 ± 6.46 |
| T2 | 9.86 ± 6.203 | 11.23 ± 5.45 |
| T3 | 11.05 ± 5.67 | 11.72 ± 5.59 |
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.
| score on a scale | Art Therapy | Mandala Group |
|---|---|---|
| T1 | 61.35 ± 28.77 | 63.08 ± 29.69 |
| T2 | 53.28 ± 29.4 | 58.99 ± 24.79 |
| T3 | 60.36 ± 29.4 | 63.21 ± 28.38 |
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.
| t-score | Art Therapy | Mandala Group |
|---|---|---|
| Pain intensity T1 | 58.74 ± 12.5 | 57.4 ± 12.3 |
| Pain intensity T2 | 55.9 ± 11.9 | 56.1 ± 11.8 |
| Pain intensity T3 | 59.1 ± 11.6 | 58.0 ± 12.5 |
| Pain interference T1 | 59.0 ± 9.3 | 59.3 ± 9.4 |
| Pain interference T2 | 56.7 ± 9.43 | 57.1 ± 9.0 |
| Pain interference T3 | 59.0 ± 9.0 | 57.7 ± 9.3 |
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.
| score on a scale | Art Therapy | Mandala Group |
|---|---|---|
| T1 | 30.11 ± 5.28 | 30.59 ± 6.24 |
| T2 | 30.87 ± 4.523 | 30.9 ± 5.49 |
| T3 | 30.12 ± 5.21 | 28.77 ± 4.84 |
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'').
| score on a scale | Art Therapy | Mandala Group |
|---|---|---|
| Approach T1 | 3.2596 ± 0.44 | 3.185 ± 0.54 |
| Approach T2 | 3.17 ± 0.52 | 3.169312169 ± 0.52 |
| Approach T3 | 3.078 ± 0.48 | 3.21 ± 0.52 |
| Avoidance T1 | 1.99 ± 0.56 | 2.08 ± 0.59 |
| Avoidance T2 | 2.04 ± 0.78 | 2.18 ± 0.7 |
| Avoidance T3 | 2.21 ± 0.67 | 2.27 ± 0.74 |
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.
| score on a scale | Art Therapy | Mandala Group |
|---|---|---|
| T1 | 67.7756 (48.14273 to 87.40847) | 63.8561 (39.8156 to 87.8966) |
| T2 | 66.12 (41.852 to 90.753) | 68.42 (45.811 to 90.696) |
| T3 | 69.86 (51.84674999 to 88.72084908) | 71.29713424 (50.35255616 to 92.24171231) |
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).
| pcg/ml | Art Therapy | Mandala Group |
|---|---|---|
| IL-8 T1 | 15.78 ± 24.3 | 22.1597 ± 55.01 |
| IL-8 T2 | 11.02 ± 10.65 | 11.84 ± 11.9 |
| IL-8 T3 | 9.0135 ± 7.725 | 9.278 ± 9.38 |
| il_1b_T1 | 0.42 ± 1.15 | 0.55 ± 1.37 |
| il_1b_T2 | 0.18 ± 0.312 | 0.227 ± 0.5 |
| il_1b_T3 | 0.2632 ± 0.77 | 0.234 ± 0.68 |
| il_4_T1 | 16.8 ± 31.6 | 24.33 ± 50.3 |
| il_4_T2 | 10.1 ± 17.53 | 12.7 ± 23.09 |
| il_4_T3 | 11.2 ± 35.7 | 14.58 ± 40.49 |
| il_6_T1 | 1.4 ± 3.1 | 1.52 ± 3.1 |
| il_6_T2 | 0.75 ± 1.58 | 0.9 ± 1.97 |
| il_6_T3 | 0.68 ± 1.62 | 1.48 ± 4.11 |
| tnfa_T1 | 10.85 ± 15.36 | 14.27 ± 23.07 |
| tnfa_T2 | 8.007 ± 4.8 | 9.64 ± 11.98 |
| tnfa_T3 | 7.56 ± 10.68 | 10.04 ± 14.49 |
| il_10_T1 | 0.43 ± 1.3 | 0.65 ± 2.04 |
| il_10_T2 | 0.19 ± 0.43 | 0.53 ± 1.44 |
| il_10_T3 | 0.34 ± 0.99 | 0.718 ± 2.36 |
| tgf_b1_T1 | 51085 ± 32095 | 51016 ± 31641 |
| tgf_b1_T2 | 48885 ± 22571 | 47819 ± 25255 |
| tgf_b1_T3 | 51447 ± 34759 | 48178 ± 23994 |
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.
| miliseconds | Art Therapy | Mandala Group |
|---|---|---|
| T1 | 32.63 ± 21.8 | 37.82 ± 38.8 |
| T2 | 33.13 ± 20.21 | 31.89 ± 20.7 |
| T3 | 35.22226363 ± 40.4 | 33.58334362 ± 25.6 |
Collected over Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Art Therapy | 1/146 (0.7%) | 8/146 (5.5%) | 16/146 (11%) |
| Mandala Group | 1/143 (0.7%) | 6/143 (4.2%) | 15/143 (10.5%) |
| Event | Art Therapy | Mandala Group |
|---|---|---|
| surgery adverse event reportingSurgical and medical procedures | 4/146 | 4/143 |
| prolonged hospitalization AEGeneral disorders | 2/146 | 1/143 |
| disease progression AENeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/146 | 1/143 |
| Car accidentGeneral disorders | 1/146 | 0/143 |
| Event | Art Therapy | Mandala Group |
|---|---|---|
| WarSocial circumstances | 6/146 | 11/143 |
| COVID-19General disorders | 3/146 | 3/143 |
| Side effect from medication or vaccine- not study relatedGeneral disorders | 2/146 | 0/143 |
| Stress from family illnessSocial circumstances | 2/146 | 0/143 |
| In mourningSocial circumstances | 1/146 | 1/143 |
| InjuryGeneral disorders | 1/146 | 0/143 |
| MedicationGeneral disorders | 1/146 | 0/143 |
318 BC survivors over the age of 18 signed informed consent and were randomized to one of two groups, 289 completed baseline measurements.
| Age, Customized(Participants) | Art Therapy | Mandala Group | Total |
|---|---|---|---|
| Age — 26-35 | 9 | 5 | 14 |
| Age — 36-45 | 31 | 23 | 54 |
| Age — 46-70 | 80 | 85 | 165 |
| Age — 70+ | 9 | 9 | 18 |
| Age — missing | 17 | 21 | 38 |
| Sex: Female, Male(Participants) | Art Therapy | Mandala Group | Total |
|---|---|---|---|
| Female | 146 | 143 | 289 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Art Therapy | Mandala Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 146 | 143 | 289 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Art Therapy | Mandala Group | Total |
|---|---|---|---|
| Israel | 146 | 143 | 289 |
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