NCT03377816: REPAT

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

Completed NA Results posted Last updated 19 October 2023

What this trial tests

NA trial testing Art Therapy in Breast Cancer Female in 318 participants. Completed in 10 June 2022.

Timeline

11 June 2019

Primary endpoint
10 June 2022

10 June 2022

Quick facts

Lead sponsor	University of Haifa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	318
Start date	11 June 2019
Primary completion	10 June 2022
Estimated completion	10 June 2022
Sites	1 location across Israel

Drugs / interventions tested

• Art Therapy — full drug profile →
• Sham Art Therapy

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →
• Depressive Symptoms — all drugs for Depressive Symptoms →
• Fatigue — all drugs for Fatigue →
• Pain — all drugs for Pain →

Sponsor

University of Haifa

Who can join

18 and older, female only, with Breast Cancer Female or Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Depression Depression Primary · Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)

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.

T1

Group	Value	95% CI
Art Therapy	10.82	± 6.01
Mandala Group	11.57	± 6.46

T2

Group	Value	95% CI
Art Therapy	9.86	± 6.203
Mandala Group	11.23	± 5.45

T3

Group	Value	95% CI
Art Therapy	11.05	± 5.67
Mandala Group	11.72	± 5.59

Fatigue Primary · 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 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.

T1

Group	Value	95% CI
Art Therapy	61.35	± 28.77
Mandala Group	63.08	± 29.69

T2

Group	Value	95% CI
Art Therapy	53.28	± 29.4
Mandala Group	58.99	± 24.79

T3

Group	Value	95% CI
Art Therapy	60.36	± 29.4
Mandala Group	63.21	± 28.38

Pain (Impact and Interference) Primary · Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)

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.

Pain intensity T1

Group	Value	95% CI
Art Therapy	58.74	± 12.5
Mandala Group	57.4	± 12.3

Pain intensity T2

Group	Value	95% CI
Art Therapy	55.9	± 11.9
Mandala Group	56.1	± 11.8

Pain intensity T3

Group	Value	95% CI
Art Therapy	59.1	± 11.6
Mandala Group	58.0	± 12.5

Pain interference T1

Group	Value	95% CI
Art Therapy	59.0	± 9.3
Mandala Group	59.3	± 9.4

Pain interference T2

Group	Value	95% CI
Art Therapy	56.7	± 9.43
Mandala Group	57.1	± 9.0

Pain interference T3

Group	Value	95% CI
Art Therapy	59.0	± 9.0
Mandala Group	57.7	± 9.3

Emotional Awareness Secondary · Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)

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.

T1

Group	Value	95% CI
Art Therapy	30.11	± 5.28
Mandala Group	30.59	± 6.24

T2

Group	Value	95% CI
Art Therapy	30.87	± 4.523
Mandala Group	30.9	± 5.49

T3

Group	Value	95% CI
Art Therapy	30.12	± 5.21
Mandala Group	28.77	± 4.84

Emotional Expression Secondary · Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline (T2), and 8 weeks after the intervention ends (T3)

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'').

Approach T1

Group	Value	95% CI
Art Therapy	3.2596	± 0.44
Mandala Group	3.185	± 0.54

Approach T2

Group	Value	95% CI
Art Therapy	3.17	± 0.52
Mandala Group	3.169312169	± 0.52

Approach T3

Group	Value	95% CI
Art Therapy	3.078	± 0.48
Mandala Group	3.21	± 0.52

Avoidance T1

Group	Value	95% CI
Art Therapy	1.99	± 0.56
Mandala Group	2.08	± 0.59

Avoidance T2

Group	Value	95% CI
Art Therapy	2.04	± 0.78
Mandala Group	2.18	± 0.7

Avoidance T3

Group	Value	95% CI
Art Therapy	2.21	± 0.67
Mandala Group	2.27	± 0.74

Acceptance of Emotions Secondary · Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)

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.

T1

Group	Value	95% CI
Art Therapy	67.7756	48.14273 – 87.40847
Mandala Group	63.8561	39.8156 – 87.8966

T2

Group	Value	95% CI
Art Therapy	66.12	41.852 – 90.753
Mandala Group	68.42	45.811 – 90.696

T3

Group	Value	95% CI
Art Therapy	69.86	51.84674999 – 88.72084908
Mandala Group	71.29713424	50.35255616 – 92.24171231

Inflammation Secondary · Changes will be measured from baseline (T1), after the intervention, 8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3).

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).

IL-8 T1

Group	Value	95% CI
Art Therapy	15.78	± 24.3
Mandala Group	22.1597	± 55.01

IL-8 T2

Group	Value	95% CI
Art Therapy	11.02	± 10.65
Mandala Group	11.84	± 11.9

IL-8 T3

Group	Value	95% CI
Art Therapy	9.0135	± 7.725
Mandala Group	9.278	± 9.38

il_1b_T1

Group	Value	95% CI
Art Therapy	0.42	± 1.15
Mandala Group	0.55	± 1.37

il_1b_T2

Group	Value	95% CI
Art Therapy	0.18	± 0.312
Mandala Group	0.227	± 0.5

il_1b_T3

Group	Value	95% CI
Art Therapy	0.2632	± 0.77
Mandala Group	0.234	± 0.68

il_4_T1

Group	Value	95% CI
Art Therapy	16.8	± 31.6
Mandala Group	24.33	± 50.3

il_4_T2

Group	Value	95% CI
Art Therapy	10.1	± 17.53
Mandala Group	12.7	± 23.09

Heart Rate Variability Secondary · Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3)

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.

T1

Group	Value	95% CI
Art Therapy	32.63	± 21.8
Mandala Group	37.82	± 38.8

T2

Group	Value	95% CI
Art Therapy	33.13	± 20.21
Mandala Group	31.89	± 20.7

T3

Group	Value	95% CI
Art Therapy	35.22226363	± 40.4
Mandala Group	33.58334362	± 25.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Art Therapy

Serious: 8/146 (5%)

Deaths: 1/146

Mandala Group

Serious: 6/143 (4%)

Deaths: 1/143

Serious adverse events (4 terms)

Reaction	System	Art Therapy	Mandala Group
surgery adverse event reporting	Surgical and medical procedures	—	—
prolonged hospitalization AE	General disorders	—	—
disease progression AE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Car accident	General disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Art Therapy	Mandala Group
War	Social circumstances	—	—
COVID-19	General disorders	—	—
Side effect from medication or vaccine- not study related	General disorders	—	—
Stress from family illness	Social circumstances	—	—
In mourning	Social circumstances	—	—
Injury	General disorders	—	—
Medication	General disorders	—	—

Most-reported serious reactions: surgery adverse event reporting, prolonged hospitalization AE, disease progression AE, Car accident.

Data from ClinicalTrials.gov NCT03377816 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Protocol for the REPAT study: role of emotional processing in art therapy for breast cancer palliative care patients.
   Czamanski-Cohen J, Wiley J, Weihs KL. · · 2020 · cited 11× · PMID 33444178 · DOI 10.1136/bmjopen-2020-037521