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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03377816
Acronym
REPAT
Enrollment
318
Registered
2017-12-19
Start date
2019-06-11
Completion date
2022-06-10
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female, Depressive Symptoms, Emotions, Fatigue, Inflammation, Pain

Keywords

Emotion Processing, Art Therapy, Breast Cancer, Cholinergic anti-inflammatory pathway

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.

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.

Interventions

BEHAVIORALArt 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.

BEHAVIORALSham Art Therapy

In a group setting participants will engage in Mandala coloring

Sponsors

University of Arizona
CollaboratorOTHER
Monash University
CollaboratorOTHER
Rabin Medical Center
CollaboratorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Haifa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depression DepressionChanges 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.
FatigueChanges 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.
Pain (Impact and Interference)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.

Secondary

MeasureTime frameDescription
InflammationChanges 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).
Emotional AwarenessChanges 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.
Heart Rate VariabilityChanges 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.
Emotional ExpressionChanges 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'').
Acceptance of EmotionsChanges 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.

Countries

Israel

Participant flow

Participants by arm

ArmCount
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. 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.
146
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. Sham Art Therapy: In a group setting participants will engage in Mandala coloring
143
Total289

Baseline characteristics

CharacteristicArt TherapyMandala GroupTotal
Age, Customized
Age
26-35
9 Participants5 Participants14 Participants
Age, Customized
Age
36-45
31 Participants23 Participants54 Participants
Age, Customized
Age
46-70
80 Participants85 Participants165 Participants
Age, Customized
Age
70+
9 Participants9 Participants18 Participants
Age, Customized
Age
missing
17 Participants21 Participants38 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
146 Participants143 Participants289 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Region of Enrollment
Israel
146 participants143 participants289 participants
Sex: Female, Male
Female
146 Participants143 Participants289 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1461 / 143
other
Total, other adverse events
16 / 14615 / 143
serious
Total, serious adverse events
8 / 1466 / 143

Outcome results

Primary

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)

Population: The posted data are raw, before multiple imputations.

ArmMeasureGroupValue (MEAN)Dispersion
Art TherapyDepression DepressionT29.86 score on a scaleStandard Deviation 6.203
Art TherapyDepression DepressionT311.05 score on a scaleStandard Deviation 5.67
Art TherapyDepression DepressionT110.82 score on a scaleStandard Deviation 6.01
Mandala GroupDepression DepressionT211.23 score on a scaleStandard Deviation 5.45
Mandala GroupDepression DepressionT111.57 score on a scaleStandard Deviation 6.46
Mandala GroupDepression DepressionT311.72 score on a scaleStandard Deviation 5.59
Primary

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)

Population: We utilized full maximum likelihood, and the numbers presented here are raw data in which if an individual missed one item from the scale, it was marked as missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Art TherapyFatigueT161.35 score on a scaleStandard Deviation 28.77
Art TherapyFatigueT253.28 score on a scaleStandard Deviation 29.4
Art TherapyFatigueT360.36 score on a scaleStandard Deviation 29.4
Mandala GroupFatigueT163.08 score on a scaleStandard Deviation 29.69
Mandala GroupFatigueT258.99 score on a scaleStandard Deviation 24.79
Mandala GroupFatigueT363.21 score on a scaleStandard Deviation 28.38
Primary

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)

Population: The overall number of participants analyzed reflects the number of participants at T1. We used the maximum likelihood analyses, thus each row reflects the actual number of participants who had full data and the respective means and standard deviations.

ArmMeasureGroupValue (MEAN)Dispersion
Art TherapyPain (Impact and Interference)Pain intensity T359.1 t-scoreStandard Deviation 11.6
Art TherapyPain (Impact and Interference)Pain interference T256.7 t-scoreStandard Deviation 9.43
Art TherapyPain (Impact and Interference)Pain interference T159.0 t-scoreStandard Deviation 9.3
Art TherapyPain (Impact and Interference)Pain intensity T255.9 t-scoreStandard Deviation 11.9
Art TherapyPain (Impact and Interference)Pain interference T359.0 t-scoreStandard Deviation 9
Art TherapyPain (Impact and Interference)Pain intensity T158.74 t-scoreStandard Deviation 12.5
Mandala GroupPain (Impact and Interference)Pain interference T357.7 t-scoreStandard Deviation 9.3
Mandala GroupPain (Impact and Interference)Pain intensity T157.4 t-scoreStandard Deviation 12.3
Mandala GroupPain (Impact and Interference)Pain intensity T256.1 t-scoreStandard Deviation 11.8
Mandala GroupPain (Impact and Interference)Pain intensity T358.0 t-scoreStandard Deviation 12.5
Mandala GroupPain (Impact and Interference)Pain interference T257.1 t-scoreStandard Deviation 9
Mandala GroupPain (Impact and Interference)Pain interference T159.3 t-scoreStandard Deviation 9.4
Secondary

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)

Population: We conducted maximum likelihood analyses and the numbers here are raw scores, in which if a participant skipped one item the entire questionnaire was marked missing.

ArmMeasureGroupValue (MEAN)
Art TherapyAcceptance of EmotionsT167.7756 score on a scale
Art TherapyAcceptance of EmotionsT266.12 score on a scale
Art TherapyAcceptance of EmotionsT369.86 score on a scale
Mandala GroupAcceptance of EmotionsT163.8561 score on a scale
Mandala GroupAcceptance of EmotionsT268.42 score on a scale
Mandala GroupAcceptance of EmotionsT371.29713424 score on a scale
Secondary

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)

Population: We used maximum likelihood for analyses. The numbers here reflect raw data, where if one question was not answered, the whole questionnaire is marked as missing data.

ArmMeasureGroupValue (MEAN)Dispersion
Art TherapyEmotional AwarenessT330.12 score on a scaleStandard Deviation 5.21
Art TherapyEmotional AwarenessT130.11 score on a scaleStandard Deviation 5.28
Art TherapyEmotional AwarenessT230.87 score on a scaleStandard Deviation 4.523
Mandala GroupEmotional AwarenessT230.9 score on a scaleStandard Deviation 5.49
Mandala GroupEmotional AwarenessT328.77 score on a scaleStandard Deviation 4.84
Mandala GroupEmotional AwarenessT130.59 score on a scaleStandard Deviation 6.24
Secondary

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)

Population: We utilized maximum likelihood, and here are presented raw data, in which if a participant missed one question, the data was marked as missing.

ArmMeasureGroupValue (MEAN)Dispersion
Art TherapyEmotional ExpressionApproach T33.078 score on a scaleStandard Deviation 0.48
Art TherapyEmotional ExpressionAvoidance T11.99 score on a scaleStandard Deviation 0.56
Art TherapyEmotional ExpressionAvoidance T32.21 score on a scaleStandard Deviation 0.67
Art TherapyEmotional ExpressionApproach T13.2596 score on a scaleStandard Deviation 0.44
Art TherapyEmotional ExpressionApproach T23.17 score on a scaleStandard Deviation 0.52
Art TherapyEmotional ExpressionAvoidance T22.04 score on a scaleStandard Deviation 0.78
Mandala GroupEmotional ExpressionAvoidance T32.27 score on a scaleStandard Deviation 0.74
Mandala GroupEmotional ExpressionApproach T33.21 score on a scaleStandard Deviation 0.52
Mandala GroupEmotional ExpressionApproach T23.169312169 score on a scaleStandard Deviation 0.52
Mandala GroupEmotional ExpressionAvoidance T12.08 score on a scaleStandard Deviation 0.59
Mandala GroupEmotional ExpressionAvoidance T22.18 score on a scaleStandard Deviation 0.7
Mandala GroupEmotional ExpressionApproach T13.185 score on a scaleStandard Deviation 0.54
Secondary

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)

Population: Each row represents the actual number of participants we were able to collect EKG and obtain a good signal, and data was not discarded because of too much noise, or reporting drinking coffee before the measurement,

ArmMeasureGroupValue (MEAN)Dispersion
Art TherapyHeart Rate VariabilityT132.63 milisecondsStandard Deviation 21.8
Art TherapyHeart Rate VariabilityT233.13 milisecondsStandard Deviation 20.21
Art TherapyHeart Rate VariabilityT335.22226363 milisecondsStandard Deviation 40.4
Mandala GroupHeart Rate VariabilityT137.82 milisecondsStandard Deviation 38.8
Mandala GroupHeart Rate VariabilityT231.89 milisecondsStandard Deviation 20.7
Mandala GroupHeart Rate VariabilityT333.58334362 milisecondsStandard Deviation 25.6
Secondary

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).

Population: Number in each row reflect the number of results obtain for each cytokine at each time point. The overall number analyzed reflects the largest number of individuals that provided blood that was able to produce a quantification of at least one cytokine.

ArmMeasureGroupValue (MEAN)Dispersion
Art TherapyInflammationil_4_T311.2 pcg/mlStandard Deviation 35.7
Art TherapyInflammationIL-8 T211.02 pcg/mlStandard Deviation 10.65
Art TherapyInflammationil_6_T11.4 pcg/mlStandard Deviation 3.1
Art TherapyInflammationil_1b_T20.18 pcg/mlStandard Deviation 0.312
Art TherapyInflammationil_6_T20.75 pcg/mlStandard Deviation 1.58
Art TherapyInflammationtnfa_T28.007 pcg/mlStandard Deviation 4.8
Art TherapyInflammationil_6_T30.68 pcg/mlStandard Deviation 1.62
Art TherapyInflammationil_1b_T30.2632 pcg/mlStandard Deviation 0.77
Art TherapyInflammationtnfa_T110.85 pcg/mlStandard Deviation 15.36
Art TherapyInflammationil_10_T10.43 pcg/mlStandard Deviation 1.3
Art TherapyInflammationIL-8 T39.0135 pcg/mlStandard Deviation 7.725
Art TherapyInflammationil_10_T20.19 pcg/mlStandard Deviation 0.43
Art TherapyInflammationil_4_T116.8 pcg/mlStandard Deviation 31.6
Art TherapyInflammationil_10_T30.34 pcg/mlStandard Deviation 0.99
Art TherapyInflammationtnfa_T37.56 pcg/mlStandard Deviation 10.68
Art TherapyInflammationtgf_b1_T151085 pcg/mlStandard Deviation 32095
Art TherapyInflammationil_4_T210.1 pcg/mlStandard Deviation 17.53
Art TherapyInflammationtgf_b1_T248885 pcg/mlStandard Deviation 22571
Art TherapyInflammationil_1b_T10.42 pcg/mlStandard Deviation 1.15
Art TherapyInflammationtgf_b1_T351447 pcg/mlStandard Deviation 34759
Art TherapyInflammationIL-8 T115.78 pcg/mlStandard Deviation 24.3
Mandala GroupInflammationtgf_b1_T348178 pcg/mlStandard Deviation 23994
Mandala GroupInflammationtnfa_T114.27 pcg/mlStandard Deviation 23.07
Mandala GroupInflammationtnfa_T29.64 pcg/mlStandard Deviation 11.98
Mandala GroupInflammationtnfa_T310.04 pcg/mlStandard Deviation 14.49
Mandala GroupInflammationIL-8 T122.1597 pcg/mlStandard Deviation 55.01
Mandala GroupInflammationIL-8 T211.84 pcg/mlStandard Deviation 11.9
Mandala GroupInflammationIL-8 T39.278 pcg/mlStandard Deviation 9.38
Mandala GroupInflammationil_1b_T10.55 pcg/mlStandard Deviation 1.37
Mandala GroupInflammationil_1b_T20.227 pcg/mlStandard Deviation 0.5
Mandala GroupInflammationil_1b_T30.234 pcg/mlStandard Deviation 0.68
Mandala GroupInflammationil_4_T124.33 pcg/mlStandard Deviation 50.3
Mandala GroupInflammationil_4_T212.7 pcg/mlStandard Deviation 23.09
Mandala GroupInflammationil_4_T314.58 pcg/mlStandard Deviation 40.49
Mandala GroupInflammationil_6_T11.52 pcg/mlStandard Deviation 3.1
Mandala GroupInflammationil_6_T20.9 pcg/mlStandard Deviation 1.97
Mandala GroupInflammationil_6_T31.48 pcg/mlStandard Deviation 4.11
Mandala GroupInflammationil_10_T10.65 pcg/mlStandard Deviation 2.04
Mandala GroupInflammationil_10_T20.53 pcg/mlStandard Deviation 1.44
Mandala GroupInflammationil_10_T30.718 pcg/mlStandard Deviation 2.36
Mandala GroupInflammationtgf_b1_T151016 pcg/mlStandard Deviation 31641
Mandala GroupInflammationtgf_b1_T247819 pcg/mlStandard Deviation 25255

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026