Breast Cancer FemaleREPATNCT03377816

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

A study testing Art Therapy in people with Breast Cancer Female and Depressive Symptoms, run by University of Haifa at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer Female, Depressive Symptoms, Fatigue
What is being tested?: Art Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 318 participants
Where: 1 siteIsrael
Study dates: 11 Jun 2019to 10 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

Rabin Medical Center
Petah Tikva

Other trials in Israel

About this study

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.

Read the 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.

Conditions: Breast Cancer Female, Depressive Symptoms, Fatigue, Pain, Emotions, Inflammation
Being tested: Art Therapy, Sham Art Therapy
Keywords: Emotion Processing, Art Therapy, Breast Cancer, Cholinergic anti-inflammatory pathway
Medical subject headings: Depression, Fatigue, Pain, Inflammation, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Art TherapyBehavioural
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 Art TherapyBehavioural
In a group setting participants will engage in Mandala coloring

Study groups in NCT03377816
Study group	Role	What they receive
Art Therapy	Experimental	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. Receives: Behavioral: Art Therapy
Mandala group	Sham comparator	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. Receives: Behavioral: Sham Art Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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.
Measured: 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'').
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 201910 Jun 2022

First posted19 Dec 2017
Study start11 Jun 2019
Primary completion10 Jun 2022
Study completion10 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 318 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03377816
Sponsor's protocol ID: UHaiArtBC
Other IDs: R01NR017186
Acronym: REPAT
Status last verified: Oct 2023
First submitted: 10 Dec 2017
Last updated: 19 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Czamanski-Cohen J, Wiley J, Weihs KL. Protocol for the REPAT study: role of emotional processing in art therapy for breast cancer palliative care patients. BMJ Open. 2020 Nov 19;10(11):e037521. doi: 10.1136/bmjopen-2020-037521.
PubMed 33444178
Czamanski-Cohen J, Weihs KL. The role of emotion processing in art therapy (REPAT) intervention protocol. Front Psychol. 2023 Jun 29;14:1208901. doi: 10.3389/fpsyg.2023.1208901. eCollection 2023.
PubMed 37457095

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03377816
Acronym / sponsor ID: REPAT / UHaiArtBC
Conditions: Breast Cancer Female, Depressive Symptoms, Fatigue, Pain, Emotions, Inflammation
Keywords: Emotion Processing, Art Therapy, Breast Cancer, Cholinergic anti-inflammatory pathway
Study type: Interventional
Recruitment status: Completed
Enrolment: 318 participants (actual)
Lead sponsor: University of HaifaUniversity, hospital or other
Collaborators: University of Arizona, Monash University, Rabin Medical Center, National Institute of Nursing Research (NINR)
Study start: 11 Jun 2019 (actual)
Primary completion: 10 Jun 2022 (actual)
Study completion: 10 Jun 2022 (actual)
First posted: 19 Dec 2017 (actual)
Results: Posted 19 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Art Therapy	Experimental	Behavioral: Art TherapyThe 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.
Mandala group	Sham comparator	Behavioral: Sham Art TherapyThe 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Art TherapyIn 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.	Behavioural	Art Therapy
Sham Art TherapyIn a group setting participants will engage in Mandala coloring	Behavioural	Mandala group

Primary outcome

Depression Depression
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)
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.
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)
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)
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)
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.

5 secondary outcomes

Emotional 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
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
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
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
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)

Results and safety

Results posted to the registry on 19 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Art Therapy	157	107
Mandala Group	161	108

Primary outcome: Depression Depression

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). Mean (Standard Deviation). Unit: score on a scale

Measure	Art Therapy n = 122	Mandala Group n = 118
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)

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

Primary outcome: Fatigue

Measure	Art Therapy n = 117	Mandala Group n = 120
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)

Population analysed: 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.

Primary outcome: Pain (Impact and Interference)

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). Mean (Standard Deviation). Unit: t-score

Measure	Art Therapy n = 124	Mandala Group n = 118
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)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Art Therapy	8 of 146 (5.5%)	16 of 146 (11%)	1 of 146
Mandala Group	6 of 143 (4.2%)	15 of 143 (10.5%)	1 of 143

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33444178Czamanski-Cohen J, Wiley J, Weihs KL. Protocol for the REPAT study: role of emotional processing in art therapy for breast cancer palliative care patients. BMJ Open. 2020 Nov 19;10(11):e037521. doi: 10.1136/bmjopen-2020-037521.
Background: PubMed 37457095Czamanski-Cohen J, Weihs KL. The role of emotion processing in art therapy (REPAT) intervention protocol. Front Psychol. 2023 Jun 29;14:1208901. doi: 10.3389/fpsyg.2023.1208901. eCollection 2023.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Art Therapy in people with Breast Cancer Female and Depressive Symptoms, run by University of Haifa at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression Depression (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03377816, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.