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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR017186 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Arizona | OTHER |
| Monash University | OTHER |
| Rabin Medical Center | OTHER |
| National Institute of Nursing Research (NINR) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Art Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33444178 | Background | 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. | |
| 37457095 | Background | 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. |
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| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
318 BC survivors over the age of 18 signed informed consent and were randomized to one of two groups, 289 completed baseline measurements.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The posted data are raw, before multiple imputations. | Posted | Mean | Standard Deviation | score on a scale | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3) |
|
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.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| disease progression AE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | disease progression AE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | General disorders | Non-systematic Assessment | Participant diagnosed with covid and could not continue participation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johanna Czamanski-Cohen | University of Haifa | +97246146234 | jczamansk@univ.haifa.ac.il |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form: REPAT study protocol | Oct 14, 2018 | Aug 14, 2023 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 14, 2017 | Oct 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D005221 | Fatigue |
| D010146 | Pain |
| D007249 | Inflammation |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001155 | Art Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| NIH |
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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.
|
| Sham Art Therapy | Behavioral | In a group setting participants will engage in Mandala coloring |
|
| 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''). | 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. | 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). | 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. | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3) |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | t-score | 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 | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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''). | We utilized maximum likelihood, and here are presented raw data, in which if a participant missed one question, the data was marked as missing. | Posted | Mean | Standard Deviation | score on a scale | 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 | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 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 | 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). | 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. | Posted | Mean | Standard Deviation | pcg/ml | 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 | 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. | 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, | Posted | Mean | Standard Deviation | miliseconds | Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3) |
|
|
|
| 1 |
| 146 |
| 8 |
| 146 |
| 16 |
| 146 |
| EG001 | 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 | 1 | 143 | 6 | 143 | 15 | 143 |
|
| prolonged hospitalization AE | General disorders | Non-systematic Assessment | The participant is hospitalized due to a health condition |
|
| surgery adverse event reporting | Surgical and medical procedures | Non-systematic Assessment | Entered into an implant removal surgery with infection |
|
| Car accident | General disorders | Non-systematic Assessment | Pain from car accident |
|
|
| Side effect from medication or vaccine- not study related | General disorders | Non-systematic Assessment |
|
| In mourning | Social circumstances | Non-systematic Assessment | Participant relative or close friend died, so did not attend |
|
| Stress from family illness | Social circumstances | Non-systematic Assessment |
|
| War | Social circumstances | Non-systematic Assessment | Participants not attending/ stress from war situation |
|
| Injury | General disorders | Non-systematic Assessment | Participant broke leg |
|
| Medication | General disorders | Non-systematic Assessment | Participant did not provide ECG because of a medication she is taking for pain |
|
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| D009461 | Neurologic Manifestations |
| D010335 | Pathologic Processes |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| T2 |
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| Pain intensity T2 |
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| Avoidance T1 |
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