Evaluating the Effectiveness of Art Therapy on Mood, Anxiety, and Pain Levels in Cancer Patients

Study Overview
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Brief Summary
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Participants in this research study are asked to tell about their experience with art therapy. Participants in this research study are currently receiving chemotherapy treatment for cancer. The purpose of this study is to learn how art therapy affects mood, anxiety, pain, and emotions of individuals with cancer who are undergoing chemotherapy.

Detailed Description
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In this single-center single-arm non-controlled descriptive study, we aim to describe the effects of a single art therapy session on a cancer patient's mood, pain, anxiety level. Primary Objectives To assess the effect of art therapy on the cancer patient's mood To assess the effect of art therapy on the cancer patient's anxiety To assess the effect of art therapy on the cancer patient's pain Secondary Objectives To explore differences in response to art therapy by ethnic group, race, age, sex, caregiver support, cancer diagnosis, reason for visit, and marital status To explore differences in response to art therapy by primary concern expressed by patients during art therapy sessions

Official Title
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Evaluating the Effectiveness of Art Therapy on Mood, Anxiety, and Pain Levels in Cancer Patients Undergoing Chemotherapy Treatment

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Emotions Thermometer
* Behavioral: Art Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are able to give informed consent Any cancer diagnosis Actively undergoing any chemotherapy treatment at Maroone Cancer Center Patients who have never utilized art therapy at Maroone Cancer Center Speaks, reads, and writes in English Able and willing to participate in an art therapy session at Maroone Cancer Center Exclusion Criteria: Patients without cancer diagnosis Patients not actively undergoing chemotherapy at Maroone Cancer Center Individuals unable to complete art therapy activities independently due to physical and/or mental impairment Under 18 years of age (minors) Patients who have dementia or a legal guardian Unable to speak, read, and write in English Patients who have previously utilized art therapy at Maroone Cancer Center

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Art Therapy<br>The art therapy intervention will be executed by an art therapist at the Cancer Center. The same art therapy practices that are utilized in daily practice will be employed in this study. The intervention will include assessment of patient's needs and goals in addition to utilization of various art modalities. Sessions will conclude with processing of the art and supportive counseling as appropriate. Pilot testing of the intervention has been performed informally at Maroone Cancer Center with positive feedback provided by patients and their support systems to the physicians, nurses, and art therapist. Change in pain, emotional distress, depression, adn anxiety will be measured by the emotions thermometer. | Behavioral: Emotions Thermometer<br>* The Emotions Thermometer, was chosen to assess patients' mood, anxiety level, and pain scale for this study. For patient ease, the study team chose to utilize a scale of 1-10 for all subjective measurements to be obtained from patients (mood and anxiety level). The study team included the thermometer image to mirror the NCCN Guidelines Version Distress Management Screening tool, for measuring distress and mood level. This screening tool has been shown to be effective in assessing patient distress and mood in oncology patients with ease of use in patients and utility in providers.<br>Behavioral: Art Therapy<br>* Each participant will participate in a private art therapy session with the Art Therapist for 50 minutes. The participant will have a choice of materials to work with, including painting, drawing, clay, and collage materials. The session will conclude with processing of the art and supportive counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of art therapy on the cancer patient's mood | The primary endpoint of the trial is to access the effect of an art therapy session on the patients' mood, anxiety level, and pain. To accomplish this, patients will complete four visual analog scales (VAS) prior to and after the session. The primary end points are the pre-and post session changes in the VAS. | Change from baseline to after intervention, about 50 minutes | 
| The effect of art therapy on the cancer patient's anxiety | The primary endpoint of the trial is to access the effect of an art therapy session on the patients' mood, anxiety level, and pain. To accomplish this, patients will complete four visual analog scales (VAS) prior to and after the session. The primary end points are the pre-and post session changes in the VAS. | Change from baseline to after intervention, about 50 minutes | 
| The effect of art therapy on the cancer patient's pain | The primary endpoint of the trial is to access the effect of an art therapy session on the patients' mood, anxiety level, and pain. To accomplish this, patients will complete four visual analog scales (VAS) prior to and after the session. The primary end points are the pre-and post session changes in the VAS. | Change from baseline to after intervention, about 50 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and ethnic group of patients | The secondary goal is to assess, in an exploratory manner, associations between VAS scores (baseline and changes) and patient characteristics as well as patients' expressed primary concerns. Data will be analyzed using methods such as 2-sample and paired t-tests, ANOVA, and Pearson correlations. | Change from baseline to after intervention, about 50 minutes | 
| exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and race of patients | The secondary goal is to assess, in an exploratory manner, associations between VAS scores (baseline and changes) and patient characteristics as well as patients' expressed primary concerns. Data will be analyzed using methods such as 2-sample and paired t-tests, ANOVA, and Pearson correlations. | Change from baseline to after intervention, about 50 minutes | 
| exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and age of patients | The secondary goal is to assess, in an exploratory manner, associations between VAS scores (baseline and changes) and patient characteristics as well as patients' expressed primary concerns. Data will be analyzed using methods such as 2-sample and paired t-tests, ANOVA, and Pearson correlations. | Change from baseline to after intervention, about 50 minutes | 
| exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and sex of patients | The secondary goal is to assess, in an exploratory manner, associations between VAS scores (baseline and changes) and patient characteristics as well as patients' expressed primary concerns. Data will be analyzed using methods such as 2-sample and paired t-tests, ANOVA, and Pearson correlations. | Change from baseline to after intervention, about 50 minutes | 
| exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and caregiver support of patients | The secondary goal is to assess, in an exploratory manner, associations between VAS scores (baseline and changes) and patient characteristics as well as patients' expressed primary concerns. Data will be analyzed using methods such as 2-sample and paired t-tests, ANOVA, and Pearson correlations. | Change from baseline to after intervention, about 50 minutes | 
| exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and cancer diagnosis of patients | The secondary goal is to assess, in an exploratory manner, associations between VAS scores (baseline and changes) and patient characteristics as well as patients' expressed primary concerns. Data will be analyzed using methods such as 2-sample and paired t-tests, ANOVA, and Pearson correlations. | Change from baseline to after intervention, about 50 minutes | 
| exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and reason for visit of patients | The secondary goal is to assess, in an exploratory manner, associations between VAS scores (baseline and changes) and patient characteristics as well as patients' expressed primary concerns. Data will be analyzed using methods such as 2-sample and paired t-tests, ANOVA, and Pearson correlations. | Change from baseline to after intervention, about 50 minutes | 
| exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and marital status of patients | The secondary goal is to assess, in an exploratory manner, associations between VAS scores (baseline and changes) and patient characteristics as well as patients' expressed primary concerns. Data will be analyzed using methods such as 2-sample and paired t-tests, ANOVA, and Pearson correlations. | Change from baseline to after intervention, about 50 minutes | 
| exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and primary concern expressed by patients during art therapy session | The secondary goal is to assess, in an exploratory manner, associations between VAS scores (baseline and changes) and patient characteristics as well as patients' expressed primary concerns. Data will be analyzed using methods such as 2-sample and paired t-tests, ANOVA, and Pearson correlations. | Change from baseline to after intervention, about 50 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Art Therapy, Chemotherapy