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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659345
• Other study ID #: CASE5Z15
• Status: Completed
• Phase: N/A
• First received: January 14, 2016
• Last updated: January 25, 2017
• Start date: May 2015
• Est. completion date: January 25, 2017

Study information

• Verified date: January 2017
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 25, 2017
• Est. primary completion date: January 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Emotions Thermometer
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.
• Art Therapy
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.

Locations

Country	Name	City	State
United States	Maroone Cancer Center - Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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