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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659345
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Emotions Thermometer Behavioral: Art Therapy Not Applicable

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating the Effectiveness of Art Therapy on Mood, Anxiety, and Pain Levels in Cancer Patients Undergoing Chemotherapy Treatment
Study Start Date : May 2015
Actual Primary Completion Date : January 25, 2016
Actual Study Completion Date : January 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Art Therapy
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
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.

Behavioral: 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.




Primary Outcome Measures :
  1. The effect of art therapy on the cancer patient's mood [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  2. The effect of art therapy on the cancer patient's anxiety [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  3. The effect of art therapy on the cancer patient's pain [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.


Secondary Outcome Measures :
  1. exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and ethnic group of patients [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  2. exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and race of patients [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  3. exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and age of patients [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  4. exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and sex of patients [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  5. exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and caregiver support of patients [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  6. exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and cancer diagnosis of patients [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  7. exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and reason for visit of patients [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  8. exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and marital status of patients [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.

  9. 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 [ Time Frame: Change from baseline to after intervention, about 50 minutes ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659345


Locations
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United States, Florida
Maroone Cancer Center - Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Steven Roshon, MD Cleveland Clinic Florida
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02659345    
Other Study ID Numbers: CASE5Z15
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Case Comprehensive Cancer Center:
Art Therapy
Chemotherapy