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

NCT02659345 | Completed DMC

• 1 other identifier: CASE5Z15
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Art Therapy; Chemotherapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and ethnic group of patients

  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

  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

  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

  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

  Change from baseline to after intervention, about 50 minutes

Study Arms (1)

Art Therapy

EXPERIMENTAL

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; Behavioral: Art Therapy

Interventions

Emotions Thermometer BEHAVIORAL

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

Art Therapy BEHAVIORAL

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.

Art Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Maroone Cancer Center - Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Art Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Steven Roshon, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 20, 2016
• Study Start: May 1, 2015
• Primary Completion: January 25, 2016
• Study Completion: January 25, 2017
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)