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Completed

NCT Number: NCT02659345

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maroone Cancer Center - Cleveland Clinic Florida

Weston, Florida, 33331, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jan 20, 2016
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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