Clinical trial NCT02659345: Evaluating the Effectiveness of Art Therapy on Mood, Anxiety, and Pain Levels in Cancer Patients
Official title: Evaluating the Effectiveness of Art Therapy on Mood, Anxiety, and Pain Levels in Cancer Patients Undergoing Chemotherapy Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Art Therapy
Chemotherapy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility 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

Primary outcomes:
measure: The effect of art therapy on the cancer patient's mood
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: The effect of art therapy on the cancer patient's anxiety
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: The effect of art therapy on the cancer patient's pain
timeFrame: Change from baseline to after intervention, about 50 minutes
Secondary outcomes:
measure: exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and ethnic group of patients
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and race of patients
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and age of patients
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and sex of patients
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and caregiver support of patients
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and cancer diagnosis of patients
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and reason for visit of patients
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: exploratory assessment of the association between sum of pain, anxiety, and mood visual analog scale (VAS) scores and marital status of patients
timeFrame: Change from baseline to after intervention, about 50 minutes
measure: 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
timeFrame: Change from baseline to after intervention, about 50 minutes
Other outcomes:
Locations:
city: Weston
country: United States
facility: Maroone Cancer Center - Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Steven Roshon, MD
role: PRINCIPAL_INVESTIGATOR
References: