CancerNCT02659345
Evaluating the Effectiveness of Art Therapy on Mood, Anxiety, and Pain Levels in Cancer Patients
A study testing Emotions Thermometer and Art Therapy in people with Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Emotions Thermometer and Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 25 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Maroone Cancer Center - Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: Evaluating the Effectiveness of Art Therapy on Mood, Anxiety, and Pain Levels in Cancer Patients Undergoing Chemotherapy Treatment
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.
Read the 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
- Conditions
- Cancer
- Being tested
- Emotions Thermometer, Art Therapy
- Keywords
- Art Therapy, Chemotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotions ThermometerBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Emotions Thermometer; Behavioral: Art Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: Change from baseline to after intervention, about 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startMay 2015
- Primary completion25 Jan 2016
- Study completion25 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Roshon, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659345
- Sponsor's protocol ID
- CASE5Z15
- Status last verified
- Jan 2017
- First submitted
- 14 Jan 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Art Therapy on Mood, Anxiety, and Pain Levels in Cancer Patients Undergoing Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT02659345
- Acronym / sponsor ID
- CASE5Z15
- Conditions
- Cancer
- Keywords
- Art Therapy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 25 Jan 2016 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Art Therapy | Experimental | Behavioral: Emotions Thermometer, Behavioral: Art TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotions ThermometerThe 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. | Behavioural | Art Therapy |
| Art TherapyEach 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. | Behavioural | Art Therapy |
Primary outcome
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.
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.
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.
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Roshon, MD principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotions Thermometer and Art Therapy in people with Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of art therapy on the cancer patient's mood (time frame: Change from baseline to after intervention, about 50 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.