Clinical trial NCT04208243: Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders
Official title: Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2019-12-23
Enrollment: 83
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The subjects and/or parents will be tested with all instruments before the intervention, and approximately every 30 days for no less than 3 months and a max participation of 6 months. Treatment time points will be at least 30 days apart. For those subjects who are scheduled to come into clinic every 1-2 months for SOC appointments, study participation may take up to 6 months. This 6 month time period would allow for the completion of 4 time points of CAT. The testing will take place in an exam room after vital signs have been completed upon intake. The study staff will administer the questionnaires. The PedsQL includes a subject report (ages 5 and over) and a parent report. The Resilience Scale is a self-report and will be used for ages 12 and over. The Faces Scale will use parent report for ages less than 5 and self-report for ages 5 and over. For consistency, the posture measure will be completed by study staff after training with the manual included with the inclinometer tool.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate the effectiveness of Creative Arts Therapy (CAT) on pediatric patients undergoing chemotherapy in the Infusion Center at Children's Hospital Colorado Center for Cancer and Blood Disorders. Findings from a previous pilot study support the hypothesis that CAT may improve quality of life (QOL), resiliency, physical posture, and emotional response to pain of pediatric oncology patients undergoing chemotherapy.

Detailed description: A repeated measures design will be used with each patient serving as his/her own control. The subjects and/or parents will be tested with all instruments before the intervention, and approximately every 30 days for no less than 3 months and a maximum participation of 6 months. Treatment time points will be at least 30 days apart. Because some subjects are not scheduled to come into the clinic every 30 days for SOC appointments, they are unable to complete 3 sessions of CAT in a 3 month time period. For those subjects who are scheduled to come into clinic every 1-2 months for SOC appointments, study participation may take up to 6 months. This 6 month time period would allow for the completion of 4 different time points of CAT.

The testing will take place in an exam room after vital signs have been completed upon intake to the clinic. The trained research assistant, trained RN, or PI will administer the questionnaires. The PedsQL includes a subject report (ages 5 and over) and a parent report. The Resilience Scale is a self-report and will be used for ages 12 and over. The Faces Scale will use parent report for ages less than 5 and self-report for ages 5 and over. In order to confirm consistency, the posture measure will be completed by the PI (nurse practitioner) or registered nurse on the study after training with the manual included with the inclinometer tool.

Eligibility criteria: Inclusion Criteria:

* Center for Cancer and Blood Disorders (CCBD) patient with Oncology or Neuro-oncology diagnosis
* No more than 2 previous sessions of CAT as an outpatient in the CCBD
* English speaking
* Receiving outpatient chemotherapy, biotherapy, or transfusions in the infusion center approximately weekly for at least 3 months.
* Ages 3 to 18 years

Exclusion Criteria:

* Hematology or other patients in the infusion center
* Patients who have previously received more than 2 sessions of CAT in the infusion center
* Non-English speaking patients

Primary outcomes:
measure: PedsQL 3.0 Cancer Module Scale
timeFrame: 7 months
measure: The Resilience Scale (RS)
timeFrame: 7 months
measure: McGrath Faces Scale
timeFrame: 7 months
measure: Postural Measurement by Inclinometer
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References: