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Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Cancer

Treatments

Behavioral: Creative Arts Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04208243
10-1028.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

83 participants in 1 patient group

Oncology Patient
Experimental group
Description:
Any Oncology patient in the CCBD who has not previously received more than two sessions of CAT in the outpatient unit and who will be receiving approximately weekly infusions of at least one hour in the infusion center will be identified by a research assistant.
Treatment:
Behavioral: Creative Arts Therapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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