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

NCT ID: NCT04208243

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-29
• Study Completion Date: 2023-03-22

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Oncology Patient

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.

Group Type: EXPERIMENTAL

Creative Arts Therapy

Intervention Type: BEHAVIORAL

The intervention will consist of approximately weekly CAT in the infusion center during cancer therapy. The interventionist is a Master's prepared, licensed dance/movement therapist who is experienced in music and art therapies as well. The CAT includes dance/movement such as playing with a parachute, simple yoga breathing and postures, and work with physioballs. The music includes singing, listening to music, and playing instruments. The art consists of drawing, finger painting, working with clay. The CAT may occur in individual sessions in private infusion rooms, or in groups in the middle of the infusion center. The CAT is not only a distraction, but also a therapeutic process addressing the stressors of cancer and its treatment. The "dose" of CAT will be recorded (number and type of sessions) and will be factored into the analysis.

Interventions

Creative Arts Therapy

The intervention will consist of approximately weekly CAT in the infusion center during cancer therapy. The interventionist is a Master's prepared, licensed dance/movement therapist who is experienced in music and art therapies as well. The CAT includes dance/movement such as playing with a parachute, simple yoga breathing and postures, and work with physioballs. The music includes singing, listening to music, and playing instruments. The art consists of drawing, finger painting, working with clay. The CAT may occur in individual sessions in private infusion rooms, or in groups in the middle of the infusion center. The CAT is not only a distraction, but also a therapeutic process addressing the stressors of cancer and its treatment. The "dose" of CAT will be recorded (number and type of sessions) and will be factored into the analysis.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Colorado

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital Colorado

Denver, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

10-1028.cc

Identifier Type: -

Identifier Source: org_study_id