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

Primary Purpose

Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Creative Arts Therapy
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oncology Patient

Arm 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.

Outcomes

Primary Outcome Measures

PedsQL 3.0 Cancer Module Scale
The PedsQL 3.0 Cancer Module evolved from the PedsQL 4.0 Generic Core Scale. The instrument employs a Parent-Proxy Report for ages 2-18 years & a companion Child Self-Report for children 5 years and up. The Cancer Module is a 27-item instrument assessing 8 subscales (pain & hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, & communication). The PedsQL has been shown to be the most responsive to change when compared with other measures of QOL used with children undergoing chemotherapy. Reliability, assessed by internal consistency, yielded coefficient alphas ranging from .80-.90 across total & individual scales and are, thus, appropriate for group comparisons in this study. It is easily completed by parents in10 minutes and reverse-scored and linearly-transformed in five minutes. This tool uses a 0-100 score value system. The higher the score, the better the outcome. The subscales are summed to compute the total score.
The Resilience Scale (RS)
The RS-14 is a 14-item scale using a 7-point rating (1-7). Higher scores mean superior levels of resilience tendencies, and each of the 14 items on the scale was summed to obtain a total score, so the theoretical full range is from 14 to 98. The construct of resilience is measured by two factors: personal competence and acceptance of self and life. Wagnild and Young have completed psychometric testing that established internal consistency reliability and concurrent validity. Many studies have validated that the scale may be used with samples of any age or ethnic background, but it is written at a 6th grade level. The authors who developed the tool are currently using it in adolescents. Given that it is expected that half the population of this study will be teenagers, this tool will be used with subjects ages 12 and over to obtain initial data on CAT's effect on resilience.
McGrath Faces Scale
The Faces Scale has been used for evaluating emotional responses to pain on children 3-17 years old. It is a one page form with nine faces in order of happy to upset. Numerical values are given to each face as determined by childrens' perspectives for an affective value by asking 200 children to directly scale the feelings depicted by the faces. The scale has been integrated as a routine measure for management of acute, recurrent, and chronic pain. For children under 3 years old, parents are asked to complete the Faces Scale. Although this scale has been used for emotional response to pain, it is felt to be an appropriate measure for the emotional response to the discomfort and anxiety in the infusion room. The scale has 9 faces scored from 1-9. The higher the number, the worse the pain. The scores are not summed or averaged, this tool has only 1 score with the range of 1 to 9. 1 is most positive emotional response and 9 is most negative emotional response.
Postural Measurement by Inclinometer
Thoracic kyphosis will be measured using 2 gravity dependent inclinometers (Isomed Inc.). Spinal processes will be determined by palpation by a registered nurse or pediatric nurse practitioner. The feet of the inclinometers will be placed over the spinal processes thought to be at T1, T2 and T12, L1. The measurements will be taken in relaxed standing and measured 3 times in succession with the average of the 3 measures as the final value. Clinical assessment of the thoracic kyphosis angle is considered essential in postural examination, but can be time consuming when measured radiographically. The test-re-test reliability established excellent intra-rater reliability. Although validity of this measure is less studied, the measurement is thought to provide guidance of how much change of the kyphoscoliosis angle is a real consequence of intervention over time. Higher poster angle (from inclinometer) equals improved posture.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2019
Last Updated
March 30, 2023
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado
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1. Study Identification

Unique Protocol Identification Number
NCT04208243
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2010 (Actual)
Primary Completion Date
January 2, 2022 (Actual)
Study Completion Date
March 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oncology Patient
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Creative Arts Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
PedsQL 3.0 Cancer Module Scale
Description
The PedsQL 3.0 Cancer Module evolved from the PedsQL 4.0 Generic Core Scale. The instrument employs a Parent-Proxy Report for ages 2-18 years & a companion Child Self-Report for children 5 years and up. The Cancer Module is a 27-item instrument assessing 8 subscales (pain & hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, & communication). The PedsQL has been shown to be the most responsive to change when compared with other measures of QOL used with children undergoing chemotherapy. Reliability, assessed by internal consistency, yielded coefficient alphas ranging from .80-.90 across total & individual scales and are, thus, appropriate for group comparisons in this study. It is easily completed by parents in10 minutes and reverse-scored and linearly-transformed in five minutes. This tool uses a 0-100 score value system. The higher the score, the better the outcome. The subscales are summed to compute the total score.
Time Frame
7 months
Title
The Resilience Scale (RS)
Description
The RS-14 is a 14-item scale using a 7-point rating (1-7). Higher scores mean superior levels of resilience tendencies, and each of the 14 items on the scale was summed to obtain a total score, so the theoretical full range is from 14 to 98. The construct of resilience is measured by two factors: personal competence and acceptance of self and life. Wagnild and Young have completed psychometric testing that established internal consistency reliability and concurrent validity. Many studies have validated that the scale may be used with samples of any age or ethnic background, but it is written at a 6th grade level. The authors who developed the tool are currently using it in adolescents. Given that it is expected that half the population of this study will be teenagers, this tool will be used with subjects ages 12 and over to obtain initial data on CAT's effect on resilience.
Time Frame
7 months
Title
McGrath Faces Scale
Description
The Faces Scale has been used for evaluating emotional responses to pain on children 3-17 years old. It is a one page form with nine faces in order of happy to upset. Numerical values are given to each face as determined by childrens' perspectives for an affective value by asking 200 children to directly scale the feelings depicted by the faces. The scale has been integrated as a routine measure for management of acute, recurrent, and chronic pain. For children under 3 years old, parents are asked to complete the Faces Scale. Although this scale has been used for emotional response to pain, it is felt to be an appropriate measure for the emotional response to the discomfort and anxiety in the infusion room. The scale has 9 faces scored from 1-9. The higher the number, the worse the pain. The scores are not summed or averaged, this tool has only 1 score with the range of 1 to 9. 1 is most positive emotional response and 9 is most negative emotional response.
Time Frame
7 months
Title
Postural Measurement by Inclinometer
Description
Thoracic kyphosis will be measured using 2 gravity dependent inclinometers (Isomed Inc.). Spinal processes will be determined by palpation by a registered nurse or pediatric nurse practitioner. The feet of the inclinometers will be placed over the spinal processes thought to be at T1, T2 and T12, L1. The measurements will be taken in relaxed standing and measured 3 times in succession with the average of the 3 measures as the final value. Clinical assessment of the thoracic kyphosis angle is considered essential in postural examination, but can be time consuming when measured radiographically. The test-re-test reliability established excellent intra-rater reliability. Although validity of this measure is less studied, the measurement is thought to provide guidance of how much change of the kyphoscoliosis angle is a real consequence of intervention over time. Higher poster angle (from inclinometer) equals improved posture.
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Children's Hospital Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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