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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208243
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : March 19, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Creative Arts Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders
Actual Study Start Date : September 29, 2010
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Peds QL—Cancer module [ Time Frame: 3-6 months ]
    The PedsQL 4.0 Cancer Module employs a Parent-Proxy Report for ages 2-18 years and a companion Child Self-Report for children aged five years and older. Validity and reliability testing for both the Core Scale and Cancer Module has been extensive. Reliability, assessed by internal consistency, yielded coefficient alphas ranging from .80-.90 across total and individual scales and are, thus, appropriate for the group comparisons planned in this study. The Cancer Module is a 27-item instrument that assesses eight subscales (Pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication). It is easily completed by parents in less than 10 minutes and reverse-scored and linearly-transformed in five minutes or less.

  2. The Resilience Scale (RS) [ Time Frame: 3-6 months ]
    The RS-14 is a 14-item scale using a 7-point rating (1-7). 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 (Wagnild & Young, 1993). Many studies have validated that the scale may be used with samples of any age or ethnic background (Ahern et al, 2006), but it is written at a 6th grade level. The authors who developed the tool are currently using it in adolescents (personal communication, 5/25/10). 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.

  3. Faces Scale [ Time Frame: 3-6 months ]
    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. Consistent rating was measured by children over 5 years regardless of age, gender, or health status (McGrath, 1990). The scale is a facial affective scale and has been integrated as a routine measure for management of acute, recurrent, and chronic pain (McGrath, 1990; McGrath et al., 1996). For children less than 3 years old, parents will be 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.

  4. Postural Measurement [ Time Frame: 3-6 months ]
    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. Clinical assessment of the thoracic kyphosis angle is considered essential in postural examination, but can be time consuming when measured radiographically (Lewis, 2010). 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 (Lewis, 2010).


Secondary Outcome Measures :
  1. Patient/Family Surveys [ Time Frame: 3-6 months ]
    A brief ten minute written survey will be administered to subjects to ascertain level of satisfaction with the program.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208243


Contacts
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Contact: Barbara Shepperd 720-777-6819 barbara.shepperd@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Denver, Colorado, United States, 80045
Contact: Barbara Shepperd    720-777-6819    barbara.shepperd@childrenscolorado.edu   
Principal Investigator: Jennifer Raybin         
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Children's Hospital Colorado
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04208243    
Other Study ID Numbers: 10-1028.cc
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Diseases