Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders
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|ClinicalTrials.gov Identifier: NCT04208243|
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : March 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Creative Arts Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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).
- 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.
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
|Contact: Barbara Shepperdfirstname.lastname@example.org|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Denver, Colorado, United States, 80045|
|Contact: Barbara Shepperd 720-777-6819 email@example.com|
|Principal Investigator: Jennifer Raybin|