Trial Outcomes & Findings for Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders (NCT NCT04208243)

NCT ID: NCT04208243

Last Updated: 2023-04-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

83 participants

Primary outcome timeframe

7 months

Results posted on

2023-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	83
Overall Study COMPLETED	83
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oncology Patient n=83 Participants 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. 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.
Age, Categorical <=18 years	83 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	7.8 years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	79 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	83 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 months

Outcome measures

Outcome measures
Measure	Oncology Patient n=83 Participants 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. 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.
PedsQL 3.0 Cancer Module Scale	71.59 score on a scale Standard Deviation 16.14

PRIMARY outcome

Timeframe: 7 months

Population: This scale is utilized only for patients 12 and older.

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.

Outcome measures

Outcome measures
Measure	Oncology Patient n=19 Participants 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. 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.
The Resilience Scale (RS)	82.86 score on a scale Standard Deviation 8.68

PRIMARY outcome

Timeframe: 7 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. 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.

Outcome measures

Outcome measures
Measure	Oncology Patient n=83 Participants 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. 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.
McGrath Faces Scale	2.89 score on a scale Standard Deviation 1.79

PRIMARY outcome

Timeframe: 7 months

Population: Participants were provided the option to decline the posture measure if the did not feel well enough to participate.

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.

Outcome measures

Outcome measures
Measure	Oncology Patient n=68 Participants 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. 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.
Postural Measurement by Inclinometer	25.47 degrees Standard Deviation 9.22

Adverse Events

Oncology Patient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Raybin

Children's Hospital Colorado

Phone: 720-777-3407

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place