- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085927
Mechanisms of Active Music Engagement to Improve Health Outcomes of Children With Cancer and Parents (PINPOINT)
October 15, 2021 updated by: Sheri Robb, Indiana University
Music therapy, a frequently used arts-based therapy, has become standard palliative care in many pediatric and adult hospitals; however, few studies have examined the mechanisms by which music therapy interventions work.
This study investigates behavioral, social, and psychological factors that may explain how an Active Music Engagement (AME) intervention (i.e., an interactive, music-based play intervention) works to manage emotional distress and improve positive health outcomes in parents and young children with cancer during treatment.
Findings will provide scientific and clinically relevant practice knowledge to guide delivery of music therapy as a complementary therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Music therapy, a frequently used arts-based therapy, has become standard palliative care in many pediatric and adult hospitals; however, few studies have examined mechanisms by which music therapy interventions work.Based on the Contextual Support Model of Music Therapy, the investigators developed and tested the Active Music Engagement (AME) intervention, establishing it as a feasible and acceptable intervention that reduces emotional distress in young children (ages 3-8) hospitalized for cancer treatment.Emotional distress in young children with cancer during acute treatment and their parents is a prevalent,persistent problem associated with physical symptom distress and diminished quality of life and family function.
The music therapist-led AME uses music-based play and parent education/support (music play resource kit; tip sheets), is easy to implement, and teaches parents/children how to therapeutically use a familiar activity to manage distress.
The purpose of this two group randomized controlled trial is to identify behavioral, sociological, and psychological variables contributing to positive outcomes observed in previous AME studies (i.e., mediators) and identify for whom the intervention works (i.e., moderators).
The investigators will examine proximal mediators of child engagement and parent-child interaction and distal mediators of perceived family normalcy, parent confidence (self-efficacy) about their ability to support their child during treatment, and independent parent/child use of music and play activities to manage distress during hospitalization.
The investigators hypothesize these factors mediate change in outcomes of child emotional distress, physical symptom distress, and quality of life; parent emotional/traumatic distress and quality of life; and family function.
Specific aims are to examine: 1) effects of proximal and distal mediators of AME on young child/parent outcomes; 2) moderators of AME on young child/parent distress; 3) explore child physical symptom distress (pain, fatigue, nausea) in mediation and moderation models.
Child/parent dyads (n=184) will be stratified by age and randomized in blocks of 6 to AME or audio-storybooks; each group will receive three 45-minute sessions with a credentialed music therapist for 3 consecutive days with data collection at baseline, post-intervention, and 30 days later.
Mediation effects will be estimated using ANCOVA, fitting appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach to estimate indirect effect.
Moderation effects will be tested by including appropriate interaction terms of the potential moderator with the intervention indicator in our models.
Study Type
Interventional
Enrollment (Actual)
137
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Missouri
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Kansas City, Missouri, United States, 64155
- Children's Mercy Hospitals and Clinics
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Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria (Child/Parent):
- Children ages 3-8 years inclusive.
- Expected treatment course for at least 3 days to receive chemotherapy and/or radiation therapy.
- A consistent parent who can be present for all sessions.
Exclusion Criteria (Child/Parent):
- Child and/or parent do not speak English.
- Child has a significant cognitive impairment that hinders participation (based on physician judgment).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1-Active Music Engagement
Three 45-minute sessions with a board-certified music therapist delivered over three days.
Sessions are delivered in a private setting during in-patient hospitalization.
During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment.
The music therapist will lead parent and child in a variety of music play activities.
Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD.
During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
|
Three 45-minute sessions with a board-certified music therapist delivered over three days.
Sessions are delivered in a private setting during in-patient hospitalization.
During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment.
The music therapist will lead parent and child in a variety of music play activities.
Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD.
During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
|
Experimental: Arm II- Audio-Storybooks
Three 45-minute sessions with a board-certified music therapist delivered over three days.
Sessions are delivered in a private setting during in-patient hospitalization.
Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.
|
Three 45-minute sessions with a board-certified music therapist delivered over three days.
Sessions are delivered in a private setting during in-patient hospitalization.
Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family Normalcy Perspective - Family Management Measure (FaMM)
Time Frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Family Normalcy is assessed through The Family Management Measure (FaMM) - Family Life Difficulty Subscale includes 14-items rated on a 5-point Likert-type scale.
Subscale items address parents' perceptions of the extent to which having a child with a chronic condition makes family life difficult.
Higher values indicate more difficulty managing the condition.
Score range 14 - 70.
|
Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Parent Self-Efficacy - Parental Beliefs Scale (PBS).
Time Frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Parent Self-Efficacy is assessed through the Parental Beliefs Scale (PBS) for Hospitalized Children, a 20-item scale that measures parental beliefs about their confidence in anticipating changes in their hospitalized child's behavior and confidence in their parental role during hospitalization.
Scores range from 20-100, with higher scores indicating more positive beliefs.
|
Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Child Emotional Distress - Child Health Questionnaire (CHQ)
Time Frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Child Emotional Distress is assessed through the Child Health Questionnaire (CHQ-PF98) Mental Health Subscale (Landgraf et al., 1999).
This subscale consists of 16 items rated on a 5-point Likert-scale.
Scores range from 16 to 80 with lower scores indicating better mental health.
|
Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Child Quality of Life - KINDL.
Time Frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Child Quality of Life is assessed through the KINDL Questionnaire for Measuring Health-Related Quality of Life in Children.
The KINDL consists of 24 parent-report items rated on a 5-point Likert-scale for each subscale.
Scores range from 20-100 with higher scores indicating better quality of life.
|
Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Parent Emotional and Traumatic Stress Symptoms - Profile of Mood States-Short Form (POMS).
Time Frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Parent Emotional and Traumatic Distress was assessed through the Profile of Mood States - Short Form (POMS-SF) which measures mood disturbance.
There are 37 items which respondents rate on a 5-point Likert scale.
Scores range from 0 to 148 with higher scores indicating greater mood disturbance.
|
Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
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Parent Emotional and Traumatic Stress Symptoms - Impact of Events Scale-Revised (IES-R)
Time Frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Stress Symptoms assessed through the Impact of Events Scale-Revised (IES-R), a 22-item measure that measures traumatic stress symptoms in response to a traumatic event that is specified in the instructions.
Parents respond to each item using a 5-point Likert scale.
Scores range from 0 to 12 with higher scores indicating greater traumatic stress symptoms.
|
Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Parent Quality of Life - Index of Well Being.
Time Frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Parent Quality of Life is assessed through the Index of Well-being, a 9-item semantic differential scale describing present life using adjective extremes.
Scores range from 7 to 63 with higher scores meaning greater well-being.
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Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Family Function - Family Adaptability and Cohesion Scale (FACES II).
Time Frame: Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Family Function is assessed through the Family Adaptability and Cohesion Scale II (FACES II), a 30-item scale of items rated using a 5-point Likert scale.
Scores range from 1 to 5, with higher scores meaning higher family adaptability and cohesion.
|
Time 2(post-session 3 on day 3) and Time 3 (30-days post-session 3, approximately 33 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheri L Robb, PhD, Indiana University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Robb SL, Clair AA, Watanabe M, Monahan PO, Azzouz F, Stouffer JW, Ebberts A, Darsie E, Whitmer C, Walker J, Nelson K, Hanson-Abromeit D, Lane D, Hannan A. A non-randomized [corrected] controlled trial of the active music engagement (AME) intervention on children with cancer. Psychooncology. 2008 Jul;17(7):699-708. doi: 10.1002/pon.1301. Erratum In: Psychooncology. 2008 Sep;17(9):957.
- Robb SL, Haase JE, Perkins SM, Haut PR, Henley AK, Knafl KA, Tong Y. Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer. J Pediatr Psychol. 2017 Mar 1;42(2):208-219. doi: 10.1093/jpepsy/jsw050.
- Robb SL. The effect of therapeutic music interventions on the behavior of hospitalized children in isolation: developing a contextual support model of music therapy. J Music Ther. 2000 Summer;37(2):118-46. doi: 10.1093/jmt/37.2.118.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 26, 2016
Primary Completion (Actual)
April 6, 2020
Study Completion (Actual)
April 6, 2020
Study Registration Dates
First Submitted
February 27, 2017
First Submitted That Met QC Criteria
March 15, 2017
First Posted (Actual)
March 21, 2017
Study Record Updates
Last Update Posted (Actual)
November 11, 2021
Last Update Submitted That Met QC Criteria
October 15, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01NR015789 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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