Music Therapy Video Development in Improving Communication, Emotional Distress, and Recovery in Adolescents/Young Adults Undergoing Treatment for High-Risk Cancer and Their Parents
Music Video for AYA-Parent Communication and Resilience
7 other identifiers
interventional
124
1 country
8
Brief Summary
This randomized trial studies how well music therapy and parents' education work in improving communication, emotional distress, and recovery in adolescents/young adult patients undergoing treatment for high-risk cancer and their parents. Making a music therapy video may improve communication, emotional distress, and recovery in younger patients undergoing treatment for cancer. It is not yet known whether music therapy and counseling for parents is more effective than information handouts for parents in improving communication and emotional distress in patients undergoing treatment for cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2012
CompletedFirst Posted
Study publicly available on registry
March 16, 2012
CompletedStudy Start
First participant enrolled
April 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2023
CompletedOctober 10, 2023
October 1, 2023
4.4 years
March 15, 2012
October 6, 2023
Conditions
Outcome Measures
Primary Outcomes (17)
AYA illness-related distress measured by the Mishel Uncertainty in Illness Scale and the McCorkle Symptom Distress scale
The MPLUS software will be used to perform latent variable analysis of covariance (ANCOVA) to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA defensive coping measured by the Jalowiec Coping Scale-Revised
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA spiritual perspective measured by the Reed Spiritual Perspective Scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA social integration measured by the Perceived Social Support-Family scale, the Perceived Social Support-Friends scale, and the Perceived Social Support-Health Care Providers
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA family environment measured by the Family Adaptability and Cohesion Scale II
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA family environment measured by the Parent-Adolescent Communication scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA family environment measured by the Family Strengths Scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA positive coping measured by the Jalowiec Coping Scale-Revised
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA hope-derived meaning measured by the Herth Hope Index
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA self-transcendence measured by the Reed Self-Transcendence scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
AYA resilience measured by the Nowotny Confidence subscale, the Haase Resilience in Illness Scale, and the Index of Well-Being
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
Parental distress measured by the Perceived Stress Scale, the Profile of Mood States-Short Form, and the Spielberger's State-Trait Anxiety Inventory-State Component
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
Parent family environment measured by the Family Adaptability and Cohesion Scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
Parent family environment measured by the Parent-Adolescent Communication scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
Parent family environment measured by the Family Strengths Scale
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
Parent family environment measured by the Perceived Social Support-Health Care Providers
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
Parent quality of life measured by the Index of Well-being
The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.
Up to 90 days
Study Arms (2)
Arm I (TMV)
EXPERIMENTALSee detailed description.
Arm II (TMV+P)
EXPERIMENTALSee detailed description.
Interventions
Ancillary studies
Eligibility Criteria
You may qualify if:
- AYA has initial or relapsed cancer diagnosis and is actively on treatment and will continue to be on treatment long enough to complete the intervention and evaluation (4 to 6 weeks)
- AYA meets at least 1 of 3 criteria indicating potentially high palliative care or end-of-life needs:
- Any high-risk cancer (i.e., metastatic or stage IV)
- Receiving moderate- to high-intensity chemotherapy during 3-5 consecutive days in an in- or out-patient setting
- A diagnosis with an estimated 5-year event-free survival of \< 50%
- AYA is able to participate in sessions as evaluated by the Karnofsky/Lansky score of 50% or greater
- One consistent parent is willing and available to participate in all parent and evaluation sessions
- AYA is not married and has no children
- AYA and parent are able to read, understand, and speak English
You may not qualify if:
- Cancers not usually occurring in childhood/adolescent or young adult populations, such as lung or prostate cancer
- Cognitive impairments that would make it difficult for AYA/parents to participate in the intervention or complete questionnaires (determination in consultation with attending physician, oncologist, and, for adolescents below age 18, the parents)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (8)
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322, United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan E Haase
Children's Oncology Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2012
First Posted
March 16, 2012
Study Start
April 23, 2012
Primary Completion
August 31, 2016
Study Completion
October 2, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10