Music Therapy Video Development in Improving Communication, Emotional Distress, and Recovery in Adolescents/Young Adults Undergoing Treatment for High-Risk Cancer and Their Parents
NCT ID: NCT01556256
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
124 participants
INTERVENTIONAL
2012-04-23
2023-10-02
Brief Summary
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Detailed Description
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I. Compare the efficacy of a Therapeutic Music Video (TMV) intervention with a Therapeutic Music Video plus Parent (TMV+P) intervention on outcomes for adolescents/young adults (AYA) undergoing treatment for high-risk cancer.
II. Compare the efficacy of a TMV intervention with a TMV+P intervention on outcomes for parents of AYA with high-risk cancer.
III. Determine relationships of parent distress and parent perceived family environment with AYA outcomes using a mixed methods approach. (exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to age in years (11-13 vs 14-17 vs 18-24). Parents are randomized to 1 of 2 intervention arms.
ARM I (TMV, low-dose parent): AYA patients undergo 60-minute sessions, delivered in a private setting during outpatient clinic visits or hospitalizations, within a 6-8 weeks period with board-certified music therapists. The music therapists help patients in brainstorming and lyric writing, singing and creatively exploring how AYA lyrics and structure of the selected music fit together, recording their song with a digital accompaniment track, completing video layout worksheets (determining the contents of the video), taking and gathering photos or making drawings for the video, and viewing clip art and pictures on a computer. The music therapist then digitally formats, compiles, and transfers the AYA-developed music video to a DVD. When completed, the therapist shares the video with the AYA and offers the option of having a video "premiere." AYAs who choose a premiere select a date and time for the viewing and identify individuals they wish to attend (family, friends, healthcare professionals). After the viewing, AYAs receive a copy of their DVD to keep. Parents' presence and involvement during all sessions are directed by the AYAs. Parents receive 2 sessions over 15-60 minutes with a trained study team. During the first session, parents receive handouts of helpful website resources that have specific information to help parents support their AYAs. Team members also assure that parents know how to assess the sites. During the second session, parents receive audio-recorded, telephone-based contact by a trained nurse who asks them questions focusing on the content available on the provided website. The trained nurse also answers any questions parents may have.
ARM II (AYA TMV +P): AYA patients receive intervention as patients in arm I. Parents receive 3 tailored 60-minute sessions with a trained nurse intervener. Sessions are recorded to make sure study nurse delivers the sessions according to the study protocol. Study nurse provides support information to parents using the Robb's Contextual Support Model, including Managing the Chaos: Self Care as the First Step to Caring for Your AYA, Relationship Support: How to Listen to and Encourage Your AYA to Talk; and Strategies for AYA Autonomy Support: Understanding AYA's Ways of Coping. Session 3 content is also based on the Resilience in Illness model. Sessions are also tailored to parents' needs, skills practice and/or role playing, and reflection on and reinforcement of learning. Parents receive written materials on tips and prescribed skills practice plans. AYA and parents complete questionnaires including Illness-Related Distress, Defensive Coping, Spiritual Perspective, Social Integration, Family Environment questionnaires, Hope-Derived Meaning, Self-Transcendence, Positive Coping, Resilience, Parent Distress, and Quality of Life at baseline, at 2 weeks after final session, and then at 90 days after final intervention session. Medical background, intensity of treatment rating scale, and family demographics are also collected.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm I (TMV)
See detailed description.
Music Therapy
Undergo TMV
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (TMV+P)
See detailed description.
Caregiver-Related Intervention or Procedure
Undergo TMV+P
Music Therapy
Undergo TMV+P
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Caregiver-Related Intervention or Procedure
Undergo TMV+P
Music Therapy
Undergo TMV
Music Therapy
Undergo TMV+P
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
11 Years
24 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Joan E Haase
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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NCI-2012-00682
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000726664
Identifier Type: -
Identifier Source: secondary_id
COG-ANUR1131
Identifier Type: -
Identifier Source: secondary_id
ANUR1131
Identifier Type: OTHER
Identifier Source: secondary_id
COG-ANUR1131
Identifier Type: OTHER
Identifier Source: secondary_id
ANUR1131
Identifier Type: OTHER
Identifier Source: secondary_id
ANUR1131
Identifier Type: -
Identifier Source: org_study_id
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