Music Therapy Video Development in Improving Communication, Emotional Distress, and Recovery in Adolescents/Young Adults Undergoing Treatment for High-Risk Cancer and Their Parents
RATIONALE: 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.
PURPOSE: 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.
Psychosocial Effects of Cancer and Its Treatment
Unspecified Childhood Solid Tumor, Protocol Specific
Behavioral: telephone-based intervention
Other: communication intervention
Other: educational intervention
Other: internet-based intervention
Other: questionnaire administration
Procedure: music therapy
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Masking: Open Label
|Official Title:||Music Video for AYA-Parent Communication and Resilience|
- Illness-related distress and defensive, spiritual perspective, social integration, family environment, positive coping, hope-derived meaning, and resilience and self-transcendence in the AYA TMV+P arm compared to the TMV intervention arm [ Designated as safety issue: No ]
- Distress (perceived stress, mood, anxiety), family environment, and quality of life (well-being) of parents in the TMV+P arm compared to the TMV intervention arm [ Designated as safety issue: No ]
- AYA/parents' perspective of TMV+P meaningfulness/helpfulness [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
- 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.
- Compare the efficacy of a TMV intervention with a TMV+P intervention on outcomes for parents of AYA with high-risk cancer.
- 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.
|United States, Georgia|
|AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Todd M. Cooper 404-785-1838|
|United States, Indiana|
|Riley's Children Cancer Center at Riley Hospital for Children||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: James M. Croop 317-944-8784|
|United States, Minnesota|
|Children's Hospitals and Clinics of Minnesota - Minneapolis||Recruiting|
|Minneapolis, Minnesota, United States, 55404|
|Contact: Clinical Trials Office - Children's Hospitals and Clinics of M 612-813-5193|
|United States, Texas|
|Cook Children's Medical Center - Fort Worth||Recruiting|
|Fort Worth, Texas, United States, 76104|
|Contact: Clinical Trials Office - Cook's Children's Medical Center 682-885-2103|
|University of Texas Health Science Center at San Antonio||Recruiting|
|San Antonio, Texas, United States, 78207|
|Contact: Anne-Marie R. Langevin 210-567-7477|
|Principal Investigator:||Joan E. Haase, PhD, RN||Indiana University Melvin and Bren Simon Cancer Center|