Music Therapy Video Development in Improving Communication, Emotional Distress, and Recovery in Adolescents/Young Adults Undergoing Treatment for High-Risk Cancer and Their Parents
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      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.
    

Intervention name(s): Caregiver-Related Intervention or Procedure; Music Therapy; Music Therapy; Quality-of-Life Assessment; Questionnaire Administration
Intervention type(s): Other; Procedure; Procedure; Other; Other
Intervention description(s): Undergo TMV+P; Undergo TMV; Undergo TMV+P; Ancillary studies; Ancillary studies
Other intervention name(s): Quality of Life Assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care