Music Therapy Video Development in Improving Communication, Emotional Distress, and Recovery in Adolescents/Young Adults Undergoing Treatment for High-Risk Cancer and Their Parents

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01556256
First received: March 15, 2012
Last updated: August 21, 2014
Last verified: August 2014
  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. 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.


Condition Intervention Phase
Malignant Neoplasm
Procedure: music therapy
Other: caregiver-related intervention or procedure
Other: questionnaire administration
Other: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Music Video for AYA-Parent Communication and Resilience

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • AYA illness-related distress measured by the Mishel Uncertainty in Illness Scale and the McCorkle Symptom Distress scale [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    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.

  • AYA defensive coping measured by the Jalowiec Coping Scale-Revised [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • AYA spiritual perspective measured by the Reed Spiritual Perspective Scale [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • 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 [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • AYA family environment measured by the Family Adaptability and Cohesion Scale II, the Parent-Adolescent Communication scale, and the Family Strengths Scale [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • AYA positive coping measured by the Jalowiec Coping Scale-Revised [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • AYA hope-derived meaning measured by the Herth Hope Index [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • AYA self-transcendence measured by the Reed Self-Transcendence scale [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • AYA resilience measured by the Nowotny Confidence subscale, the Haase Resilience in Illness Scale, and the Index of Well-Being [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • 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 [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • Parent family environment, measured by the Family Adaptability and Cohesion Scale, the Parent-Adolescent Communication scale, the Family Strengths Scale, and the Perceived Social Support-Health Care Providers [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.

  • Parent quality of life measured by the Index of Well-being [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    The MPLUS software will be used to perform latent variable ANCOVA to account for measurement error and to reduce the number of comparisons.


Estimated Enrollment: 198
Study Start Date: April 2012
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (TMV)
See detailed description.
Procedure: music therapy
Undergo TMV
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II (TMV+P)
See detailed description.
Procedure: music therapy
Undergo TMV+P
Other: caregiver-related intervention or procedure
Undergo TMV+P
Other: questionnaire administration
Ancillary studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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.

  Eligibility

Ages Eligible for Study:   11 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556256

Locations
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Glen Lew    404-785-1112      
Principal Investigator: Glen Lew         
Children's Healthcare of Atlanta at Scottish Rite Recruiting
Atlanta, Georgia, United States, 30342
Contact: Joan E. Haase    317-278-7749    johaase@UPUI.edu   
Principal Investigator: Joan E. Haase         
United States, Indiana
Riley Hospital for Children Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Bruce C. Bostrom    612-813-5193      
Principal Investigator: Bruce C. Bostrom         
United States, Missouri
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Maxine L. Hetherington    816-234-3265      
Principal Investigator: Maxine L. Hetherington         
United States, Texas
Cook Children's Medical Center Withdrawn
Fort Worth, Texas, United States, 76104
University of Texas Health Science Center at San Antonio Active, not recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Joan Haase, PhD RN Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01556256     History of Changes
Other Study ID Numbers: ANUR1131, NCI-2012-00682, COG-ANUR1131, CDR0000726664, ANUR1131, COG-ANUR1131, ANUR1131, U10CA095861, R01CA162181, U10CA098543
Study First Received: March 15, 2012
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 27, 2014