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Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00305851
First received: March 21, 2006
Last updated: February 12, 2014
Last verified: February 2014

March 21, 2006
February 12, 2014
April 2006
April 2012   (final data collection date for primary outcome measure)
  • Symptoms-related distress (pain, anxiety, fatigue, mucositis, sedation, and mood) [ Time Frame: pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
  • Uncertainty in illness as assessed by the Mishel Uncertainty in Illness Scale [ Time Frame: baseline, immediately after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
  • Use of defensive coping [ Time Frame: immediately after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
  • Use of positive coping [ Time Frame: immediately after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00305851 on ClinicalTrials.gov Archive Site
  • Communication with family as assessed by Parent-Adolescent Communication [ Time Frame: at baseline, immediately after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
  • Adaptability or cohesion as assessed by FACES II [ Time Frame: at baseline, immediately after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
  • Perceived social support from friends, family, and healthcare providers [ Time Frame: at baseline, immediately after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
  • Greater derived meaning from stem cell transplantation (STC) experience [ Time Frame: immediately after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
  • Higher resilience [ Time Frame: after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: at baseline, immediately after completion of study treatment, and 100 days post-transplant ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
Music Video and Adolescent/Young Adult Resilience During Transplant

RATIONALE: Music therapy or book discussion may improve quality of life in patients undergoing stem cell transplant. It is not yet known whether music therapy is more effective than book discussion in improving quality of life in patients undergoing stem cell transplant.

PURPOSE: This randomized phase III trial is studying how well music therapy works compared to listening and discussing books on tape in improving quality of life in young patients undergoing stem cell transplant.

OBJECTIVES:

  • Test the efficacy, in terms of resilience and quality of life, of a therapeutic music video (TMV) intervention vs listening and discussing books on tape (control group) for adolescents and young adults (AYA) undergoing autologous or allogeneic transplantation for cancer.
  • Qualitatively describe the perception of helpfulness and meaningfulness of a sub-group of both interventions for AYA and family members 100 days post-transplant.

OUTLINE: This is a randomized, controlled, limited multicenter study. Patients are randomized to 1 of 2 arms.

  • Arm I (books on tape [control group]): Patients undergo six 1-hour sessions twice a week for 3 weeks with a trained counselor in which they choose up to 3 books on CD and listen to the book and/or discuss their impressions and thoughts about the contents with the counselor. Patients are provided with a portable CD player to listen to the books during their hospitalization.
  • Arm II (therapeutic music video [TMV ] intervention): Patients undergo six 1-hour sessions twice a week for 3 weeks with a music therapist, designed specifically for the pre-transplant and acute phase of treatment. Phases of patient participation include song writing, recording the song with a digital accompaniment track, completing a video layout worksheet, taking photos or making drawings for the video, viewing clip art and pictures on a computer, and sharing the final video with family members and hospital staff.

In both arms, patients complete questionnaires before and after sessions 2, 4, and 6 with the music therapist. Patients also complete computer-based questionnaires before hospitalization, after session six during hospitalization, and at 100 days post-transplantation.

PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Cancer
  • Procedure: music therapy (books on tape)
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
  • Behavioral: Music Video
    Song writing, recording the song with a digital accompaniment track, completing a video layout worksheet (determining the contents of the video), taking photos or making drawings for the video, and viewing clip art and pictures on a computer.
  • Experimental: Low Dose Control "Books on Tape"
    Individuals randomly assigned to low-dose control group will have the same amount and timing of contacts as TMV group. A trained music therapist delivers the low-dose intervention (music therapy). Low-dose control group AYA initially choose up to three books-on-CD from a library selection of popular recordings. During the six sessions with the music therapist, AYA listens to the book and/or discusses their impressions and thoughts about he contents. Our rationale for having options of either listening to or discussing is to ensure the intervener has activities that will provide comparable contact time compared to the TMV group. As a parallel activity to the TMV protocol during which participants can work on their music video between sessions, AYA in the low-dose control group are provided with a portable CD player to listen to the books anytime during their hospitalization. As books ar e completed, or if the AYA changes their mind about the choice, the intervener offers other books.
    Interventions:
    • Procedure: music therapy (books on tape)
    • Procedure: psychosocial assessment and care
    • Procedure: quality-of-life assessment
  • Experimental: Experimental "Music Video"
    Intervention includes six 1-hour sessions (two sessions per week over 3 weeks) designed specifically for the pre-transplant and acute phase of treatment. The initial TMV session with the therapist occurs within 3 days of hospital admission. The phases of the intervention that require patient participation include song writing, recording the song with a digital accompaniment track, completing a video layout work sheet (determining the contents of the video), taking photos or making drawings for the video, and viewing clip art and pictures on a computer. The protocol concentrates many of these cognitive and active components to produce the video at the beginning, when patients experience less fatigue and malaise
    Interventions:
    • Procedure: psychosocial assessment and care
    • Procedure: quality-of-life assessment
    • Behavioral: Music Video
Robb SL, Burns DS, Docherty SL, Haase JE. Ensuring treatment fidelity in a multi-site behavioral intervention study: implementing NIH Behavior Change Consortium recommendations in the SMART trial. Psychooncology. 2011 Nov;20(11):1193-201. doi: 10.1002/pon.1845.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
118
Not Provided
April 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of an oncology condition requiring allogeneic or autologous transplantation
  • Receiving or planning to receive a myeloablative treatment regimen and 1 of the following:

    • Marrow transplantation
    • Peripheral stem cell transplantation
    • Cord blood stem cell transplantation
  • Patients with cancers that do not usually occur in childhood/adolescent or young adult populations (e.g., breast or prostate cancer) are not eligible

PATIENT CHARACTERISTICS:

  • Able to read and speak English

    • English does not need to be the primary language
  • Able to participate in the sessions as evaluated for alertness and engagement by the music therapist
  • No cognitive impairments that would make it difficult to participate in the intervention or complete questionnaires
  • Not married and not a parent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent therapy for pain control or relief of other symptoms allowed
Both
11 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00305851
ANUR0631, COG-ANUR0631, NCI-2009-00408
Yes
Children's Oncology Group
Children's Oncology Group
  • National Cancer Institute (NCI)
  • National Institute of Nursing Research (NINR)
Study Chair: Joan E. Haase, PhD, RN Indiana University Melvin and Bren Simon Cancer Center
Study Chair: Sheri L. Robb, PhD University of Missouri, Kansas City
Children's Oncology Group
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP