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

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ClinicalTrials.gov Identifier: NCT00305851
Recruitment Status : Completed
First Posted : March 22, 2006
Last Update Posted : February 23, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cancer Procedure: music therapy (books on tape) Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Behavioral: Music Video Phase 3

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Music Video and Adolescent/Young Adult Resilience During Transplant
Study Start Date : April 2006
Actual Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia Burkitt Lymphoma Soft Tissue Sarcoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Neuroblastoma Myelodysplastic Syndromes Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Lymphosarcoma Hairy Cell Leukemia Follicular Lymphoma B-cell Lymphoma Mantle Cell Lymphoma Diffuse Large B-Cell Lymphoma Hodgkin Lymphoma Hodgkin Lymphoma, Childhood Marginal Zone Lymphoma Osteosarcoma Ewing Sarcoma Ewing's Family of Tumors Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Gestational Trophoblastic Tumor Cutaneous T-cell Lymphoma Chronic Myeloid Leukemia Ovarian Epithelial Cancer Myelofibrosis Chronic Myeloproliferative Disorders Brain Tumor, Childhood Mycosis Fungoides Testicular Cancer Lymphoma, Large-cell Myelodysplastic/myeloproliferative Disease Sezary Syndrome Lymphoblastic Lymphoma Wilms' Tumor Brain Tumor, Adult Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Ovarian Germ Cell Tumor Chronic Neutrophilic Leukemia
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.
 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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Use of defensive coping [ Time Frame: immediately after completion of study treatment, and 100 days post-transplant ]
  4. Use of positive coping [ Time Frame: immediately after completion of study treatment, and 100 days post-transplant ]

Secondary Outcome Measures :
  1. Communication with family as assessed by Parent-Adolescent Communication [ Time Frame: at baseline, immediately after completion of study treatment, and 100 days post-transplant ]
  2. Adaptability or cohesion as assessed by FACES II [ Time Frame: at baseline, immediately after completion of study treatment, and 100 days post-transplant ]
  3. Perceived social support from friends, family, and healthcare providers [ Time Frame: at baseline, immediately after completion of study treatment, and 100 days post-transplant ]
  4. Greater derived meaning from stem cell transplantation (STC) experience [ Time Frame: immediately after completion of study treatment, and 100 days post-transplant ]
  5. Higher resilience [ Time Frame: after completion of study treatment, and 100 days post-transplant ]
  6. Quality of life [ Time Frame: at baseline, immediately after completion of study treatment, and 100 days post-transplant ]

Eligibility Criteria
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Ages Eligible for Study:   11 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305851


Locations
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, Georgia, United States, 30322
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St. Louis, Missouri, United States, 63110
United States, Texas
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00305851     History of Changes
Other Study ID Numbers: ANUR0631
COG-ANUR0631 ( Other Identifier: Children's Oncology Group )
NCI-2009-00408 ( Other Identifier: NCI Trial Identifier )
First Posted: March 22, 2006    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Children's Oncology Group:
fatigue
pain
psychosocial effects of cancer and its treatment
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia, BCR-ABL1 negative
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
 childhood chronic myelogenous leukemia
chronic eosinophilic leukemia
primary myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
juvenile myelomonocytic leukemia
myelodysplastic/myeloproliferative neoplasm, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma