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Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2008
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00305851
  Purpose

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 Intervention Phase
Cancer
Procedure: music therapy
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Phase III

MedlinePlus related topics: Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Active Control
Official Title: Music Video and Adolescent/Young Adult Resilience During Transplant

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Symptoms-related distress (pain, anxiety, fatigue, mucositis, sedation, and mood) at 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 at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Use of defensive coping as assessed immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Use of positive coping as assessed immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Communication with family as assessed by Parent-Adolescent Communication 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 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 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 immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Higher resilience immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Quality of life at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: April 2006
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   11 Years to 24 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305851

Locations
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Howard M. Katzenstein     404-785-0853        
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Robert J. Hayashi     314-454-4118        
United States, Texas
Methodist Children's Hospital of South Texas Recruiting
San Antonio, Texas, United States, 78229-3993
Contact: Michael S. Grimley     210-575-7268        
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Joan E. Haase, PhD, RN Indiana University Melvin and Bren Simon Cancer Center
Investigator: Sheri L. Robb, PhD University of Missouri, Kansas City
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000463879, COG-ANUR0631
Study First Received: March 21, 2006
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00305851  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
fatigue
pain
psychosocial effects/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
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic 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 disease, 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

Study placed in the following topic categories:
Juvenile myelomonocytic leukemia
Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Hodgkin lymphoma, adult
Malignant mesenchymal tumor
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Ovarian epithelial cancer
Small non-cleaved cell lymphoma
Osteogenic sarcoma
Lymphoma, large-cell, immunoblastic
Mycoses
Ewing's sarcoma
Preleukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasm Metastasis
Acute myeloid leukemia, adult
Hodgkin Disease
Rhabdomyosarcoma
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, B-cell, chronic
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Acute myelogenous leukemia

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009