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Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
This study has been completed.
First Received: April 10, 2001   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00014482
  Purpose

RATIONALE: Music therapy may be effective in relieving pain and emotional distress in patients who are undergoing cancer therapy.

PURPOSE: Randomized trial to determine the effectiveness of music therapy to ease pain and emotional distress in patients with hematologic cancer who are undergoing high-dose therapy and stem cell transplantation.


Condition Intervention
Cancer-Related Problem/Condition
Chronic Myeloproliferative Disorders
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Pain
 Procedure: pain therapy
Procedure: psychosocial assessment and care

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Anxiety Cancer Lymphoma Multiple Myeloma
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Active Control
Official Title: Music Therapy for Distress During Autologous Stem Cell Transplantation: A Randomized Trial

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

Study Start Date: December 2000
Detailed Description:

OBJECTIVES:

  • Compare the effects of music therapy vs no music therapy on depression and anxiety in patients with hematologic malignancies undergoing high-dose therapy and autologous stem cell transplantation.
  • Compare the effects of these regimens on mood, mucositis pain, pain interference, need for analgesic medication, and length of hospital stay of these patients.
  • Compare the immediate effects of these regimens on mood in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to whole body or whole lymphatic irradiation (yes vs no) and diagnosis (non-Hodgkin's lymphoma vs Hodgkin's lymphoma vs myeloma/amyloidosis). Patients are randomized to one of two arms.

  • Arm I: Patients receive individualized music therapy over 20-30 minutes beginning on day 0 and continuing over 16 days for a maximum of 12 sessions during high-dose therapy and autologous stem cell transplantation. Patients complete a Profile of Mood States (POMS) quality of life and pain questionnaire on days -2, 0, 1, 4, 7, 10, 13, and 16.
  • Arm II: Patients receive standard psychosocial support during high-dose therapy and autologous stem cell transplantation. Patients complete POMS and mucositis pain questionnaires as in arm I.

PROJECTED ACCRUAL: A total of 80 patients (40 per arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of a hematologic malignancy

    • No leukemia
  • Planned high-dose therapy and autologous stem cell transplantation (HDT/ASCT) at Memorial Sloan-Kettering Cancer Center

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior HDT/ASCT

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014482

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Barrie R. Cassileth, PhD Memorial Sloan-Kettering Cancer Center
  More Information

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

No publications provided

Study ID Numbers: CDR0000068547, MSKCC-00134, NCI-G01-1934
Study First Received: April 10, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00014482     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
anxiety disorder
depression
pain
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
chronic idiopathic myelofibrosis
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
 stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Follicular Lymphoma
Mycoses
Preleukemia
Hemorrhagic Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasm Metastasis
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Depression
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Myeloproliferative Disorders
 Depressive Disorder
Multiple Myeloma
B-cell Lymphomas
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Hematologic Neoplasms
Precancerous Conditions
Blood Protein Disorders
Lymphoma, Follicular
Pain
Lymphoma, B-Cell, Marginal Zone
Sezary Syndrome
Paraproteinemias
Mycosis Fungoides
Hemostatic Disorders

Additional relevant MeSH terms:
Precancerous Conditions
Blood Protein Disorders
Paraproteinemias
Hemostatic Disorders
Preleukemia
Pathologic Processes
Hemorrhagic Disorders
Syndrome
Lymphoma, Large-Cell, Immunoblastic
Cardiovascular Diseases
Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
 Disease
Immune System Diseases
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Vascular Diseases
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Bone Marrow Diseases
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 06, 2009



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