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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

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ClinicalTrials.gov Identifier: NCT00014482
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Anxiety Disorder Chronic Myeloproliferative Disorders Depression Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Pain Procedure: pain therapy Procedure: psychosocial assessment and care Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Official Title: Music Therapy for Distress During Autologous Stem Cell Transplantation: A Randomized Trial
Study Start Date : December 2000
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): 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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00014482     History of Changes
Other Study ID Numbers: 00-134
CDR0000068547 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-G01-1934
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
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
primary 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

Additional relevant MeSH terms:
Lymphoma
Disease
Syndrome
Depression
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Anxiety Disorders
Plasmacytoma
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Behavioral Symptoms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Mental Disorders