Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00014482|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 18, 2013
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|
- 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 Type :||Interventional (Clinical Trial)|
|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|
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
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Barrie R. Cassileth, PhD||Memorial Sloan Kettering Cancer Center|