Music Therapy for Distress During Autologous Stem Cell Transplantation: A Randomized Trial
18 Years
N/A
Both
Anxiety Disorder, Chronic Myeloproliferative Disorders, Depression, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Pain
Trial Information
Music Therapy for Distress During Autologous Stem Cell Transplantation: A Randomized Trial
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized
Principal Investigator
Barrie R. Cassileth, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
00-134
NCT ID:
NCT00014482
Start Date:
December 2000
Completion Date:
March 2003
Related Keywords:
- Anxiety Disorder
- Chronic Myeloproliferative Disorders
- Depression
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Pain
- 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
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Anxiety Disorders
- Neoplasms
- Depression
- Depressive Disorder
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
