Depression Clinical Trial
Official title:
Music Therapy for Distress During Autologous Stem Cell Transplantation: A Randomized Trial
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.
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.
;
Allocation: Randomized
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