Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00014482
Collaborator
National Cancer Institute (NCI) (NIH)
1
26.9

Study Details

Study Description

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
  • Procedure: pain therapy
  • Procedure: psychosocial assessment and care
N/A

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

Study Type:
Interventional
Allocation:
Randomized
Official Title:
Music Therapy for Distress During Autologous Stem Cell Transplantation: A Randomized Trial
Study Start Date :
Dec 1, 2000
Actual Primary Completion Date :
Mar 1, 2003
Actual Study Completion Date :
Mar 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00014482
    Other Study ID Numbers:
    • 00-134
    • CDR0000068547
    • NCI-G01-1934
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 18, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 18, 2013