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

June 17, 2013 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Barrie R. Cassileth, PhD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-134
  • CDR0000068547 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-G01-1934

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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