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

NCT ID: NCT00014482

Last Updated: 2013-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2003-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety Disorder Chronic Myeloproliferative Disorders Depression Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Pain

Study Design

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Allocation Method

RANDOMIZED

Interventions

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pain therapy

Intervention Type PROCEDURE

psychosocial assessment and care

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Principal Investigators

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Barrie R. Cassileth, PhD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CDR0000068547

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G01-1934

Identifier Type: -

Identifier Source: secondary_id

00-134

Identifier Type: -

Identifier Source: org_study_id

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