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| Sponsor: | Wake Forest University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00376922 |
Purpose
RATIONALE: Listening to relaxing music during a bone marrow biopsy may be effective in reducing anxiety and pain.
PURPOSE: This randomized clinical trial is studying how well music works in reducing anxiety and pain in adult patients undergoing bone marrow biopsy for hematologic cancers or other diseases.
| Condition | Intervention |
|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Pain Precancerous Condition Psychosocial Effects of Cancer and Its Treatment |
Procedure: management of therapy complications Procedure: mind-body intervention procedure Procedure: music therapy Procedure: pain therapy Procedure: psychosocial assessment and care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | Use of Music to Reduce Anxiety & Perceived Pain for Adult Patients With Hematological Malignancies Undergoing Bone Marrow Biopsy |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2006 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, feasibility study. Patients are stratified according to the practitioner performing the procedure. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Suzanne C. Danhauer, PhD | Comprehensive Cancer Center of Wake Forest University |
More Information
| ClinicalTrials.gov Identifier: | NCT00376922 History of Changes |
| Other Study ID Numbers: | CDR0000495315, CCCWFU-98306, CCCWFU-IRB00000468 |
| Study First Received: | September 13, 2006 |
| Last Updated: | May 14, 2011 |
| Health Authority: | United States: Federal Government |
|
pain psychosocial effects of cancer and its treatment accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia chronic eosinophilic leukemia primary myelofibrosis chronic myelomonocytic leukemia chronic neutrophilic leukemia |
chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes essential thrombocythemia extramedullary plasmacytoma meningeal chronic myelogenous leukemia myelodysplastic/myeloproliferative neoplasm, unclassifiable polycythemia vera previously treated myelodysplastic syndromes primary systemic amyloidosis progressive hairy cell leukemia, initial treatment prolymphocytic leukemia secondary acute myeloid leukemia secondary myelodysplastic syndromes stage III adult T-cell leukemia/lymphoma stage III chronic lymphocytic leukemia |
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Neoplasms Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic |
Myelodysplastic-Myeloproliferative Diseases Pathologic Processes Neoplasms by Histologic Type Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases |