Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014482
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-04-10
Brief Title:
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
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Music Therapy for Distress During Autologous Stem Cell Transplantation A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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-Hodgkins lymphoma vs Hodgkins lymphoma vs myelomaamyloidosis 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
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-Hodgkins lymphoma vs Hodgkins lymphoma vs myelomaamyloidosis 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1934 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068547 | REGISTRY | None | None |