Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305851
Status:
COMPLETED
Last Update Posted:
2022-07-15
First Post:
2006-03-21
Brief Title:
Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Stories and Music for AdolescentYoung Adult Resilience During Transplant SMART
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This randomized phase III trial is studying how well music therapy works compared to listening and discussing books on tape in improving quality of life in young patients undergoing stem cell transplant Music therapy or book discussion may improve quality of life in patients undergoing stem cell transplant It is not yet known whether music therapy is more effective than book discussion in improving quality of life in patients undergoing stem cell transplant
Detailed Description:
PRIMARY OBJECTIVES
I Test the efficacy in terms of resilience and quality of life of a therapeutic music video TMV intervention vs listening and discussing books on tape control group for adolescents and young adults AYA undergoing autologous or allogeneic transplantation for cancer
II Qualitatively describe the perception of helpfulness and meaningfulness of a sub-group of both interventions for AYA and family members 100 days post-transplant
OUTLINE This is a randomized controlled limited multicenter study Patients are randomized to 1 of 2 arms
ARM I books on tape control group Patients undergo six 1-hour sessions twice a week for 3 weeks with a trained counselor in which they choose up to 3 books on CD and listen to the book andor discuss their impressions and thoughts about the contents with the counselor Patients are provided with a portable CD player to listen to the books during their hospitalization
ARM II therapeutic music video TMV intervention Patients undergo six 1-hour sessions twice a week for 3 weeks with a music therapist designed specifically for the pre-transplant and acute phase of treatment Phases of patient participation include song writing recording the song with a digital accompaniment track completing a video layout worksheet taking photos or making drawings for the video viewing clip art and pictures on a computer and sharing the final video with family members and hospital staff
In both arms patients complete questionnaires before and after sessions 2 4 and 6 with the music therapist Patients also complete computer-based questionnaires before hospitalization after session six during hospitalization and at 100 days post-transplantation
I Test the efficacy in terms of resilience and quality of life of a therapeutic music video TMV intervention vs listening and discussing books on tape control group for adolescents and young adults AYA undergoing autologous or allogeneic transplantation for cancer
II Qualitatively describe the perception of helpfulness and meaningfulness of a sub-group of both interventions for AYA and family members 100 days post-transplant
OUTLINE This is a randomized controlled limited multicenter study Patients are randomized to 1 of 2 arms
ARM I books on tape control group Patients undergo six 1-hour sessions twice a week for 3 weeks with a trained counselor in which they choose up to 3 books on CD and listen to the book andor discuss their impressions and thoughts about the contents with the counselor Patients are provided with a portable CD player to listen to the books during their hospitalization
ARM II therapeutic music video TMV intervention Patients undergo six 1-hour sessions twice a week for 3 weeks with a music therapist designed specifically for the pre-transplant and acute phase of treatment Phases of patient participation include song writing recording the song with a digital accompaniment track completing a video layout worksheet taking photos or making drawings for the video viewing clip art and pictures on a computer and sharing the final video with family members and hospital staff
In both arms patients complete questionnaires before and after sessions 2 4 and 6 with the music therapist Patients also complete computer-based questionnaires before hospitalization after session six during hospitalization and at 100 days post-transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-00408 | REGISTRY | None | None |
| CDR0000463879 | None | None | None |
| COG-ANUR0631 | OTHER | None | None |
| COG-ANUR0631 | OTHER | None | None |
| ANUR0631 | OTHER | None | None |
| R01NR008583 | NIH | None | None |
| U10CA095861 | NIH | CTEP | httpsreporternihgovquickSearchU10CA095861 |