Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT00305851
Status:
COMPLETED
Last Update Posted:
2022-07-15
First Post:
2006-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
Sponsor:
Children's Oncology Group
Organization:
Study Overview
Official Title:
Stories and Music for Adolescent/Young 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 and/or 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 and/or 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:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00408 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000463879 | None | None | View | |
| COG-ANUR0631 | OTHER | Children's Oncology Group | View | |
| COG-ANUR0631 | OTHER | DCP | View | |
| ANUR0631 | OTHER | CTEP | View | |
| R01NR008583 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA095861 | NIH | None | https://reporter.nih.gov/quic… | View |