Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant

NCT ID: NCT00305851

Last Updated: 2022-07-15

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

PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-15

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (counseling)

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.

Group Type ACTIVE_COMPARATOR

Psychosocial Assessment and Care

Intervention Type PROCEDURE

Undergo books on tape therapy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Arm II (counseling and music therapy)

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.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type PROCEDURE

Undergo therapeutic music video therapy

Psychosocial Assessment and Care

Intervention Type PROCEDURE

Undergo books on tape therapy

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Music Therapy

Undergo therapeutic music video therapy

Intervention Type PROCEDURE

Psychosocial Assessment and Care

Undergo books on tape therapy

Intervention Type PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Psychosocial Care/Assessment Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of an oncology condition requiring allogeneic or autologous transplantation
* Receiving or planning to receive a myeloablative treatment regimen and 1 of the following:

* Marrow transplantation
* Peripheral stem cell transplantation
* Cord blood stem cell transplantation
* Patients with cancers that do not usually occur in childhood/adolescent or young adult populations (e.g., breast or prostate cancer) are not eligible
* Able to read and speak English

* English does not need to be the primary language
* Able to participate in the sessions as evaluated for alertness and engagement by the music therapist
* No cognitive impairments that would make it difficult to participate in the intervention or complete questionnaires
* Not married and not a parent
* Concurrent therapy for pain control or relief of other symptoms allowed
Minimum Eligible Age

11 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan E Haase

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, United States

Site Status

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status

Children's Oncology Group

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2009-00408

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000463879

Identifier Type: -

Identifier Source: secondary_id

COG-ANUR0631

Identifier Type: OTHER

Identifier Source: secondary_id

COG-ANUR0631

Identifier Type: OTHER

Identifier Source: secondary_id

ANUR0631

Identifier Type: OTHER

Identifier Source: secondary_id

R01NR008583

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA095861

Identifier Type: NIH

Identifier Source: secondary_id

View Link

COG-ANUR0631

Identifier Type: -

Identifier Source: org_study_id

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