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

Children's Oncology Group

Status and phase: Completed; Phase 3

Conditions: Malignant Neoplasm

Treatments: Other: Quality-of-Life Assessment; Procedure: Psychosocial Assessment and Care; Procedure: Music Therapy

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00305851

R01NR008583 (U.S. NIH Grant/Contract)

CDR0000463879

COG-ANUR0631 (Other Identifier)

ANUR0631

NCI-2009-00408 (Other Identifier)

U10CA095861 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 11 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Arm I (counseling)

Active Comparator group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Procedure: Psychosocial Assessment and Care

Arm II (counseling and music therapy)

Experimental group

Description:

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.

Treatment:

Procedure: Music Therapy

Other: Quality-of-Life Assessment

Procedure: Psychosocial Assessment and Care