Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
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Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Procedure: music therapy Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized |
| Official Title: | Music Video and Adolescent/Young Adult Resilience During Transplant |
- Symptoms-related distress (pain, anxiety, fatigue, mucositis, sedation, and mood) at pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
- Uncertainty in illness as assessed by the Mishel Uncertainty in Illness Scale at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
- Use of defensive coping as assessed immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
- Use of positive coping as assessed immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
- Communication with family as assessed by Parent-Adolescent Communication at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
- Adaptability or cohesion as assessed by FACES II at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
- Perceived social support from friends, family, and healthcare providers at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
- Greater derived meaning from stem cell transplantation (STC) experience immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
- Higher resilience immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
- Quality of life at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
| Estimated Enrollment: | 130 |
| Study Start Date: | April 2006 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
- 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.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 11 Years to 24 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent therapy for pain control or relief of other symptoms allowed
Contacts and Locations| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Texas | |
| Methodist Children's Hospital of South Texas | |
| San Antonio, Texas, United States, 78229-3993 | |
| Study Chair: | Joan E. Haase, PhD, RN | Indiana University Melvin and Bren Simon Cancer Center |
| Investigator: | Sheri L. Robb, PhD | University of Missouri, Kansas City |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00305851 History of Changes |
| Other Study ID Numbers: | CDR0000463879, COG-ANUR0631 |
| Study First Received: | March 21, 2006 |
| Last Updated: | April 12, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
fatigue pain psychosocial effects of cancer and its treatment adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia, BCR-ABL1 negative blastic phase chronic myelogenous leukemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission |
childhood chronic myelogenous leukemia chronic eosinophilic leukemia primary myelofibrosis chronic myelomonocytic leukemia chronic neutrophilic leukemia chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes disseminated neuroblastoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue juvenile myelomonocytic leukemia myelodysplastic/myeloproliferative neoplasm, unclassifiable nodal marginal zone B-cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013