Trial Information
Music Video and Adolescent/Young Adult Resilience During Transplant
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Joan E. Haase, PhD, RN
Investigator Role:
Study Chair
Investigator Affiliation:
Indiana University Melvin and Bren Simon Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000463879
NCT ID:
NCT00305851
Start Date:
April 2006
Completion Date:
Related Keywords:
- Cancer
- 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
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- high risk metastatic gestational trophoblastic tumor
- previously treated childhood rhabdomyosarcoma
- previously treated myelodysplastic syndromes
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult Burkitt lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent childhood acute lymphoblastic leukemia
- recurrent childhood acute myeloid leukemia
- recurrent childhood large cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- recurrent childhood rhabdomyosarcoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- recurrent neuroblastoma
- recurrent ovarian epithelial cancer
- recurrent ovarian germ cell tumor
- recurrent small lymphocytic lymphoma
- recurrent malignant testicular germ cell tumor
- recurrent Wilms tumor and other childhood kidney tumors
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- secondary myelodysplastic syndromes
- splenic marginal zone lymphoma
- stage III adult Burkitt lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III chronic lymphocytic leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage III malignant testicular germ cell tumor
- stage IV adult Burkitt lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV chronic lymphocytic leukemia
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV ovarian epithelial cancer
- stage IV small lymphocytic lymphoma
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- childhood myelodysplastic syndromes
- Ewing sarcoma
- childhood brain tumor
- adult brain tumor
- osteosarcoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic