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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00305851 |
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Date of registration:
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21/03/2006 |
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Primary sponsor: |
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Public title:
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Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
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Scientific title:
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Music Video and Adolescent/Young Adult Resilience During Transplant |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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130 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00305851 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized
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Countries of recruitment
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United States
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Contacts
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Name:
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Joan E. Haase, PhD, RN |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indiana University Melvin and Bren Simon Cancer Center |
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Name:
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Sheri L. Robb, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Missouri, Kansas City |
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Key inclusion & exclusion criteria
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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
Age minimum:
11 Years
Age maximum:
24 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Procedure: music therapy
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Procedure: psychosocial assessment and care
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Procedure: quality-of-life assessment
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Primary Outcome(s)
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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
[Time Frame: No]
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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
[Time Frame: No]
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Use of defensive coping as assessed immediately after completion of study treatment, and 100 days post-transplant
[Time Frame: No]
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Use of positive coping as assessed immediately after completion of study treatment, and 100 days post-transplant
[Time Frame: No]
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Secondary Outcome(s)
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Adaptability or cohesion as assessed by FACES II at baseline, immediately after completion of study treatment, and 100 days post-transplant
[Time Frame: No]
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Communication with family as assessed by Parent-Adolescent Communication at baseline, immediately after completion of study treatment, and 100 days post-transplant
[Time Frame: No]
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Greater derived meaning from stem cell transplantation (STC) experience immediately after completion of study treatment, and 100 days post-transplant
[Time Frame: No]
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Higher resilience immediately after completion of study treatment, and 100 days post-transplant
[Time Frame: No]
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Perceived social support from friends, family, and healthcare providers at baseline, immediately after completion of study treatment, and 100 days post-transplant
[Time Frame: No]
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Quality of life at baseline, immediately after completion of study treatment, and 100 days post-transplant
[Time Frame: No]
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Secondary ID(s)
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CDR0000463879
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COG-ANUR0631
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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