World Health Organization site
Skip Navigation Links

Main
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.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00305851
Date of registration: 21/03/2006
Primary sponsor: Children's Oncology Group
Public title: Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
Scientific title: Music Video and Adolescent/Young Adult Resilience During Transplant
Date of first enrolment: April 2006
Target sample size: 130
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00305851
Study type:  Interventional
Study design:  Allocation: Randomized  
Countries of recruitment
United States
Contacts
Name:   Joan E. Haase, PhD, RN
Address: 
Telephone:
Email:
Affiliation:  Indiana University Melvin and Bren Simon Cancer Center
Name:   Sheri L. Robb, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Missouri, Kansas City
Key inclusion & exclusion 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



Age minimum: 11 Years
Age maximum: 24 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Cancer
Intervention(s)
Procedure: music therapy
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Primary Outcome(s)
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]
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]
Use of defensive coping as assessed immediately after completion of study treatment, and 100 days post-transplant [Time Frame: No]
Use of positive coping as assessed immediately after completion of study treatment, and 100 days post-transplant [Time Frame: No]
Secondary Outcome(s)
Adaptability or cohesion as assessed by FACES II at baseline, immediately after completion of study treatment, and 100 days post-transplant [Time Frame: No]
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]
Greater derived meaning from stem cell transplantation (STC) experience immediately after completion of study treatment, and 100 days post-transplant [Time Frame: No]
Higher resilience immediately after completion of study treatment, and 100 days post-transplant [Time Frame: No]
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]
Quality of life at baseline, immediately after completion of study treatment, and 100 days post-transplant [Time Frame: No]
Secondary ID(s)
CDR0000463879
COG-ANUR0631
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history