Clinical trial NCT00305851: Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
Official title: Stories and Music for Adolescent/Young Adult Resilience During Transplant (SMART)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Neoplasm
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: National Institute of Nursing Research (NINR)
First posted: 2006-03-22
Enrollment: 118
Sex: ALL
Minimum age (years): 11
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Assess acute changes of Symptoms-related distress: Pain
timeFrame: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess acute changes of Symptoms-related distress: Anxiety
timeFrame: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess acute changes of Symptoms-related distress: Fatigue
timeFrame: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess acute changes of Symptoms-related distress: Mood
timeFrame: Change from pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess changes in uncertainty in illness as assessed by the Mishel Uncertainty in Illness Scale
timeFrame: Change from baseline, immediately after completion of study treatment and 100 days post-transplant
measure: Assess changes in the use of defensive coping
timeFrame: Change from immediately after completion of study treatment and 100 days post-transplant
measure: Assess changes in the use of positive coping
timeFrame: Change from immediately after completion of study treatment and 100 days post-transplant
measure: Assess changes in communication with family as assessed by Parent-Adolescent Communication
timeFrame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess changes in adaptability or cohesion as assessed by FACES II
timeFrame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess changes in perceived social support from friends
timeFrame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess changes in perceived social support from family
timeFrame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess changes in perceived social support from healthcare providers
timeFrame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess changes in Hope from stem cell transplantation (STC) experience:
timeFrame: Change from immediately after completion of study treatment, and 100 days post-transplant
measure: Assess changes in Spiritual Perspective from stem cell transplantation (STC) experience
timeFrame: Change from immediately after completion of study treatment, and 100 days post-transplant
measure: Assess changes of Higher Resilience: Haase Adolescent Resilience in Cancer Scale
timeFrame: Change from after completion of study treatment and 100 days post-transplant
measure: Assess changes of Higher Resilience (self esteem, confidence, self-transcendence): NCS
timeFrame: Change from after completion of study treatment, and 100 days post-transplant
measure: Assess changes of Higher Resilience (self esteem, confidence, self-transcendence): STS
timeFrame: Change from after completion of study treatment, and 100 days post-transplant
measure: Assess changes in Higher Resilience (self esteem, confidence, self-transcendence): SES
timeFrame: Change from after completion of study treatment, and 100 days post-transplant
measure: Assess changes in indicators of well-being and global quality of life: LASA Uniscale
timeFrame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
measure: Assess changes in indicators of well-being and global quality of life: IWB
timeFrame: Change from baseline, immediately after completion of study treatment, and 100 days post-transplant
Secondary outcomes:
measure: Qualitatively describe the perception of helpfulness and meaningfulness of both the low-dose and TMV interventions for AYA and family members
timeFrame: 100 days post-transplant
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Egleston
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Philadelphia
country: United States
facility: Children's Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Joan E Haase
role: PRINCIPAL_INVESTIGATOR
References: