Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04400071
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2020-05-15
Brief Title:
Biology and Benefits of Music Play and Stories for KidsParents During ALL Treatment
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Biologic Mechanisms and Dosing of Active Music Engagement in Children With Acute Lymphoblastic Leukemia and Parents
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Music therapy has become a standard palliative care service in many pediatric and adult hospitals however a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health without considering biological dimensions This study builds on prior work examining the psychosocial mechanisms of action underlying an Active Music Engagement AME intervention designed to help manage emotional distress and improve positive health outcomes in young children with cancer and parents by examining its effects on biomarkers of stress and immune function The purposes of this two group randomized controlled trial are to examine biological mechanisms of effect and dose-response relationships of AME on childparent stress during the consolidation phase of Acute Lymphoblastic Leukemia ALL treatment Specific aims are to Aim 1 Establish whether AME lowers child and parent cortisol during ALL treatment Aim 2 Examine cortisol as a mediator of AME effects on child and parent outcomes during ALL treatment Aim 3 exploratory Examine the dose-response relationship of AME on child and parent cortisol during ALL treatment Findings will provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function with direct implications for the evidence-based use of music to improve health
Detailed Description:
Music therapy has become a standard palliative care service in many pediatric and adult hospitals However a majority of music therapy research has focused on the use of music to improve psychosocial dimensions of health without considering biological dimensions In addition few studies have examined dose-response relationships Cancer treatment is an inherently stressful experience and a significant number of young children and parents caregivers experience persistent interrelated emotional distress and poor quality of life Many parents also experience traumatic stress symptoms because of their childs cancer diagnosis and treatment The investigators previously tested an Active Music Engagement AME intervention that uses active music play to diminish stressful attributes of cancer treatment to help manage emotionaltraumatic distress experienced by young children ages 3-8 and parents and improve quality of life A recent AME trial is examining psychosocial mechanisms of action responsible for change in childparent outcomes The current study expands on this work by examining AMEs effects on several biomarkers to provide a more holistic understanding about how active music interventions work to mitigate cancer-related stress and its potential to improve immune function The purposes of this two group randomized controlled trial are to examine biological mechanisms of effect and dose-response relationships of AME on childparent stress during the consolidation phase of Acute Lymphoblastic Leukemia ALL treatment Specific aims are to 1 establish whether AME lowers child and parent cortisol 2 examine cortisol as a mediator of AME effects on child and parent outcomes and 3 examine the dose-response relationship of AME on child and parent cortisol Childparent dyads n250 will be stratified by age site ALL risk level and randomized in blocks of four to AME or attention control Each group will receive one 45-minute session during weekly clinic visits for the duration of ALL consolidation 4 weeks standard risk 8 weeks high risk Parents will complete measures at baseline and following the last study session Child and parent salivary cortisol samples will be taken pre and post-session for the first 4 AME or attention control sessions Child blood samples will be reserved from routine blood draws prior to sessions 1 and 4 all participants and session 8 high risk participants Linear mixed models will be used to estimate AMEs effect on child and parent cortisol Examining child and parent cortisol as mediators of AME effects on child and parent outcomes will be performed in an ANCOVA setting fitting the appropriate mediation models using MPlus and then testing indirect effects using the percentile bootstrap approach to estimate the indirect effect Graphical plots and non-linear repeated measures models will be used to examine the dose-response relationship of AME on child and parent cortisol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NR019190 | NIH | None | httpsreporternihgovquickSearchR01NR019190 |