Testing the Effectiveness of Child and Parent-Targeted Health Promotion Interventions in Pediatric Stem Cell Transplantation
1 other identifier
interventional
189
2 countries
4
Brief Summary
The overall aim of the proposed project is to evaluate the impact of a health promotion intervention for children undergoing bone marrow or stem cell transplant (BMT). The intervention is complementary in nature, designed to increase the experience of positive affect and reduce somatic distress and mood disturbance, that is, to improve overall child well-being. The study will utilize a positive psychology model, exploring the hypothesis that improved outcomes will be mediated by the increased experience of positive affect states brought about by the intervention. The primary focus is on a child-targeted intervention that includes massage therapy and humor therapy. The study will also assess whether the addition of a similar parent-targeted intervention involving massage therapy and relaxation training will provide significant benefits beyond those provided by the child-targeted intervention alone. The study will utilize a 3-group design, with participants randomized to receive:1) a child-targeted intervention (HPI-C); 2) a child targeted intervention plus a parent-targeted intervention (HPI-CP); 3) standard care (SC). Primary outcomes include child positive affect, somatic distress and mood disturbance, as well as measures of parental positive affect and distress. Additional objectives of the study include examining the impact of the intervention on short-term medical outcomes, as well as measures of child health-related quality of life and parent and child post-traumatic stress symptoms (PTSS) at 6 months post-BMT. Analyses will explore hypotheses specific to the positive psychology model, testing the role of positive affect and dispositional optimism as mediators and moderators of the intervention on child and parent well-being. We will also obtain pilot data examining the effect of the interventions on neuroendocrine and neuroimmune markers of stress.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedSeptember 29, 2011
September 1, 2011
4.9 years
September 25, 2008
September 27, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To test the effectiveness of the health-promotion interventions in improving patient and parent well-being during the acute phase of BMT.
6 weeks
Study Arms (3)
1: HPI-C
OTHERChild Intervention Only Group
2: HPI-CP
OTHERParent and Child Intervention Group
3: SC
NO INTERVENTIONStandard Care Control Group- No Intervention
Interventions
Patient and parents will meet with a licensed massage therapist at the time of admission. During the session, the therapist will introduce them to the rationale of the massage intervention before moving on to provide the initial massage session. Each session will last approximately 1/2 hour. Massage sessions will be scheduled 3x/week from admission through week +3.
For this component will will utilize a humor cart, stocked with humorous video shorts, books, gags, props and games.
In the initial session held near the time of admission, parents will meet with the RA therapist, who will describe relaxation response and the benefits of a regular practice of relaxation techniques. They will be led through a modified progressive muscle relaxation induction, using breath awareness and muscle release, followed by guided imagery.
Eligibility Criteria
You may qualify if:
- For Child Participants:
- Age 6-18 years inclusive.
- Scheduled to undergo allogeneic or autologous stem cell transplant.
- Anticipated hospital stay of at least 3 weeks.
- English speaking
- For Resident Parent Participants:
- Parent speaks and reads English.
- Parent will be a primary caregiver for child during BMT.
- Parent will be available for the duration of transplant hospitalization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Columbus Children's Research Institute
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
The Hospital for Sick Children
Toronto, Ontario, M5G, Canada
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Phipps, PhD
St. Jude Children's Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 26, 2008
Study Start
January 1, 2003
Primary Completion
December 1, 2007
Last Updated
September 29, 2011
Record last verified: 2011-09