Testing the Effectiveness of Child and Parent-Targeted Health Promotion Interventions in Pediatric Stem Cell Transplantation

Not Applicable

Completed

• Conditions: Bone Marrow; Stem Cell Transplant
• Interventions: Other: Massage Therapy; Other: Humor Therapy; Other: Relaxation Therapy

• Registration Number: NCT00760227
• Lead Sponsor: St. Jude Children's Research Hospital

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.

Detailed Description

Treatment Plan: Interventions involve 3 components, Massage Therapy, Humor Therapy, and Relaxation Therapy, as described below:

Massage Therapy 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.

Humor Therapy For this component will utilize a humor cart, stocked with humorous video shorts, books, gags, props and games.

Relaxation Therapy 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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2007-12
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-27
• Last Update Posted: 2011-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1: HPI-C	Massage Therapy	Child Intervention Only Group
1: HPI-C	Humor Therapy	Child Intervention Only Group
2: HPI-CP	Massage Therapy	Parent and Child Intervention Group
2: HPI-CP	Relaxation Therapy	Parent and Child Intervention Group

Primary Outcome Measures

Name	Time	Method
To test the effectiveness of the health-promotion interventions in improving patient and parent well-being during the acute phase of BMT.	6 weeks

Trial Locations

Locations (4)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Columbus Children's Research Institute; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States