Testing the Effectiveness of Child and Parent-Targeted Health Promotion Interventions in Pediatric Stem Cell Transplantation
Condition: Bone Marrow; Stem Cell Transplant
Study type: Interventional

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.
    

Intervention name(s): Massage Therapy; Humor Therapy; Relaxation Therapy
Intervention type(s): Other; Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)