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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00760227
Other study ID # HOBIT3
Secondary ID
Status Completed
Phase N/A
First received September 25, 2008
Last updated September 27, 2011
Start date January 2003

Study information

Verified date September 2011
Source St. Jude Children's Research Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
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 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.

Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario
United States Columbus Children's Research Institute Columbus Ohio
United States St. Jude Children's Research Hospital Memphis Tennessee
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
St. Jude Children's Research Hospital

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To test the effectiveness of the health-promotion interventions in improving patient and parent well-being during the acute phase of BMT. 6 weeks No
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