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NCT00760227 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
NA
Development phase
189
Enrollment target

NCT00760227: Completed NA study, sponsored by St. Jude Children's Research Hospital.

NCT00760227 is a NA study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 189 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00760227, a NA study, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
NA
Development phase
189 participants
Enrollment target

Study 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.

Interventions

  • OTHER Massage Therapy
  • OTHER Humor Therapy
  • OTHER Relaxation Therapy

Trial Details

FieldValue
Enrollment Target 189 participants
Start Date 2003-01
Phase NA

What the finished NCT00760227 record still lists

NCT00760227 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 3 interventions - of which Massage Therapy is the first listed.

NCT00760227 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00760227 about?

NCT00760227 is a clinical study titled "Testing the Effectiveness of Child and Parent-Targeted Health Promotion Interventions in Pediatric Stem Cell Transplantation". 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 ...

What is the current status of trial NCT00760227?

This trial is currently completed. It is a NA study. The enrollment target is 189 participants. The study started on 2003-01.

What interventions are being tested in trial NCT00760227?

The interventions under investigation include: Massage Therapy (OTHER), Humor Therapy (OTHER), Relaxation Therapy (OTHER).

Who is sponsoring clinical trial NCT00760227?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00760227's enrollment target sits among peer trials

189 576th of 2000 higher than 1,425 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00760227, the US trial registry maintained by the National Library of Medicine. NCT00760227 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.