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Psychological Effects of Bone Marrow Transplants in Children

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ClinicalTrials.gov Identifier: NCT00645931
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : December 30, 2009
Sponsor:
Collaborator:
Helen DeVos Children's Hospital
Information provided by:
Spectrum Health Hospitals

Brief Summary:
This study is designed to examine the psychological effects of bone marrow transplants on children and their families. The investigators hypothesis is that families who show signs of psychological distress before transplant will continue those signs post transplant. The investigators are examining cognitive placement, emotional placement and other psychological factors in both the child undergoing transplant and his or her parent.

Condition or disease Intervention/treatment
Psychological Behavioral: protein and calorie controlled diet and self-hypnotic relaxation

Detailed Description:
Previous research on bone marrow transplants has conflicting results concerning the effects of maladjustment. The current research is conducted in consortium with DeVos Children's Hospital. Children receiving bone marrow transplants are assessed using the Child Behavior Check List (CBCL) and Cognitive based testing. Parents are assessed using the Parenting Stress Index (PSI). Children and parents are evaluated prior to transplant and then 50 days, 6 months, and one year post transplant. Descriptive statistics are currently being used to determine results.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Proposal for a Bone Marrow Transplant Pre, Post, and Long Term Psychological Evaluation Study.
Study Start Date : June 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: protein and calorie controlled diet and self-hypnotic relaxation
    daily


Primary Outcome Measures :
  1. The specific measure that will be used to determine the effect of the intervention(s). The description should included the time at which the measure will be taken. Examples: all cause mortality at one year; score on a depression rating scale at 6 weeks [ Time Frame: 1 year post transplant ]

Secondary Outcome Measures :
  1. Other measures that will be used to evaluate the intervention(s), and that are specified in the protocol. The description should include the time at which the measures will be taken. Ex. cardiovascular mortality at 6 mos.; functional status at 4 wks [ Time Frame: 1 year post transplant ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients under the age of 18
Criteria

Inclusion Criteria:

  • bone marrow transplant eligible patients
  • 18 years and under
  • male and female

Exclusion Criteria:

  • over the age of 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645931


Locations
United States, Michigan
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Helen DeVos Children's Hospital
Investigators
Principal Investigator: Heather Hammerstrom, BA Helen DeVos Children's Hospital

Responsible Party: Heather L Hammerstrom, Spectrum Health
ClinicalTrials.gov Identifier: NCT00645931     History of Changes
Other Study ID Numbers: 2004-105
2004-105
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: December 30, 2009
Last Verified: December 2009

Keywords provided by Spectrum Health Hospitals:
Bone Marrow
Bone Marrow Transplant
Pediatric
Psychological Impact
Psychology

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs