Psychological Effects of Bone Marrow Transplants in Children - Full Text View

Sponsors and Collaborators:	Spectrum Health Hospitals Helen DeVos Children's Hospital
Information provided by:	Spectrum Health Hospitals
ClinicalTrials.gov Identifier:	NCT00645931

Purpose

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

Condition	Intervention
Psychological	Behavioral: protein and calorie controlled diet and self-hypnotic relaxation

MedlinePlus related topics: Bone Marrow Transplantation Diets

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Proposal for a Bone Marrow Transplant Pre, Post, and Long Term Psychological Evaluation Study.

Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2004
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Intervention Details:

daily

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.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645931

Contacts

Contact: Heather Hammerstrom

616-391-2158

Heather.Hammerstrom@spectrum-health.org

Locations

United States, Michigan
Helen DeVos Children's Hospital	Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Heather Hammerstrom, BA
Sub-Investigator: Steven Pastrynak, Ph.D.

Sponsors and Collaborators

Spectrum Health Hospitals

Helen DeVos Children's Hospital

Investigators

Principal Investigator:

Heather Hammerstrom, BA

Helen DeVos Children's Hospital

More Information

No publications provided

Responsible Party:	Spectrum Health ( Heather L Hammerstrom )
Study ID Numbers:	2004-105, 2004-105
Study First Received:	March 25, 2008
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00645931 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Spectrum Health Hospitals:

Bone Marrow, Bone Marrow Transplant, Pediatric, Psychological Impact, Psychology

Study placed in the following topic categories:

Hypnotics and Sedatives
Central Nervous System Depressants

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Hypnotics and Sedatives

Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009