NCT00645931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

5.4 years

First QC Date

March 25, 2008

Last Update Submit

May 31, 2023

Conditions

Psychological

Keywords

Bone MarrowBone Marrow TransplantPediatricPsychological ImpactPsychology

Outcome Measures

Primary Outcomes (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

    1 year post transplant

Secondary Outcomes (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

    1 year post transplant

Interventions

protein and calorie controlled diet and self-hypnotic relaxationBEHAVIORAL

daily

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients under the age of 18

You may qualify if:

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

You may not qualify if:

  • over the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Interventions

ProteinsCaloric Restriction

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and ProteinsDiet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Heather Hammerstrom, BA

    Helen DeVos Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

June 1, 2004

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

June 2, 2023

Record last verified: 2023-05

Locations

US(1)