Pilot Study of Educational Interventions in Pediatric Hematopoietic Stem Cell Donors to Increase Knowledge of Donation and Transplantation Procedures

May 4, 2020 updated by: National Cancer Institute (NCI)

Background:

  • Hematopoietic Stem Cell Transplant (HSCT) represents the second most frequent major organ transplant in the United States.
  • Pediatric 1st degree stem cell donors can experience a variety of psychological difficulties before and after donation with those who feel they are not adequately prepared for possible complications following stem cell donation and transplant describing negative emotions.
  • The importance of preparation for children undergoing medical procedures has long been recognized in the field of pediatric psychology

Objectives:

  • To assess how prepared pediatric donors are for stem cell donation by assessing their knowledge about stem cell transplants, and to assess their anxiety at different stages of the donation process.
  • To assess the effectiveness of a workbook and a board game as tools for conveying information on donation and transplantation to donors.
  • To identify donors who may require additional preparation before stem cell collection.
  • To explore the relationship between donor knowledge and anxiety symptoms.

Eligibility:

-Stem cell donors ages 10 to 26 years of age

Design:

  • Participant s baseline knowledge and anxiety are evaluated.
  • Participant s knowledge is reassessed and anxiety evaluated following an information session with the research nurse and doctor about the procedures for stem cell donation and discussion of the consent form for the transplant protocol.
  • Participants are separated into two groups. Donors 10 to 15 years of age play a board game; those 16 to 26 years of age are given a workbook on stem cell transplant.
  • Participants knowledge and anxiety are reassessed within 24 hours after working with the educational materials and again 1 month later.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Background:

  • Hematopoietic Stem Cell Transplant (HSCT) represents the second most frequent major organ transplant in the United States.
  • A variety of psychological difficulties in sibling donors post-stem cell donation are reported, including withdrawal, guilt, anger, depression, anxiety, mild to severe psychopathology, and post-traumatic stress symptomatology.
  • The importance of preparation for children undergoing medical procedures has long been recognized in the field of pediatric psychology. In previous research, siblings who felt they were not adequately prepared for possible complications following HSCT donation and transplant often described negative emotions.
  • Some siblings have reported feeling pressured and coerced to become a donor, while others describe a lack of attention to their physical fears associated with donation and their psychological concerns.
  • No prospective studies examining educational tools and transplant knowledge in sibling stem cell donors are currently available.

Objectives:

  • To assess pediatric 1st degree stem cell donor comprehension of transplant procedures and compare knowledge prior to educational interventions (pre and post-consent informational session) to knowledge following educational interventions.
  • To assess the effectiveness of a workbook intervention as a learning tool for conveying information on stem cell donation and transplantation to pediatric donors.
  • To assess the effectiveness of a board game intervention (ShopTalk) as a learning tool for conveying information on stem cell donation and transplantation to pediatric donors.
  • To identify donors who may require additional preparation prior to stem cell collection.
  • To measure donor anxiety pre and post the educational intervention and stem cell donation and explore the relationship between donor knowledge and anxiety symptoms.

Eligibility:

  • Age: 10 to 26 years of age
  • Participants or their parents must consent to participation in active bone marrow and peripheral blood stem cell transplant protocols at the NIH.
  • For donors less than 18 years of age, their legal guardian must give informed consent, the donor must give written assent.
  • For donors greater than or equal to 18 years of age, ability to give informed consent.
  • Participants must understand and read English or Spanish.

Design:

  • Baseline knowledge will be assessed following consent.
  • Knowledge will be reassessed following the information session for the transplant protocol
  • Donors will be stratified into 2 groups by age. Donors ages 10 to 15 will be scheduled the following day to play a game called ShopTalk. Donors ages 16 to 26 will be given a workbook on HSCT specifically designed for 1st degree stem cell donors. Knowledge will be reassessed following the administration of these interventions.
  • A follow-up assessment will be administered to all participants 1 month after the post intervention test was administered.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Description

  • INCLUSION CRITERIA:
  • Age: 10 to 26 years of age.
  • Participants or their parents must consent to participation in active bone marrow and peripheral blood stem cell transplant protocols at the NIH.
  • For donors less than 18 years of age, their legal guardian must give informed consent, the donor must give written assent.
  • For donors greater than or equal to 18 years of age, ability to give informed consent.
  • Participants must understand and read English or Spanish.

EXCLUSION CRITERIA:

  • Presence of psychiatric or psychological symptoms which in the judgment of the Principal or Associate Investigators would compromise the donor's ability to engage in the intervention or is likely to interfere with the study procedures or results.
  • Preciously identified cognitive impairment, which in the judgment of the Principal or Associate Investigators would compromise the donor's ability to understand the educational materials or the board game rules and procedures, and is likely to interfere with the study procedures or results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
1
bone marrow or stem cell donors ages 10 to 15
2
bone marrow or stem cell donors ages 16 to 26

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess 1st degree relative stem cell donor comprehension of transplant procedures
Time Frame: Prior to relatives transplant
results of donor quiz and anxiety assessment
Prior to relatives transplant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess efficacy of workbook intervention as a learning tool
Time Frame: Prior to relatives transplant
results of final quiz after workbook intervention
Prior to relatives transplant
Assess effectiveness of a board game as a learning tool
Time Frame: Prior to relatives transplant
results of final quiz after board game
Prior to relatives transplant
Measure donor anxiety pre-and post educational intervention and pre- and and post educational intervention and pre and post donation
Time Frame: Prior to relatives transplant
results of anxiety assessment, administered 1 month from initial post intervention test
Prior to relatives transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 070086
  • 07-C-0086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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