Normal DonorsNCT01445158
Pilot Study of Educational Interventions in Pediatric Hematopoietic Stem Cell Donors to Increase Knowledge of Donation and Transplantation Procedures
An observational study of Normal Donors, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 26 years
- Conditions the study is for
- Normal Donors
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2007to 4 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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
Read more
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.
Read the 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.
- Conditions
- Normal Donors
- Keywords
- ShopTalk, Comprehension, Donors, Education, Stem Cell Transplant, Sibling Donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | bone marrow or stem cell donors ages 10 to 15 | |
| 2 | bone marrow or stem cell donors ages 16 to 26 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess 1st degree relative stem cell donor comprehension of transplant procedures
results of donor quiz and anxiety assessment
Measured: Prior to relatives transplant
Secondary outcomes (3)
Assess efficacy of workbook intervention as a learning tool
results of final quiz after workbook intervention
Measured: Prior to relatives transplant
Assess effectiveness of a board game as a learning tool
results of final quiz after board game
Measured: Prior to relatives transplant
Measure donor anxiety pre-and post educational intervention and pre- and and post educational intervention and pre and post donation
results of anxiety assessment, administered 1 month from initial post intervention test
Measured: Prior to relatives transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study start18 Jun 2007
- Primary completion20 Sep 2017
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Normal DonorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lori Wiener, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445158
- Sponsor's protocol ID
- 070086
- Other IDs
- 07-C-0086
- Status last verified
- May 2020
- First submitted
- 30 Sep 2011
- Last updated
- 5 May 2020
- Results posted
- No
Publications
Lipton JM. Peripheral blood as a stem cell source for hematopoietic cell transplantation in children: is the effort in vein? Pediatr Transplant. 2003;7 Suppl 3:65-70. doi: 10.1034/j.1399-3046.7.s3.10.x.
PubMed 12603696Grupp SA, Frangoul H, Wall D, Pulsipher MA, Levine JE, Schultz KR. Use of G-CSF in matched sibling donor pediatric allogeneic transplantation: a consensus statement from the Children's Oncology Group (COG) Transplant Discipline Committee and Pediatric Blood and Marrow Transplant Consortium (PBMTC) Executive Committee. Pediatr Blood Cancer. 2006 Apr;46(4):414-21. doi: 10.1002/pbc.20800.
PubMed 16463346Wiley FM, Lindamood MM, Pfefferbaum-Levine B. Donor-patient relationship in pediatric bone marrow transplantation. J Assoc Pediatr Oncol Nurses. 1984 Summer;1(3):8-14. doi: 10.1177/104345428400100304. No abstract available.
PubMed 6381691
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Educational Interventions in Pediatric Hematopoietic Stem Cell Donors to Increase Knowledge of Donation and Transplantation Procedures
- ClinicalTrials.gov ID
- NCT01445158
- Acronym / sponsor ID
- 070086
- Conditions
- Normal Donors
- Keywords
- ShopTalk, Comprehension, Donors, Education, Stem Cell Transplant, Sibling Donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 18 Jun 2007 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –bone marrow or stem cell donors ages 10 to 15 |
| 2 | – | –bone marrow or stem cell donors ages 16 to 26 |
Who may qualify
- Ages
- 10 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess 1st degree relative stem cell donor comprehension of transplant procedures
Time frame: Prior to relatives transplant
results of donor quiz and anxiety assessment
3 secondary outcomes
Assess efficacy of workbook intervention as a learning tool
Time frame: Prior to relatives transplant
Assess effectiveness of a board game as a learning tool
Time frame: 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 and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Background: PubMed 12603696Lipton JM. Peripheral blood as a stem cell source for hematopoietic cell transplantation in children: is the effort in vein? Pediatr Transplant. 2003;7 Suppl 3:65-70. doi: 10.1034/j.1399-3046.7.s3.10.x.
- Background: PubMed 16463346Grupp SA, Frangoul H, Wall D, Pulsipher MA, Levine JE, Schultz KR. Use of G-CSF in matched sibling donor pediatric allogeneic transplantation: a consensus statement from the Children's Oncology Group (COG) Transplant Discipline Committee and Pediatric Blood and Marrow Transplant Consortium (PBMTC) Executive Committee. Pediatr Blood Cancer. 2006 Apr;46(4):414-21. doi: 10.1002/pbc.20800.
- Background: PubMed 6381691Wiley FM, Lindamood MM, Pfefferbaum-Levine B. Donor-patient relationship in pediatric bone marrow transplantation. J Assoc Pediatr Oncol Nurses. 1984 Summer;1(3):8-14. doi: 10.1177/104345428400100304. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Wiener, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Donors, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess 1st degree relative stem cell donor comprehension of transplant procedures (time frame: Prior to relatives transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445158, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.