Bone Marrow TransplantNCT06361173
Spanish BMT4me Usability & Acceptability
An observational study of Bone Marrow Transplant, run by Nationwide Children's Hospital at 2 sites in United States.
Trial summary
The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Bone Marrow Transplant
- What is being tested?
- BMT4me
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Oct 2024to 24 Sep 2025
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will recruit 30 self-identified Spanish speaking primary caregivers of children post-HCT at two institutions.
Who may be able to join
- Eligible caregivers must have children who:
- Are 0-17 years old
- Underwent HCT
- Are planned for discharge prior to day 100 post-transplant
- Primary caregivers must:
- Be Spanish speaking
- Be ≥18 years old
- Have a smartphone (iOS or Android) capable of downloading apps
Who cannot join
- Children or caregivers with pre-existing neurodevelopmental disorder/disability or a pervasive developmental disorder will be excluded from this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nationwide Children's Hospital
Columbus, Ohio, 43215
Columbia University Irving Medical Center
New York, New York, 10027
About this study
The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Nationwide Children's Hospital (NCH) will be the primary data collection site and Columbia University Irving Medical Center will be a secondary site.
- Conditions
- Bone Marrow Transplant
- Being tested
- BMT4me
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMT4meOther
Caregivers will pilot test a Spanish version of the BMT4me app at a single time point.
| Study group | Role | What they receive |
|---|---|---|
| Spanish-speaking caregivers | Spanish-speaking caregivers recruited from Nationwide Children's Hospital and Columbia University Irving Medical Center to pilot test a Spanish a transcreated version of the BMT4me app Receives: Other: BMT4me |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess app usability using the System Usability Scale (SUS)
Data collected using the System Usability Scale (SUS) will provide insight to the usability of the Spanish BMT4Me app in its current form. he SUS is a 10-item questionnaire routinely used to evaluate the functionality and acceptability of mHealth apps. The SUS is scored on a scale, giving a score from from 0 to 100 where 100 is considered the highest rating of usability. A score of > 68 is considered above average.
Measured: 6/1/24 - 5/1/26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start9 Oct 2024
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow TransplantStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Micah Skeens, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361173
- Sponsor's protocol ID
- STUDY00004127
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2024
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data will be shared upon request.
Publications
Skeens MA, Peek MR, Franklin B, Sezgin E, Beauchemin M. BMT4me En Espanol: Multisite Feasibility and Usability Testing of a Spanish-Language mHealth Adherence Support App for Spanish-Speaking Caregivers of Children After Hematopoietic Stem Cell Transplantation and Cancer Treatment. Pediatr Blood Cancer. 2026 Sep;73(9):e70509. doi: 10.1002/1545-5017.70509. Epub 2026 Jul 23.
PubMed 42487535
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish BMT4me Usability & Acceptability
- ClinicalTrials.gov ID
- NCT06361173
- Acronym / sponsor ID
- STUDY00004127
- Conditions
- Bone Marrow Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 11 Apr 2024 (actual)
- 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.
The objective of this project is to trans-create, conduct user testing of a previously developed and piloted mHealth app, and user acceptability with parents of children in the acute phase post-allogeneic hematopoietic stem cell transplant (HSCT). Nationwide Children's Hospital (NCH) will be the primary data collection site and Columbia University Irving Medical Center will be a secondary site.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spanish-speaking caregivers | – | Other: BMT4meSpanish-speaking caregivers recruited from Nationwide Children's Hospital and Columbia University Irving Medical Center to pilot test a Spanish a transcreated version of the BMT4me app |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will recruit 30 self-identified Spanish speaking primary caregivers of children post-HCT at two institutions.
Key inclusion criteria (8 listed)
- Are 0-17 years old
- Underwent HCT
- Are planned for discharge prior to day 100 post-transplant
- Be Spanish speaking
- Be ≥18 years old
Key exclusion criteria (1 listed)
- Children or caregivers with pre-existing neurodevelopmental disorder/disability or a pervasive developmental disorder will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMT4meCaregivers will pilot test a Spanish version of the BMT4me app at a single time point. | Other | Spanish-speaking caregivers |
Primary outcome
Assess app usability using the System Usability Scale (SUS)
Time frame: 6/1/24 - 5/1/26
Data collected using the System Usability Scale (SUS) will provide insight to the usability of the Spanish BMT4Me app in its current form. he SUS is a 10-item questionnaire routinely used to evaluate the functionality and acceptability of mHealth apps. The SUS is scored on a scale, giving a score from from 0 to 100 where 100 is considered the highest rating of usability. A score of > 68 is considered above average.
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 4 Nov 2025.
- Derived from this study: PubMed 42487535Skeens MA, Peek MR, Franklin B, Sezgin E, Beauchemin M. BMT4me En Espanol: Multisite Feasibility and Usability Testing of a Spanish-Language mHealth Adherence Support App for Spanish-Speaking Caregivers of Children After Hematopoietic Stem Cell Transplantation and Cancer Treatment. Pediatr Blood Cancer. 2026 Sep;73(9):e70509. doi: 10.1002/1545-5017.70509. Epub 2026 Jul 23.
- Individual participant dataSharing planned: No. Aggregate data will be shared upon request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Transplant, run by Nationwide Children's Hospital at 2 sites 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 8 inclusion and 1 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 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 app usability using the System Usability Scale (SUS) (time frame: 6/1/24 - 5/1/26). 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 NCT06361173, which also lists 1 linked publication.
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 4 Nov 2025.