Patients Undergoing Bone Marrow Transplant (BMT)NCT03161665
Patient and Caregiver Participation Through an Educational Health Information Technology System ("BMT Roadmap") in the Context of Hematopoietic Cell Transplantation
A study testing BMT Roadmap in people with Patients Undergoing Bone Marrow Transplant (BMT), run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow transplantation (BMT), is a potentially life-saving therapy for many malignant and non-malignant conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Bone Marrow Transplant (BMT)
- What is being tested?
- BMT Roadmap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2016to 6 Jan 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be recruited by BMT RN Coordinators and physicians prior to patient admission to the BMT Unit. Caregiver (age 18 years or older) of any patient eligible to undergo autologous or allogeneic BMT and any patient (age 18 years or older) eligible to undergo autologous or allogeneic BMT will be recruited during the "Pre-Transplant Work-up" stage in the outpatient setting.
- CAREGIVER PARTICIPANTS: Caregiver (age 18 years or older) of a patient who will be hospitalized to undergo first-time autologous (self) or allogeneic (alternative donor) BMT in the University of Michigan Mott Children's Hospital BMT Unit
- PATIENT PARTICIPANTS: Patients (age 18 years or older) who will be hospitalized to undergo first-time autologous or allogeneic BMT will be given the opportunity to assent/consent and participate in the study. With his/her permission, the patient will also be provided with their own iPad® BMT Roadmap information system to use. Qualitative interviews will be conducted in patients with their assent/consent.
- Ability to speak and read proficiently in English (the study's instruments have not been translated and validated in languages other than English)
- Willing and able to provide informed consent
- Willing to comply with study procedures and reporting requirements
Who cannot join
- Not willing and able to provide informed consent
- Not willing to comply with study procedures and reporting requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: A Pilot Study of Patient and Caregiver Participation Through an Educational Health Information Technology System ("BMT Roadmap") in the Context of Hematopoietic Cell Transplantation (Adult Protocol)
Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow transplantation (BMT), is a potentially life-saving therapy for many malignant and non-malignant conditions. Despite advances over the past decade, which have led to improved outcomes, BMT remains an intense treatment modality often requiring prolonged inpatient--based care. While many patients endure the acute complications of the procedure, it is common for BMT patients and their caregivers to experience increased risk of financial and emotional burden, hospital readmission, and health service utilization. This highlights the importance of active involvement of BMT patients in their own health care (self--efficacy).
Given the intense nature of BMT, however, caregivers also play a critical role in the process and are a necessary component of proceeding with transplant. As such, caregiver activation on behalf of the patient plays a critical role in effective patient--caregiver-provider partnerships, which is increasingly recognized as the optimal model for health care delivery, particularly for those facing life--altering medical treatments. It is essential to develop effective strategies to enhance this partnership. Health information technology (IT)-mediated tools offer the potential to overcome constraints in health care delivery limited by provider time, complicated health information, and financial pressures. Significant gaps in knowledge exist on the use of health IT tools using low- cost and well- accepted delivery platforms in routine inpatient care, especially for high- risk or critically ill populations. We hypothesize that a tablet--based tool displaying personal health information could provide a platform to promote caregiver activation and enhance health communication.
- Being tested
- BMT Roadmap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMT RoadmapOther
The BMT Roadmap is a health IT System that has been developed for use on the Apple iPad® to give the patient and caregivers easy access to test results, current treatment and contact information to hopefully increase active participation and engagement in transplant care.
| Study group | Role | What they receive |
|---|---|---|
| BMT Roadmap | Experimental | The BMT Roadmap information system will be tested in 20 caregivers of patients undergoing autologous or allogeneic BMT and in 20 patients undergoing autologous or allogeneic BMT. Receives: Other: BMT Roadmap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Caregivers Accrued
Feasibility of the study will be determined by demonstrating that accruing at least 20% of caregivers from the BMT patient population is possible.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start14 Jan 2016
- Primary completion6 Jan 2017
- Study completion6 Jan 2017
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 Patients Undergoing Bone Marrow Transplant (BMT)Studies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The BMT Roadmap information system will be tested in 20 caregivers of patients undergoing autologous or allogeneic BMT and 20 patients undergoing autologous or allogeneic BMT.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung Choi, M.D., M.S., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161665
- Sponsor's protocol ID
- UMCC 2015.140
- Other IDs
- HUM00107014
- Status last verified
- Nov 2017
- First submitted
- 18 May 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fauer AJ, Hoodin F, Lalonde L, Errickson J, Runaas L, Churay T, Seyedsalehi S, Warfield C, Chappell G, Brookshire K, Chaar D, Shin JY, Byrd M, Magenau J, Hanauer DA, Choi SW. Impact of a health information technology tool addressing information needs of caregivers of adult and pediatric hematopoietic stem cell transplantation patients. Support Care Cancer. 2019 Jun;27(6):2103-2112. doi: 10.1007/s00520-018-4450-4. Epub 2018 Sep 20.
PubMed 30232587
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Patient and Caregiver Participation Through an Educational Health Information Technology System ("BMT Roadmap") in the Context of Hematopoietic Cell Transplantation (Adult Protocol)
- ClinicalTrials.gov ID
- NCT03161665
- Acronym / sponsor ID
- UMCC 2015.140
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 6 Jan 2017 (actual)
- Study completion
- 6 Jan 2017 (actual)
- First posted
- 22 May 2017 (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.
Hematopoietic cell transplantation (BMT), or commonly referred to as blood and marrow transplantation (BMT), is a potentially life-saving therapy for many malignant and non-malignant conditions. Despite advances over the past decade, which have led to improved outcomes, BMT remains an intense treatment modality often requiring prolonged inpatient--based care. While many patients endure the acute complications of the procedure, it is common for BMT patients and their caregivers to experience increased risk of financial and emotional burden, hospital readmission, and health service utilization. This highlights the importance of active involvement of BMT patients in their own health care (self--efficacy).
Given the intense nature of BMT, however, caregivers also play a critical role in the process and are a necessary component of proceeding with transplant. As such, caregiver activation on behalf of the patient plays a critical role in effective patient--caregiver-provider partnerships, which is increasingly recognized as the optimal model for health care delivery, particularly for those facing life--altering medical treatments. It is essential to develop effective strategies to enhance this partnership. Health information technology (IT)-mediated tools offer the potential to overcome constraints in health care delivery limited by provider time, complicated health information, and financial pressures. Significant gaps in knowledge exist on the use of health IT tools using low- cost and well- accepted delivery platforms in routine inpatient care, especially for high- risk or critically ill populations. We hypothesize that a tablet--based tool displaying personal health information could provide a platform to promote caregiver activation and enhance health communication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The BMT Roadmap information system will be tested in 20 caregivers of patients undergoing autologous or allogeneic BMT and 20 patients undergoing autologous or allogeneic BMT.
| Arm | Type | Receives |
|---|---|---|
| BMT Roadmap | Experimental | Other: BMT RoadmapThe BMT Roadmap information system will be tested in 20 caregivers of patients undergoing autologous or allogeneic BMT and in 20 patients undergoing autologous or allogeneic BMT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants will be recruited by BMT RN Coordinators and physicians prior to patient admission to the BMT Unit. Caregiver (age 18 years or older) of any patient eligible to undergo autologous or allogeneic BMT and any patient (age 18 years or older) eligible to undergo autologous or allogeneic BMT will be recruited during the "Pre-Transplant Work-up" stage in the outpatient setting.
- CAREGIVER PARTICIPANTS: Caregiver (age 18 years or older) of a patient who will be hospitalized to undergo first-time autologous (self) or allogeneic (alternative donor) BMT in the University of Michigan Mott Children's Hospital BMT Unit
- PATIENT PARTICIPANTS: Patients (age 18 years or older) who will be hospitalized to undergo first-time autologous or allogeneic BMT will be given the opportunity to assent/consent and participate in the study. With his/her permission, the patient will also be provided with their own iPad® BMT Roadmap information system to use. Qualitative interviews will be conducted in patients with their assent/consent.
- Ability to speak and read proficiently in English (the study's instruments have not been translated and validated in languages other than English)
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Not willing and able to provide informed consent
- Not willing to comply with study procedures and reporting requirements
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 |
|---|---|---|
| BMT RoadmapThe BMT Roadmap is a health IT System that has been developed for use on the Apple iPad® to give the patient and caregivers easy access to test results, current treatment and contact information to hopefully increase active participation and engagement in transplant care. | Other | BMT Roadmap |
Primary outcome
Percentage of Caregivers Accrued
Time frame: 5 months
Feasibility of the study will be determined by demonstrating that accruing at least 20% of caregivers from the BMT patient population is possible.
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 2 Dec 2017.
- Derived from this study: PubMed 30232587Fauer AJ, Hoodin F, Lalonde L, Errickson J, Runaas L, Churay T, Seyedsalehi S, Warfield C, Chappell G, Brookshire K, Chaar D, Shin JY, Byrd M, Magenau J, Hanauer DA, Choi SW. Impact of a health information technology tool addressing information needs of caregivers of adult and pediatric hematopoietic stem cell transplantation patients. Support Care Cancer. 2019 Jun;27(6):2103-2112. doi: 10.1007/s00520-018-4450-4. Epub 2018 Sep 20.
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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.
Sung Choi, M.D., M.S. principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMT Roadmap in people with Patients Undergoing Bone Marrow Transplant (BMT), run by University of Michigan Rogel Cancer Center 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 6 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 2 Dec 2017. 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?
Percentage of Caregivers Accrued (time frame: 5 months). 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 NCT03161665, 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 2 Dec 2017.