Blood CancerNCT06645132
Understanding the Implementation of Cued Exercise Using Wearable Devices and a Custom Smartphone Application Following Bone Marrow Transplant.
A study testing exercise intervention in people with Blood Cancer and Bone Marrow Transplant (BMT), run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to pilot test the feasibility of providing patients diagnosed with a hematologic malignancy, undergoing an allogeneic bone marrow transplant, a wearable device and smartphone app (similar to a Fitbit), that would send personalized reminders to move during their post-transplant inpatient… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Cancer, Bone Marrow Transplant (BMT)
- What is being tested?
- exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least 18 years of age
- Diagnosed with hematologic malignancy
- Scheduled to receive an alloBMT
- Physician consent to participate in the study
Who cannot join
- Inability to complete 15 minutes walking unassisted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Understand the Feasibility of Implementing a Wearable Device Cueing System Following Bone Marrow Transplant
The purpose of this study is to pilot test the feasibility of providing patients diagnosed with a hematologic malignancy, undergoing an allogeneic bone marrow transplant, a wearable device and smartphone app (similar to a Fitbit), that would send personalized reminders to move during their post-transplant inpatient hospital stay to promote physical recovery and well-being.
Read the detailed description
Enrolled patients who have been diagnosed with a hematologic malignancy and are scheduled to undergo an allogeneic bone marrow transplant will use a custom-designed wearable device and smartphone application as a behavioral intervention to cue exercise. Participants will be asked to wear the wearable device for the duration of their post-transplant inpatient hospital stay.
Aim 1. To examine the potential efficacy of the wearable device + smartphone application to prompt alloBMT patients to move.
Aim 2. To receive participant feedback on their experience participating in the study.
- Conditions
- Blood Cancer, Bone Marrow Transplant (BMT)
- Being tested
- exercise intervention
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
Exercise intervention leveraging wearable devices and a custom smartphone application to cue exercise as a reminder during idle time during an inpatient hospital stay, post allogenic bone marrow transplant.
| Study group | Role | What they receive |
|---|---|---|
| Reminders to exercise through cues provided by wearable device + custom smartphone application | Experimental | Each participant receives 2 wearable devices and custom smartphone application. Participants will wear an activity monitor on their non-dominant wrist and contralateral ankle. Post-transplant inpatient days ~3-10, participants will schedule three cued exercise sessions each day using the smartphone application. At the scheduled time, the wearable devices will vibrate to indicate "time to exercise" and participants are encouraged to complete an exercise task for 15 minutes. Post-transplant inpatient hospital days ~1-2 and post-transplant inpatient hospital days ~11 until discharge patients will wear the devices but will not receive any cues. During these days, the monitors will only be measuring their movement without any intervention. Receives: Behavioral: exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot evaluation of intervention efficacy
Efficacy will be evaluated by examining the percentage of time participants responded to the cued exercise prompts.
Measured: cumulative percent from day 1 through discharge from hospital, on average day 30
Patient feedback from participation in the study
Patient experience will be evaluated by looking at the central tendencies of the ratings from the post-participation evaluation survey.
Measured: day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start28 Oct 2024
- Primary completion21 Jan 2025
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Whitney Morelli, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645132
- Sponsor's protocol ID
- PRO00051086
- Status last verified
- Nov 2024
- First submitted
- 14 Oct 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Understand the Feasibility of Implementing a Wearable Device Cueing System Following Bone Marrow Transplant
- ClinicalTrials.gov ID
- NCT06645132
- Acronym / sponsor ID
- PRO00051086
- Conditions
- Blood Cancer, Bone Marrow Transplant (BMT)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 16 Oct 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 purpose of this study is to pilot test the feasibility of providing patients diagnosed with a hematologic malignancy, undergoing an allogeneic bone marrow transplant, a wearable device and smartphone app (similar to a Fitbit), that would send personalized reminders to move during their post-transplant inpatient hospital stay to promote physical recovery and well-being.
Detailed description
Enrolled patients who have been diagnosed with a hematologic malignancy and are scheduled to undergo an allogeneic bone marrow transplant will use a custom-designed wearable device and smartphone application as a behavioral intervention to cue exercise. Participants will be asked to wear the wearable device for the duration of their post-transplant inpatient hospital stay.
Aim 1. To examine the potential efficacy of the wearable device + smartphone application to prompt alloBMT patients to move.
Aim 2. To receive participant feedback on their experience participating in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reminders to exercise through cues provided by wearable device + custom smartphone application | Experimental | Behavioral: exercise interventionEach participant receives 2 wearable devices and custom smartphone application. Participants will wear an activity monitor on their non-dominant wrist and contralateral ankle. Post-transplant inpatient days ~3-10, participants will schedule three cued exercise sessions each day using the smartphone application. At the scheduled time, the wearable devices will vibrate to indicate "time to exercise" and participants are encouraged to complete an exercise task for 15 minutes. Post-transplant inpatient hospital days ~1-2 and post-transplant inpatient hospital days ~11 until discharge patients will wear the devices but will not receive any cues. During these days, the monitors will only be measuring their movement without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Diagnosed with hematologic malignancy
- Scheduled to receive an alloBMT
- Physician consent to participate in the study
Key exclusion criteria (1 listed)
- Inability to complete 15 minutes walking unassisted
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 |
|---|---|---|
| exercise interventionExercise intervention leveraging wearable devices and a custom smartphone application to cue exercise as a reminder during idle time during an inpatient hospital stay, post allogenic bone marrow transplant. | Behavioural | Reminders to exercise through cues provided by wearable device + custom smartphone application |
Primary outcome
Pilot evaluation of intervention efficacy
Time frame: cumulative percent from day 1 through discharge from hospital, on average day 30
Efficacy will be evaluated by examining the percentage of time participants responded to the cued exercise prompts.
Patient feedback from participation in the study
Time frame: day 10
Patient experience will be evaluated by looking at the central tendencies of the ratings from the post-participation evaluation survey.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention in people with Blood Cancer and Bone Marrow Transplant (BMT), run by Medical College of Wisconsin 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 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pilot evaluation of intervention efficacy (time frame: cumulative percent from day 1 through discharge from hospital, on average day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2025.