Caregivers of Hematopoietic Stem Cell Transplant (HCT) PatientsNCT07352943
Development of a Mindfulness-Based Smartphone Application for BMT Caregivers
A study testing App in people with Caregivers of Hematopoietic Stem Cell Transplant (HCT) Patients, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This pilot study evaluates the feasibility, acceptability, usability, and engagement of a smartphone-delivered mindfulness intervention for caregivers of hematopoietic stem cell transplant (HCT) patients. Thirty caregivers will use the app for six weeks beginning the week prior to the patient's transplant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers of Hematopoietic Stem Cell Transplant (HCT) Patients
- What is being tested?
- App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18
- Identified caregiver of a patient scheduled for HCT at Moffitt Cancer Center
- Able to provide informed consent
- Able to read and write in English
- Owns a smartphone and willing to download the study app
Who cannot join
- None beyond failure to meet inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Moffitt Cancer Center
Tampa, Florida, 33612
Christine Vinci, PhD
Joseph Pidala, MD, PhD
About this study
This pilot study evaluates the feasibility, acceptability, usability, and engagement of a smartphone-delivered mindfulness intervention for caregivers of hematopoietic stem cell transplant (HCT) patients. Thirty caregivers will use the app for six weeks beginning the week prior to the patient's transplant. Participants will complete baseline and end-of-treatment surveys and a brief qualitative interview.
- Being tested
- App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppBehavioural
A smartphone-delivered mindfulness program providing daily modules, guided meditations, brief strategies, and reflection prompts designed to reduce caregiver burden and distress.
| Study group | Role | What they receive |
|---|---|---|
| App | Experimental | Participants receive access to the smartphone application, a 6-week mindfulness-based behavioral intervention adapted from the FOCUS program. Caregivers begin using the app the week prior to the patient's hematopoietic stem cell transplant and continue through six weeks of daily modules that include audio meditations, videos, text-based content, and reflection exercises. Receives: Behavioral: App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment Rate
Recruitment will be assessed by the ability to recruit approximately 4 caregivers per month until the target sample of 30 is reached.
Measured: During the enrollment period (anticipated 6-8 months)
Feasibility: Retention Rate
Percentage of enrolled participants who complete the study through the end-of-treatment.
Measured: Baseline to 6 weeks
Feasibility: Survey Completion
Percentage of participants who complete the baseline REDCap survey and the end-of-treatment survey.
Measured: Baseline and 6 weeks
Acceptability: System Usability Scale (SUS)
Usability of the app measured using the System Usability Scale.
Measured: 6 weeks
Engagement: Module Completion Rate
Number of modules completed per week.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregivers of Hematopoietic Stem Cell Transplant (HCT) PatientsStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Christine Vinci, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352943
- Sponsor's protocol ID
- MCC-23529
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mindfulness-Based Smartphone Application for BMT Caregivers
- ClinicalTrials.gov ID
- NCT07352943
- Acronym / sponsor ID
- MCC-23529
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
This pilot study evaluates the feasibility, acceptability, usability, and engagement of a smartphone-delivered mindfulness intervention for caregivers of hematopoietic stem cell transplant (HCT) patients. Thirty caregivers will use the app for six weeks beginning the week prior to the patient's transplant. Participants will complete baseline and end-of-treatment surveys and a brief qualitative interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| App | Experimental | Behavioral: AppParticipants receive access to the smartphone application, a 6-week mindfulness-based behavioral intervention adapted from the FOCUS program. Caregivers begin using the app the week prior to the patient's hematopoietic stem cell transplant and continue through six weeks of daily modules that include audio meditations, videos, text-based content, and reflection exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18
- Identified caregiver of a patient scheduled for HCT at Moffitt Cancer Center
- Able to provide informed consent
- Able to read and write in English
- Owns a smartphone and willing to download the study app
Key exclusion criteria (1 listed)
- None beyond failure to meet inclusion criteria
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 |
|---|---|---|
| AppA smartphone-delivered mindfulness program providing daily modules, guided meditations, brief strategies, and reflection prompts designed to reduce caregiver burden and distress. | Behavioural | App |
Primary outcome
Feasibility: Recruitment Rate
Time frame: During the enrollment period (anticipated 6-8 months)
Recruitment will be assessed by the ability to recruit approximately 4 caregivers per month until the target sample of 30 is reached.
Feasibility: Retention Rate
Time frame: Baseline to 6 weeks
Percentage of enrolled participants who complete the study through the end-of-treatment.
Feasibility: Survey Completion
Time frame: Baseline and 6 weeks
Percentage of participants who complete the baseline REDCap survey and the end-of-treatment survey.
Acceptability: System Usability Scale (SUS)
Time frame: 6 weeks
Usability of the app measured using the System Usability Scale.
Engagement: Module Completion Rate
Time frame: 6 weeks
Number of modules completed per week.
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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Caregivers of Hematopoietic Stem Cell Transplant (HCT) Patients
Active, not recruiting
Mobile CARE-App to Promote Coping for Caregivers of Patients Receiving Stem Cell Transplant
Bone Marrow Transplant Complications, Hematologic Malignancy
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.
Christine Vinci, PhD principal investigator
Moffitt 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 App in people with Caregivers of Hematopoietic Stem Cell Transplant (HCT) Patients, run by H. Lee Moffitt Cancer Center and Research Institute 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 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: opening soon, as of the sponsor's last update on 20 Jan 2026. 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?
Contact Helen Yates (813-745-5008, Helen.Yates@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment Rate (time frame: During the enrollment period (anticipated 6-8 months)). The study lists 5 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 20 Jan 2026.