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Development of a Mindfulness-Based Smartphone Application for BMT Caregivers

Development of a Mindfulness-Based Smartphone Application for BMT Caregivers

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07352943
Enrollment
30
Registered
2026-01-20
Start date
2026-08-01
Completion date
2026-12-01
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers of Hematopoietic Stem Cell Transplant (HCT) Patients

Brief 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. Participants will complete baseline and end-of-treatment surveys and a brief qualitative interview.

Interventions

BEHAVIORALApp

A smartphone-delivered mindfulness program providing daily modules, guided meditations, brief strategies, and reflection prompts designed to reduce caregiver burden and distress.

Sponsors

H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER
American Cancer Society, Inc.
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* None beyond failure to meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Feasibility: Recruitment RateDuring 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 RateBaseline to 6 weeksPercentage of enrolled participants who complete the study through the end-of-treatment.
Feasibility: Survey CompletionBaseline and 6 weeksPercentage of participants who complete the baseline REDCap survey and the end-of-treatment survey.
Acceptability: System Usability Scale (SUS)6 weeksUsability of the app measured using the System Usability Scale.
Engagement: Module Completion Rate6 weeksNumber of modules completed per week.

Countries

United States

Contacts

CONTACTHelen Yates
Helen.Yates@moffitt.org813-745-5008
PRINCIPAL_INVESTIGATORChristine Vinci, PhD

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026