Development of a Mindfulness-Based Smartphone Application for BMT Caregivers

January 13, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Joseph Pidala, MD, PhD
        • Sub-Investigator:
          • Steve Sutton, PhD
        • Principal Investigator:
          • Christine Vinci, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App
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.
Behavioral: App
A smartphone-delivered mindfulness program providing daily modules, guided meditations, brief strategies, and reflection prompts designed to reduce caregiver burden and distress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the enrollment period (anticipated 6-8 months)
Feasibility: Retention Rate
Time Frame: Baseline to 6 weeks
Percentage of enrolled participants who complete the study through the end-of-treatment.
Baseline to 6 weeks
Feasibility: Survey Completion
Time Frame: Baseline and 6 weeks
Percentage of participants who complete the baseline REDCap survey and the end-of-treatment survey.
Baseline and 6 weeks
Acceptability: System Usability Scale (SUS)
Time Frame: 6 weeks
Usability of the app measured using the System Usability Scale.
6 weeks
Engagement: Module Completion Rate
Time Frame: 6 weeks
Number of modules completed per week.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Christine Vinci, PhD, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23529

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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