Development of a Mindfulness-Based Smartphone Application for BMT Caregivers

NCT07352943 | Not Yet Recruiting

• 1 other identifier: MCC-23529
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregivers of Hematopoietic Stem Cell Transplant (HCT) Patients

Outcome Measures

Primary Outcomes (5)

• 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.

  During the enrollment period (anticipated 6-8 months)

• Feasibility: Retention Rate

  Percentage of enrolled participants who complete the study through the end-of-treatment.

  Baseline to 6 weeks

• Feasibility: Survey Completion

  Percentage of participants who complete the baseline REDCap survey and the end-of-treatment survey.

  Baseline and 6 weeks

• Acceptability: System Usability Scale (SUS)

  Usability of the app measured using the System Usability Scale.

  6 weeks

• Engagement: Module Completion Rate

  Number of modules completed per week.

  6 weeks

Study Arms (1)

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.

Behavioral: App

Interventions

App BEHAVIORAL

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

App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Interventions

Amyloid

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Christine Vinci, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Yates

CONTACT

813-745-5008; Helen.Yates@moffitt.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)