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Not yet recruiting NCT07352943

Development of a Mindfulness-Based Smartphone Application for BMT Caregivers

No phase Interventional Caregivers of Hematopoietic Stem Cell Transplant (HCT) Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: App.
Who it may be relevant to
Registry conditions: Caregivers of Hematopoietic Stem Cell Transplant (HCT) Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • Feasibility: Recruitment Rate [Time frame: During the enrollment period (anticipated 6-8 months)]
  • Feasibility: Retention Rate [Time frame: Baseline to 6 weeks]
  • Feasibility: Survey Completion [Time frame: Baseline and 6 weeks]
  • Acceptability: System Usability Scale (SUS) [Time frame: 6 weeks]
  • Engagement: Module Completion Rate [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Moffitt Cancer Center — Tampa

Identifiers

NCT: NCT07352943 · MCC-23529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗