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NCT Number: NCT07352943

Development of a Mindfulness-Based Smartphone Application for BMT Caregivers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location contact

Christine Vinci, PhD

PRINCIPAL_INVESTIGATOR

Joseph Pidala, MD, PhD

SUB_INVESTIGATOR

Steve Sutton, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App

Behavioral

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

Primary outcomes

  1. 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.

  2. Feasibility: Retention Rate

    Time frame: Baseline to 6 weeks

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

  3. Feasibility: Survey Completion

    Time frame: Baseline and 6 weeks

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

  4. Acceptability: System Usability Scale (SUS)

    Time frame: 6 weeks

    Usability of the app measured using the System Usability Scale.

  5. Engagement: Module Completion Rate

    Time frame: 6 weeks

    Number of modules completed per week.

Study contacts

Contact information is provided by the study sponsor or research team.

Helen Yates

CONTACT

[email protected]

813-745-5008

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.