Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Study

August 27, 2026 updated by: Frank Penedo, University of Miami

Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Qualitative Study: Utilization of an Adherence Application

The purpose of this study is to learn about the experiences of cancer patients during treatment utilizing a mobile app called EveryDose© to track prescribed oral treatment for cancer. Based on these experiences, the study team will decide on expanding this pilot study to evaluate other methods that may prove to be beneficial in supporting cancer patient's ability to take cancer medications as prescribed (another common phrase used for this is adherence to treatment).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

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
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Frank Penedo, PhD
        • Contact:
        • Sub-Investigator:
          • Jessica MacIntyre, DNP

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

No

Description

Inclusion Criteria:

  • Any sex/gender Able to provide written informed consent
  • Able to read/understand English or Spanish
  • Diagnosis of hematologic or solid tumor cancer diagnosis
  • Prescribed an oral anti-cancer drug as monotherapy treatment for the first time by their treating oncologist.
  • Internet access on a smartphone, tablet, or computer

Exclusion Criteria:

  • Less than 18 years of age
  • Unable to provide written informed consent
  • Unable to read/understand English or Spanish
  • History of dementia or major psychiatric disease that would interfere with study participation
  • Prior treatment with an oral anti-cancer treatment
  • Participating in another clinical trial during the time of screening.

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: EveryDose Mobile Application Group
Participants in this group will use the EveryDose mobile application for up to 12 weeks.
Behavioral: EveryDose Mobile Application
Participants will use this application every day for up to 10 minutes, for up to 12 weeks. The purpose of the application is to improve medication adherence. Participants will receive an alert to the mobile device while at home to ensure medication was taken, and to serve as a medication log.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who agree to use the EveryDose application
Time Frame: up to 12 weeks
Percentage of patients who agree to use the EveryDose application
up to 12 weeks
EveryDose application adherence measured by percentage
Time Frame: up to 12 weeks
The percentage of weeks out of 12 week-period that the patient used the App (> 50%)
up to 12 weeks
Medication Adherence measured by dose ratio
Time Frame: up to 12 weeks
Will be measured by the ratio of doses taken to the doses prescribed over a given time period.
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patient satisfaction measured by SUS
Time Frame: 12 weeks (post intervention)
Percentage of patients who are satisfied with the EveryDose© mobile app (at least 80%) via the Systems Usability (SUS) survey by providers and patients. Survey asks patient about their satisfaction with the mobile application. Responses range from strongly disagree to strongly agree.
12 weeks (post intervention)

Collaborators and Investigators

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

Sponsor

University of Miami

Investigators

  • Principal Investigator: Frank Penedo, PhD, University of Miami

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 (Actual)

October 2, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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