Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Study

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: Cancer
• Intervention / Treatment: Behavioral: EveryDose Mobile Application

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica MacIntyre, DNP; Phone Number: 305-243-4570; Email: jmacintyre@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Frank Penedo, PhD
      • Contact: Aaron Riffa, BSN; Phone Number: 305-243-5716; Email: aaronriffa@med.miami.edu
      • Sub-Investigator: Jessica MacIntyre, DNP

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Percentage of patients who agree to use the EveryDose application	up to 12 weeks
EveryDose application adherence measured by percentage	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	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	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

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

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

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): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• 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