Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Study

NCT06952790 | Recruiting

• 1 other identifier: 20240618
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Percentage of patient satisfaction measured by SUS

  12 weeks (post intervention)

Study Arms (1)

EveryDose Mobile Application Group

EXPERIMENTAL

Participants in this group will use the EveryDose mobile application for up to 12 weeks.

Behavioral: EveryDose Mobile Application

Interventions

EveryDose Mobile Application BEHAVIORAL

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.

EveryDose Mobile Application Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Frank Penedo, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica MacIntyre, DNP

CONTACT

305-243-4570; jmacintyre@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 1, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)