Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Study

NCT ID: NCT06952790

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-02
• Study Completion Date: 2026-05-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

EveryDose Mobile Application Group

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

Group Type: EXPERIMENTAL

EveryDose Mobile Application

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Frank Penedo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Penedo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica MacIntyre, DNP

Role: CONTACT

jmacintyre@med.miami.edu

305-243-4570

Facility Contacts

Aaron Riffa, BSN

Role: primary

aaronriffa@med.miami.edu

305-243-5716

Other Identifiers

20240618

Identifier Type: -

Identifier Source: org_study_id