Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Study

Not Applicable

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT06952790
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Study Start: 2025-08-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of patient satisfaction measured by SUS	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States