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Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Study

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06952790
Enrollment
25
Registered
2025-05-01
Start date
2025-10-02
Completion date
2027-01-01
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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).

Interventions

BEHAVIORALEveryDose 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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients who agree to use the EveryDose applicationup to 12 weeksPercentage of patients who agree to use the EveryDose application
EveryDose application adherence measured by percentageup to 12 weeksThe percentage of weeks out of 12 week-period that the patient used the App (\> 50%)
Medication Adherence measured by dose ratioup to 12 weeksWill be measured by the ratio of doses taken to the doses prescribed over a given time period.

Secondary

MeasureTime frameDescription
Percentage of patient satisfaction measured by SUS12 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.

Countries

United States

Contacts

CONTACTJessica MacIntyre, DNP
jmacintyre@med.miami.edu305-243-4570
PRINCIPAL_INVESTIGATORFrank Penedo, PhD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026