CancerNCT06952790
Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Study
A study testing EveryDose Mobile Application in people with Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- EveryDose Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Aaron Riffa, BSN, 305-243-5716, aaronriffa@med.miami.edu
Frank Penedo, PhD
About this study
Official title: 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).
- Conditions
- Cancer
- Being tested
- EveryDose Mobile Application
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EveryDose Mobile ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EveryDose Mobile Application Group | Experimental | Participants in this group will use the EveryDose mobile application for up to 12 weeks. Receives: Behavioral: EveryDose Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who agree to use the EveryDose application
Percentage of patients who agree to use the EveryDose application
Measured: 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%)
Measured: 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.
Measured: up to 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start2 Oct 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Penedo, University of Miami
- Investigators
- Frank Penedo, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952790
- Sponsor's protocol ID
- 20240618
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Qualitative Study: Utilization of an Adherence Application
- ClinicalTrials.gov ID
- NCT06952790
- Acronym / sponsor ID
- 20240618
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EveryDose Mobile Application Group | Experimental | Behavioral: EveryDose Mobile ApplicationParticipants in this group will use the EveryDose mobile application for up to 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EveryDose Mobile ApplicationParticipants 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. | Behavioural | EveryDose Mobile Application Group |
Primary outcome
Percentage of patients who agree to use the EveryDose application
Time frame: up to 12 weeks
Percentage of patients who agree to use the EveryDose application
EveryDose application adherence measured by percentage
Time frame: 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
Time frame: up to 12 weeks
Will be measured by the ratio of doses taken to the doses prescribed over a given time period.
1 secondary outcome
Percentage of patient satisfaction measured by SUS
Time frame: 12 weeks (post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Penedo, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EveryDose Mobile Application in people with Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica MacIntyre, DNP (305-243-4570, jmacintyre@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who agree to use the EveryDose application (time frame: up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.