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NCT Number: NCT06952790

Fostering Oral Chemotherapy Understanding and Safety (FOCUS) Study

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).

Recruiting

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Aaron Riffa, BSN

CONTACT

[email protected]

305-243-5716

Frank Penedo, PhD

PRINCIPAL_INVESTIGATOR

Jessica MacIntyre, DNP

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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%)

  3. 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.

Secondary outcomes

  1. Percentage of patient satisfaction measured by SUS

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica MacIntyre, DNP

CONTACT

[email protected]

305-243-4570

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 1, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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