Smartphone App for Cancer Medication Adherence

NCT ID: NCT05225090

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2024-05-31

Brief Summary

For this current proposal, the investigator will conduct a single-center prospective non-randomized pilot interventional study in patients with any stage and type of cancer who are either taking at least one OACD or are taking at least one oral medication for chronic condition management in conjunction with any cancer treatment.

Primary Objective: To determine the feasibility of using a medication reminder application (Medisafe App) to improve medication adherence in cancer patients either receiving oral anticancer agents (OACDs) or receiving oral medications for chronic disease management (non-OACDs) in conjunction with non-oral cancer treatment.

Secondary Objectives: To compare and characterize medication adherence before and after the 12-week intervention using the Voils Extent of Adherence Scale and the Medisafe App. Also to determine the acceptability, utility and patient engagement with the App, to evaluate changes in healthcare related quality of life before and after the intervention, and to explore behaviors, knowledge, attitudes and beliefs related to medication adherence using a semi-structured interview delivered over the telephone.

Detailed Description

Many patients with cancer experience frustration with the large number and complex scheduling of their medications. This study will help find out how much "pill burden" exists in patients with cancer, and how a smartphone app can help patients take medications as providers prescribe. Results of this study may help figure out the best way to help patients manage medications in the future.

Conditions

Carcinoma; Cancer

Study Design

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

Study Groups

Smartphone App Intervention

Cancer patients taking at least one oral anti-cancer drug or oral medication to manage a chronic condition in conjunction with any cancer treatment will receive messages through the Medisafe App.

Group Type: OTHER

Smartphone App

Intervention Type: OTHER

Medisafe is a Med\_App that is free and has been used in several studies evaluating medication adherence. Patients will receive individualized instruction and be followed for 12 weeks. The researcher will show the patients how to input current medication list, set up medication reminders and track if daily doses have been taken using the App (20 minute training session). After the participant has input their medication information into the app, the researcher will assist the participant in adding an optional "Medifriend" who will be alerted if the participant misses a dose as an option. The participant will also be provided with written instructions about the Medisafe app to take home for reference. At each office visit (4, 8, and 12 weeks) participants will complete a medication checklist and reconciliation form with the research staff. Participants will also be asked to send a medication status report through the Medisafe app.

Interventions

Smartphone App

Medisafe is a Med\_App that is free and has been used in several studies evaluating medication adherence. Patients will receive individualized instruction and be followed for 12 weeks. The researcher will show the patients how to input current medication list, set up medication reminders and track if daily doses have been taken using the App (20 minute training session). After the participant has input their medication information into the app, the researcher will assist the participant in adding an optional "Medifriend" who will be alerted if the participant misses a dose as an option. The participant will also be provided with written instructions about the Medisafe app to take home for reference. At each office visit (4, 8, and 12 weeks) participants will complete a medication checklist and reconciliation form with the research staff. Participants will also be asked to send a medication status report through the Medisafe app.

Intervention Type: OTHER

Other Intervention Names

Medisafe App

Eligibility Criteria

Inclusion Criteria

• Any type/stage cancer
• Patients must be taking either:

• at least one oral anti-cancer drug (OACD) or
• at least one oral medication (non-OACD) for management of a chronic condition in addition to receiving non-oral cancer treatment
• Patients must have access to a mobile phone or tablet that can download the Medisafe App. (ie apple/android)
• Subjects must be able to complete self-administered questionnaires in English or Spanish.
• Co-enrollment in trials involving pharmacologic therapy is allowed.

Exclusion Criteria

• Inability to provide informed consent

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

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Melissa K Accordino

Assistant Professor of Medicine, Division of Hematology/Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Accordino, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAS5950

Identifier Type: -

Identifier Source: org_study_id