Smartphone App for Cancer Medication Adherence

NCT05225090 | Completed DMC

• 1 other identifier: AAAS5950
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma; Cancer

Keywords

any stage

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects enrolled that complete the 12-week intervention and assessments

  To determine the feasibility of using a medication reminder application (Medisafe App) to improve medication adherence in cancer patients. Feasibility defined as completing the 12-week intervention and the endpoint assessments. Patients will be tallied.

  12 weeks

Secondary Outcomes (6)

• Change in mean score on the Voils Extent of Adherence Scale for oral caner therapy use between baseline and 12 weeks

  Baseline and 12 weeks

• Change in mean score on the Voils Extent of Adherence Scale for global medication use between baseline and 12 weeks

  Baseline and 12 weeks

• Mean Score to Medication Self-Efficacy Scale (MASES) to assess a patient's confidence in their ability to take their medications in a variety of situations

  12 weeks

• Mean Score on the User Version of the Mobile Application Rating Scale

  12 weeks

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Score before and after the intervention

  Baseline and 12 weeks

Study Arms (1)

Smartphone App Intervention

OTHER

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.

Other: Smartphone App

Interventions

Smartphone App 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.

Also known as: Medisafe App

Smartphone App Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Melissa Accordino, MD

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Division of Hematology/Oncology

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: February 4, 2022
• Study Start: January 15, 2020
• Primary Completion: August 30, 2023
• Study Completion: May 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)