Mobile Application to Assist Adherence to Oral Anticancer Agents and Symptom Management

Baskent University

Status: Completed

Conditions: Adherence to Medication Regime; Symptom Management; Cancer

Treatments: Other: Mobile Application Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04626830

Project No: 2018.1.18.

Details and patient eligibility

About

The use of oral anticancer agents (OAAs) in cancer treatment has increased especially in the last two decades. The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.The aim of this study is to explore how a Smartphone mobile application can help improve the cancer treatment process in people who are used oral anticancer agents. This study will be done a randomized-controlled trial to test the intervention.

Full description

Background: The use of mobile health technologies in the management of OAA can be beneficial in terms of treatment adherence and symptom management.

Objective/Hipothesis: The purpose of this study is to explore the effectiveness of a mobile application on treatment adherence and symptom management in patients using OAA. The following hypotheses (H) will teste in this study:

H0a: A mobile application developed for patients using OAA has not increased treatment adherence.

H1a: A mobile application developed for patients using OAA has increased treatment adherence.

H0b: A mobile application developed for patients using OAA has not decreased the frequency and severity of symptoms.

H1b: A mobile application developed for patients using OAA has decreased the frequency and severity of symptoms.

Study Design: The investigators will recruit and randomly assign 100 patients from the two cancer care sites who have recently been prescribed oral anticancer agents to receive either the mobile app intervention or standard care. Participants will be stratified by age and anticancer treatment ( i.e. simple and complex) regimen. Patients will be follow 6 months. Medication adherence, symptom severity will serve as primary outcomes.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Using OAAs for cancer treatment and taking at least one cure
• Taking OAAs for at least six months
• Knowing the diagnosis
• Communicating verbally
• Scoring less than three on the Eastern Cooperative Oncology Group (ECOG) scale
• Having a smartphone with IOS or Android software
• Actively using the smartphone
• Consenting to download the mobile application on one's mobile phone
• Volunteering to participate in the research.

Exclusion criteria

• Participation in a similar study aimed at increasing treatment adherence
• Having physical, cognitive, or memory-related problems that significantly impair one's daily activities
• Having a smartphone with Windows or Blackberry software.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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77 participants in 2 patient groups

Mobile Application Intervention

Experimental group

Description:

Participants in the intervention group will receive 6 months the mobile application (OKTED) for improving symptoms and adherence to oral anticancer agents. The mobile application will consist of three modules. The first module will include OAA-specific information, a calendar in which start/end dates can be record, and a medication reminder. The second module will include information about common and urgent symptoms and recommendations for the management of these symptoms. The last module will comprise a question and answer section.

Treatment:

Other: Mobile Application Intervention

Standard Care

No Intervention group

Description:

Participants in the control group will receive standard oncology care only.