NCT04626830

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

The Effect of a Mobile Application on Treatment Adherence and Symptom Management in Patients Using Oral Anticancer Agents: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Baskent University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Cancer
• Adherence to Medication Regime
• Symptom Management

Interventions

Type	Name	Description
OTHER	Mobile Application Intervention	Participants appointed to the intervention group will receive the mobile application intervention for six months after enrollment. The mobile app (OKTED) intervention will consist of completing responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses.

Timeline

• Start date: 2018-06-25
• Primary completion: 2019-10-31
• Completion: 2019-12-01
• First posted: 2020-11-13
• Last updated: 2020-11-13

Locations

1 site across 1 country: Turkey (Türkiye)