Mobile Application to Assist Adherence to Oral Anticancer Agents and Symptom Management
NCT ID: NCT04626830
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
77 participants
INTERVENTIONAL
2018-06-25
2019-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mobile Application Intervention
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.
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.
Standard Care
Participants in the control group will receive standard oncology care only.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Having physical, cognitive, or memory-related problems that significantly impair one's daily activities
* Having a smartphone with Windows or Blackberry software.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Koç University
OTHER
Gazi University
OTHER
Baskent University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Akile Karaaslan Eşer
Assistant professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Başkent University
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Karaaslan-Eser A, Ayaz-Alkaya S. The effect of a mobile application on treatment adherence and symptom management in patients using oral anticancer agents: A randomized controlled trial. Eur J Oncol Nurs. 2021 Jun;52:101969. doi: 10.1016/j.ejon.2021.101969. Epub 2021 May 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Project No: 2018.1.18.
Identifier Type: -
Identifier Source: org_study_id