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

November 6, 2020 updated by: Akile Karaaslan Eşer, Baskent University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06790
        • Baskent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Standard Care
Participants in the control group will receive standard oncology care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Adherence to Oral Anticancer Agents
Time Frame: baseline, 1 month, 3 months, 6 months
The patients' adherence levels will be assess using the Oral Chemotherapy Adherence Scale (OCAS). The OCAS was developed by Bagcivan and Akbayrak (2015), and its Cronbach α coefficient was found to be 0.738. The scale (19 items, 5-point Likert-type) is a valid and reliable scale for adult patients who use OAAs. A total score of 84 and above is interpreted as "good adherence;" a total score of 83 and below is interpreted as "poor adherence".
baseline, 1 month, 3 months, 6 months
Change in Symptoms and Side Effects
Time Frame: baseline, 1 month, 3 months, 6 months
The Memorial Symptom Assessment Scale (MSAS) is a multidimensional tool developed to evaluate the prevalence, characteristics, and distress levels of common cancer-related symptoms over seven days (Cronbach α=0.84). The MSAS is a reliable and valid instrument in the Turkish population. The scale has 32 items and three sub-dimensions: The Global Distress Index, The Physical Symptom Distress Scores, and The Psychologic Symptom Distress Scores. The total MSAS score is the average of the symptom scores of all 32 items. Twenty-four symptoms are evaluated in terms of severity, frequency and distress, and eight symptoms are evaluated in terms of severity and distress. If a symptom was experienced, the patient describes its severity on a 4-point categorical scale; its frequency, if appropriate, on a 4-point categorical scale; and its associated distress on a 5-point categorical scale. Each symptom score is the average of the dimensions (frequency, severity, distress dimensions).
baseline, 1 month, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Collaborators

Gazi University
Koç University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2018

Primary Completion (Actual)

October 31, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Project No: 2018.1.18.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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