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

Sponsor

Baskent University (Other)

Overall Status

Completed

CT.gov ID

NCT04626830

Collaborator

Koç University (Other), Gazi University (Other)

Enrollment

Location

Arms

17.2

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Adherence to Medication Regime Symptom Management	Other: Mobile Application Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 25, 2018

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Adherence to Oral Anticancer Agents [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".
Change in Symptoms and Side Effects [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.