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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626830
• Other study ID #: Project No: 2018.1.18.
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: November 2020
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 1, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adherence to Medication Regime
• Cancer
• Symptom Management

Intervention

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.

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara

Sponsors (3)

Lead Sponsor	Collaborator
Baskent University	Gazi University, Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adherence to Oral Anticancer Agents	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 a 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
Primary	Change in Symptoms and Side Effects	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 a=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