Clinical trial NCT04626830: Mobile Application to Assist Adherence to Oral Anticancer Agents and Symptom Management
Official title: The Effect of a Mobile Application on Treatment Adherence and Symptom Management in Patients Using Oral Anticancer Agents: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Adherence to Medication Regime
Symptom Management
Keywords: Cancer
Mobile applications
Oral anticancer agents
Oral Chemotherapy
Medication adherence
Nursing
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Koç University
name: Gazi University
First posted: 2020-11-13
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Adherence to Oral Anticancer Agents
timeFrame: baseline, 1 month, 3 months, 6 months
measure: Change in Symptoms and Side Effects
timeFrame: baseline, 1 month, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Başkent University
Study officials:
References:
citation: 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.