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

NCT04626830 | Completed

• 1 other identifier: Project No: 2018.1.18.
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Adherence to Medication Regime; Symptom Management

Keywords

Cancer; Mobile applications; Oral anticancer agents; Oral Chemotherapy; Medication adherence; Nursing

Outcome Measures

Primary Outcomes (2)

• 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 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

  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

Study Arms (2)

Mobile Application Intervention

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Participants in the control group will receive standard oncology care only.

Interventions

Mobile Application Intervention OTHER

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.

Mobile Application Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University: lead
• Koç University: collaborator
• Gazi University: collaborator

Study Sites (1)

Başkent University

Ankara, 06790, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33991868 DERIVED

MeSH Terms

Conditions

Neoplasms; Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 13, 2020
• Study Start: June 25, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 1, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)