Mobile Application Using the PRO-CTCAE to Improve Patients' Participation in Symptom Management During Treatment.

February 24, 2026 updated by: Juhee Cho, Samsung Medical Center

Effect of a Mobile Application System Using the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to Improve Patients' Participation in Symptom Management During Cancer Treatment.

This study aims to evaluate the effect of a mobile application system using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to improve patients' participation in symptom management during cancer treatment. Our hypothesis is that patients who use a mobile application using the PRO-CTCAE will more likely to recognize symptoms due to cancer treatment and report them better to their clinicians than patients who do not use the mobile application.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial to evaluate the effect of a mobile application system using the Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to improve patients' participation in symptom management during cancer treatment. Breast, lung, head and neck, esophagus, and gynecologic cancer patients who will begin new lines of chemotherapy or radiation therapy will be randomly assigned into the intervention and control groups (2:1 ratio). The intervention group will have the mobile application installed on their smart phones which they could record symptoms and adverse events due to cancer treatments using the pre-specified PRO-CTCAE questions for different types of cancer. The control group will have usual care. Primary endpoint is patients' participation/engagement of reporting symptoms and it will be evaluated at 8 weeks after the intervention using a questionnaire developed by the research team. Secondary end points are unexpected hospital visits during treatment during 8 weeks after the beginning of the treatment and quality of life at 8 weeks after the intervention.

Study Type

Interventional

Enrollment (Actual)

222

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

  • South Korea
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea, 135-710
        • Danbee Kang

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are scheduled to have chemotherapy or radiation therapy.
  • Patients who own a smartphone (Android) and who can use mobile applications.
  • Patients who understand the purpose of this study and agree to participate in the study
  • Patients age over 18 years old (no age limit, but if necessary informed consent of the caregivers will be obtained for the patients whose age are over 70 years old)

Exclusion Criteria:

  • Patients whose life expectancy is less than 6 months (hospice)
  • Patients who would any physical or mental problems that would make them difficult to use the applications

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
a mobile application using the PRO-CTCAE along with usual care
Other: ePRO-CTCAE application
The intervention will be the use of a mobile application for recording symptoms during cancer treatments. Patients in the intervention group will have the mobile application (e-PRO) installed on their smart phones on the first day of cancer treatment (chemotherapy or radiation therapy) and patients will be asked to use the application for 8 weeks. Every week, the application will ask patients to report symptoms they experienced during past 7 days using the pre-specified PRO-CTCAE questions for different types of cancer. Patients also can memo and save photos related symptoms using the application and patients can monitor the progression of the symptoms over time.
No Intervention: Controlled Group
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' participation in symptom management
Time Frame: 8 weeks after the intervention
Patients' participation in reporting and managing symptoms due to cancer treatment will be measured using 10 questions developed by study team. The assessment is composed of 6 items on the importance of participation and 4 items on the barriers to participation in symptom management. The total scores had range from 0 to 10. Higher score means better outcome.
8 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30
Time Frame: 8 weeks after the intervention
State of well-being evaluated by an individual, including both physical, mental, social, and spiritual areas. This will be measured using relevant items of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Scores will be calculated by manual (0-100) and higher score means better quality of life.
8 weeks after the intervention
Unexpected visits
Time Frame: 8 weeks after the intervention
number of unexpected hospital visits (emergency room visits, unplanned outpatient visits, or unplanned hospitalization) due to symptoms or adverse events due to cancer treatment
8 weeks after the intervention

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

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)

October 5, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

September 20, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ePRO-CTCAE_2020

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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