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Completed

NCT Number: NCT04568278

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

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Key information

Conditions

Neoplasms Behavior Health Behavior Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danbee Kang, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ePRO-CTCAE application

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 29, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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