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

NCT04568278 | Completed DMC

• 1 other identifier: ePRO-CTCAE_2020
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Neoplasms

Keywords

patient-reported outcome; PRO-CTCAE; mobile application; patient engagement

Outcome Measures

Primary Outcomes (1)

• Patients' participation in symptom management

  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 Outcomes (2)

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30

  8 weeks after the intervention

• Unexpected visits

  8 weeks after the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

a mobile application using the PRO-CTCAE along with usual care

Other: ePRO-CTCAE application

Controlled Group

NO INTERVENTION

Usual care

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Danbee Kang

Seoul, 135-710, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Lee M, Kang D, Kang E, Kim S, Kim Y, Ahn JS, Park S, Lee YY, Oh D, Noh JM, Cho J. Efficacy of the PRO-CTCAE mobile application for improving patient participation in symptom management during cancer treatment: a randomized controlled trial. Support Care Cancer. 2023 May 6;31(6):321. doi: 10.1007/s00520-023-07779-3.

  PMID: 37148373 DERIVED

MeSH Terms

Conditions

Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistician who will analyze the results of the study will be blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cancer Education Center, Samsung Medical Center

Model Details: Randomized Controlled Trial, Single center, Open label

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 29, 2020
• Study Start: October 5, 2020
• Primary Completion: March 31, 2021
• Study Completion: December 30, 2022
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)