Randomized Phase II Study to Evaluate Efficacy of Web-based Patient-reported Outcome (PRO) Application in Solid Cancer Patients (Mobile PRO)

This is a single-center, open-label, Phase 2 study to evaluate the feasibility of a mobile PRO and its efficacy in reducing unplanned healthcare utilization (unplanned outpatient visits, emergency department visits, and hospitalizations).

Study Overview

• Status: Completed
• Conditions: Solid Cancer
• Intervention / Treatment: Device: Mobile PRO; Other: usual care

Detailed Description

The intervention lasted 12 weeks. Patients in the Mobile PRO group received instruction on symptom reporting and were asked to submit reports at baseline and at least once before each outpatient visit. Treating oncologist reviewed Mobile PRO entries during clinic visits and used the information in clinical decision-making; no automated alerts or additional staff-based interventions were implemented.

Usual-care patients did not use Mobile PRO; symptoms were assessed verbally during routine outpatient visits. AEs in both groups were graded using NCI-CTCAE version 5.0. All patients received chemotherapy according to institutional practice, including guideline-based antiemetic prophylaxis. Survival follow-up was conducted every 3 months after the 12-week intervention.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥19 years old
• Histologically or cytologically confirmed solid cancer (clinical diagnosis accepted for hepatocellular carcinoma per the American Association for the Study of Liver Disease guidelines)
• Receiving systemic therapy (cytotoxic, immunotherapy, targeted therapy, or combinations) as monotherapy or concurrent chemoradiotherapy
• Able to use a smartphone or tablet independently or with caregiver assistance.

Exclusion Criteria:

• Receiving third-line or later palliative systemic therapy
• Inability to understand PROM content.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile PRO; Mobile PRO group. Patients in the Mobile PRO group received instruction on symptom reporting and were asked to submit reports at baseline and at least once before each outpatient visit. Treating oncologist reviewed Mobile PRO entries during clinic visits and used the information in clinical decision-making; no automated alerts or additional staff-based interventions were implemented.	Device: Mobile PRO; Patients in the Mobile PRO group received instruction on symptom reporting and were asked to submit reports at baseline and at least once before each outpatient visit. Treating oncologist reviewed Mobile PRO entries during clinic visits and used the information in clinical decision-making; no automated alerts or additional staff-based interventions were implemented.
Sham Comparator: Control; Usual group Usual-care patients did not use Mobile PRO; symptoms were assessed verbally during routine outpatient visits. AEs in both groups were graded using NCI-CTCAE version 5.0. All patients received chemotherapy according to institutional practice, including guideline-based antiemetic prophylaxis.	Other: usual care; Usual-care patients did not use Mobile PRO; symptoms were assessed verbally during routine outpatient visits. AEs in both groups were graded using NCI-CTCAE version 5.0. All patients received chemotherapy according to institutional practice, including guideline-based antiemetic prophylaxis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of unplanned healthcare utilization per patient	the composite of unplanned outpatient visits, emergency departments, visits, or hospitalizations.	12-week intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on health-related QoL (HRQoL)	HRQoL was measured using the Korean version of EQ-5D-5L at baseline and 12 weeks, with index values derived from the Korean valuation set. For secondary analyses, EQ-5D-5L dimensions were dichotomized as "no problems" (Level 1) versus "any problems" (Levels 2-5).	12-week intervention period
Progression-free survival	The time from the date of starting chemotherapy to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.	From the date of starting chemotherapy to the date of first documentation of progression or death (up to approximately 1 years)
Overall survival	The time from the date of starting chemotherapy to the date of death from any cause, whichever occurs first.	From the date of starting chemotherapy to the date of death (up to approximately 1 years)
The proportions of individual components of unplanned healthcare use	Unplanned healthcare use was defined by its components: outpatient visits, emergency department visits, and hospital admissions. This outcome specifically measured the proportions of these three components.	12-week intervention period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of supportive medication prescriptions	The rate of supportive medication prescriptions, including anti-emetics, anti-diarrheal agents, digestives, analgesics, pegylated G-CSF, anti-histamine, corticosteroids, constipation medications, and other medication.	12-week intervention period

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): July 21, 2021

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Patient reported outcome
• Other Study ID Numbers: 2020-0716; CB-2017-B-2 (Other Grant/Funding Number: 2017 Cancer Research Support Project of the Korea Foundation for Cancer Research)

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