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

NCT07301996 | Completed

• 2 other identifiers: 2020-0716CB-2017-B-2
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Solid Cancer

Keywords

Patient reported outcome

Outcome Measures

Primary Outcomes (1)

• Rate of unplanned healthcare utilization per patient

  the composite of unplanned outpatient visits, emergency departments, visits, or hospitalizations.

  12-week intervention period

Secondary Outcomes (4)

• Impact on health-related QoL (HRQoL)

  12-week intervention period

• Progression-free survival

  From the date of starting chemotherapy to the date of first documentation of progression or death (up to approximately 1 years)

• Overall survival

  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

  12-week intervention period

Other Outcomes (1)

• The rate of supportive medication prescriptions

  12-week intervention period

Study Arms (2)

Mobile PRO

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Mobile PRO DEVICE

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.

Mobile PRO

usual care OTHER

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.

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: 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 Record Dates

• First Submitted: November 30, 2025
• First Posted: December 24, 2025
• Study Start: February 4, 2021
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)