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

NCT07301996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-12-24

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-04
Primary Completion
2021-07-21
Completion
2021-07-21

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301996 on ClinicalTrials.gov