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

N/ACompletedNCT07301996

Asan Medical Center166 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

166

Conditions

Solid Cancer

Interventions

Mobile PRODEVICE

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 careOTHER

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Rate of unplanned healthcare utilization per patient

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

Time frame: 12-week intervention period

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12-week intervention period

Data from ClinicalTrials.gov

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