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Completed

NCT Number: NCT07301996

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

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).

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Key information

Conditions

Solid Cancer

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Rate of unplanned healthcare utilization per patient

    Time frame: 12-week intervention period

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

Secondary outcomes

  1. Impact on health-related QoL (HRQoL)

    Time frame: 12-week intervention period

    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).

  2. Progression-free survival

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

    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.

  3. Overall survival

    Time frame: From the date of starting chemotherapy to the date of death (up to approximately 1 years)

    The time from the date of starting chemotherapy to the date of death from any cause, whichever occurs first.

  4. The proportions of individual components of unplanned healthcare use

    Time frame: 12-week intervention period

    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.

Other outcomes

  1. The rate of supportive medication prescriptions

    Time frame: 12-week intervention period

    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.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Acronym: Mobile PRO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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