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

Asan Medical Center

Status: Completed

Conditions: Solid Cancer

Treatments: Device: Mobile PRO; Other: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT07301996

2020-0716

CB-2017-B-2 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Mobile PRO

Experimental group

Description:

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.

Treatment:

Device: Mobile PRO

Control

Sham Comparator group

Description:

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.

Treatment:

Other: usual care