Solid Cancer
Conditions
Keywords
Patient reported outcome
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).
Detailed 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.
Interventions
DEVICEMobile 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.
OTHERusual 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
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of unplanned healthcare utilization per patient | 12-week intervention period | the composite of unplanned outpatient visits, emergency departments, visits, or hospitalizations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact on health-related QoL (HRQoL) | 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). |
| Progression-free survival | 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. |
| Overall survival | 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. |
| The proportions of individual components of unplanned healthcare use | 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
| Measure | Time frame | Description |
|---|---|---|
| The rate of supportive medication prescriptions | 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. |
Countries
South Korea
Outcome results
None listed