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| ID | Type | Description | Link |
|---|---|---|---|
| CB-2017-B-2 | Other Grant/Funding Number | 2017 Cancer Research Support Project of the Korea Foundation for Cancer Research |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile PRO | Experimental | 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. |
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| Control | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of unplanned healthcare utilization per patient | the composite of unplanned outpatient visits, emergency departments, visits, or hospitalizations. | 12-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12-week intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of supportive medication prescriptions | 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. | 12-week intervention period |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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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.
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| 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. |
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| 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. |
| 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. | 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. | 12-week intervention period |