Adults with solid tumors or hematologic malignancies receiving or scheduled to receive outpatient systemic anticancer chemotherapy
Conditions
Interventions
ePRO monitoring group: Patients complete weekly PRO-CTCAE assessments via smartphone for 24 weeks. For each patient, 16 symptom items, comprising 30 attribute-level questions, are selected from the va
Sponsors
International University of Health and Welfare
KAKEHASHI Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged >= 20 and < 90 years at informed consent. 2) Diagnosed with a solid tumor or hematologic malignancy. 3) Receiving or scheduled within 1 month to receive outpatient systemic anticancer chemotherapy, including cytotoxic chemotherapy, molecularly targeted therapy, or immune checkpoint inhibitors. 4) Expected to continue treatment and follow-up at the same institution and community pharmacy for >= 12 weeks (>= 3 months). 5) Able to use a smartphone in Japanese, with assistance if needed. 6) ECOG performance status 0-2. 7) Providing written or electronic informed consent.
Exclusion criteria
Exclusion criteria: 1) Receiving hormone therapy alone as outpatient systemic anticancer chemotherapy. 2) Diagnosed with acute leukemia. 3) Planned cancer-directed surgery or stem cell transplantation within 12 weeks of enrollment. 4) Cognitive impairment precluding weekly PRO-CTCAE self-completion, per recruiting pharmacist. 5) Concurrent enrollment in another study collecting PROs returned to healthcare providers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-category change in the EORTC QLQ-C30-derived Overall HRQoL score from baseline to Week 12 (3 months), defined as improved (change >= +5 points), worsened (change <= -5 points), or stable otherwise. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include three-category change in Overall HRQoL score from baseline to Week 24; absolute change in Overall HRQoL score from baseline to Weeks 12 and 24; changes in prespecified EORTC QLQ-C30-derived scores (physical function, symptom control, global health status, and financial difficulties) from baseline to Weeks 12 and 24; overall survival through Week 24; and unplanned chemotherapy discontinuation, hospitalization, or emergency department visits. Pharmacist process metrics include institution and community pharmacist follow-up contacts, tracing reports, pre-consultation interviews, pharmaceutical recommendations to treating physicians, and physician acceptance. Exploratory endpoints include claims activity, health-economic analyses, user-experience surveys, and additional patient-reported metrics such as EQ-5D-5L. | — |
Countries
Japan
Contacts
Public ContactTohru Takebe
KAKEHASHI Inc. Patient Engagement
Outcome results
None listed