Tokyo, May 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061721) titled 'Randomized controlled trial of electronic Patient-Reported Outcome Monitoring with Integrated hospital-community pharmaciSt Engagement for diverse outpatient anticancer chemotherapy' on May 29.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - International University of Health and Welfare
Condition:
Condition - Adults with solid tumors or hematologic malignancies receiving or scheduled to receive outpatient systemic anticancer chemotherapy
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate whether pharmacist collaboration through smartphone-based ePRO monitoring improves health-related quality of life (HRQoL), compared with usual care, among patients with diverse cancer types receiving outpatient systemic anticancer chemotherapy.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 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 validated Japanese PRO-CTCAE item library. All responses are transmitted to the designated community pharmacy, and Grade 3 or higher responses are highlighted. The pharmacist reviews the responses and, as needed, contacts, follows up with, and counsels the patient. If a disease- or treatment-related issue is identified, the pharmacist submits a structured tracing report to the treating institution as needed. All actions and physician acceptance status are recorded in the EDC system.
Interventions/Control_2 - Usual care group: Patients receive standard outpatient cancer care for 24 weeks without pharmacist-linked smartphone-based ePRO monitoring. Routine pharmacist services continue without restriction in both groups, and both groups receive standardized baseline education on self-management of common disease- and treatment-related symptoms.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Aged >= 20 and = 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.
Key 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.
Target Size - 880
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 28 Day
Date of IRB - 2026 Year 04 Month 28 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2027 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070638
Disclaimer: Curated by HT Syndication.
