Electronic PRO-CTCAE for monitoring adverse events of cancer medication and collaboration between community and hospital pharmacists: a prospective observational study

Electronic PRO-CTCAE for monitoring adverse events of cancer medication and collaboration between community and hospital pharmacists: a prospective observational study - PHARE-ONC 01 (Pharmacy and Hospital Alliance on Remote Engagement in Oncology 01) Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056007

Enrollment

270

Registered

2024-11-01

Start date

2024-10-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignancy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients receiving anticancer medications in participating hospitals and receiving medications from participating pharmacies with the following criteria -A diagnosis of malignancy -Outpatients receiving anticancer medications -ECOG Performance Status of 0-2 ->=20 to <100 years of age at the time of consent -Written informed consent -Patients with operable a smartphone or caregiver (etc.) accessible on behalf of the patients

Exclusion criteria

Exclusion criteria: Inappropriate patients with the following reasons as decided by health care professionals -Patients with obvious difficulty using touch-screen electronic devices, or caregivers (etc.) with difficulty using the patient's electronic devices continuously and alternately -Patients with obvious difficulties in assessing their own symptoms due to mental illness or cognitive impairment -Concurrent participation in other PRO studies -Other inappropriate patients as decided by health care professionals

Design outcomes

Primary

Measure	Time frame
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	—

Secondary

Measure	Time frame
Number of patients followed up Proportion of informed consent Proportion of PRO-CTCAE responses Number of adverse events grade 3 or more Number of tracing reports Number of Tokutei Yakuzai Kanri Shido Kasan 2 (specific medication management and consultation surcharge) and Fukuyaku Joho Tou Teikyo-ryo (medication information provision surcharge) Number of Renkei Jujitsu Kasan (coordination system enhancement surcharge) Number of prescription suggestions and providing information made by pharmacists for physicians Satisfaction (healthcare professionals and patients) The Consultation and Relational Empathy (CARE) Measure	—

Measure

Time frame

Number of patients followed up Proportion of informed consent Proportion of PRO-CTCAE responses Number of adverse events grade 3 or more Number of tracing reports Number of Tokutei Yakuzai Kanri Shido Kasan 2 (specific medication management and consultation surcharge) and Fukuyaku Joho Tou Teikyo-ryo (medication information provision surcharge) Number of Renkei Jujitsu Kasan (coordination system enhancement surcharge) Number of prescription suggestions and providing information made by pharmacists for physicians Satisfaction (healthcare professionals and patients) The Consultation and Relational Empathy (CARE) Measure

—

Countries

Japan

Contacts

Public ContactMichiko Yamazaki

International University of Health and Welfare Graduate School Graduate School of Medicine

s08-097my@nms.ac.jp080-3019-7880

Outcome results