Adverse Event Monitoring by electronic PRO-CTCAE / CTCAE Recording in Outpatients Treated with Anticancer Agents: An Observational Study

Adverse Event Monitoring by electronic PRO-CTCAE / CTCAE Recording in Outpatients Treated with Anticancer Agents: An Observational Study - SMART-PRO Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055138

Enrollment

Registered

2024-08-02

Start date

2024-05-07

Completion date

Unknown

Last updated

2026-09-14

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: Malignancy diagnosis ECOG performance status is 0-2 Age 20 years or older at time of consent Prognosis expected to be greater than 6 months by physician Written informed consent Patient is able to use a smartphone

Exclusion criteria

Exclusion criteria: Patients who are clearly unable to use touch screen electronic devices for data entry. Patients who are clearly unable to self-report their symptoms due to mental illness or cognitive impairment. Patients participating in other PRO studies during the same time period, which would interfere with their participation in this study's ePRO entry. Other patients deemed inappropriate by the physician.

Design outcomes

Primary

Measure	Time frame
CG-CAHPS (Consumer Assessment of Healthcare Providers and Systems Clinician & Group Survey) Japanese version at 6 and 12 weeks.	—

Secondary

Measure	Time frame
Satisfaction of healthcare professionals at 12 weeks Proportion of patients who responded to the electronic PRO EORTC QLQ-C30 at 12 weeks	—

Countries

Japan

Contacts

Public ContactHajime Higuchi

Narita hospital, International University of Health and Welfare Department of medical oncology

higuchi-h@iuhw.ac.jp0476-35-5600

Outcome results