A registry-based study of prolonged symptomatic adverse events according to electronic Patient-Reported Outcomes (ePRO) in breast cancer patients after adjuvant chemotherapy

A registry-based study of prolonged symptomatic adverse events according to electronic Patient-Reported Outcomes (ePRO) in breast cancer patients after adjuvant chemotherapy - ASTRO study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045422

Enrollment

250

Registered

2021-10-04

Start date

2021-10-18

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

Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. 20 years over 2. Histologically diagnosed with invasive breast cancer 3. Patients who start or end adjuvant chemotherapy 4. Written informed consent 5. Patients who can input data from electronic terminals (smartphones, tablets, etc.) 6. Patients who can understand Japanese

Exclusion criteria

Exclusion criteria: 1. Patients who don't have personal electronic devices(smartphones, tablets, etc.)capable of ePRO 2. History of synchronous or metachronous malignancies 3. Patients with psychiatric illnesses or symptoms that seriously disturbs activities of daily life 4. Patients with dementia that seriously disturbs activities of daily life

Design outcomes

Primary

Measure	Time frame
Evaluation of prolonged symptomatic adverse events using ePRO 1 year after adjuvant chemotherapy (CTCAE 26 Items, PRO-CTCAE 50 Items, CiTAS 18 Items, Appearance etc.)	—

Countries

Japan

Contacts

Public ContactYasuhiro Nakano

Cancer Institute Hospital Department of Pharmacy

yasuhiro.nakano@jfcr.or.jp03-3520-0215

Outcome results