An assessment of quality of life using electronic patient-reported outcome (ePRO) in patients receiving second-line chemotherapy for unresectable pancreatic cancer

An assessment of quality of life using electronic patient-reported outcome (ePRO) in patients receiving second-line chemotherapy for unresectable pancreatic cancer - QOL-ePAC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044245

Enrollment

150

Registered

2021-05-21

Start date

2021-09-24

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

Pancreatic cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Diagnosed with invasive pancreatic cancer in cytodiagnosis and biopsy (2) Scheduled to receive 2nd cycle of below-listed outpatient second-line chemotherapy for unresectable advanced or metastatic pancreatic cancer: ? nal-IRI+5-FU/LV ? GEM ? GEM+NPTX (3) Aged 20 years or older at the time of consent (4) Able to handle electronic device by him-/herself or with a little help (5) Consent to participate in the study has been obtained from the patient

Exclusion criteria

Exclusion criteria: (1) Judged ineligible to enroll by principal or sub-investigator (2) Currently receiving 2nd cycle of second-line chemotherapy for unresectable advanced or metastatic pancreatic cancer

Design outcomes

Primary

Measure	Time frame
EQ-5D-5L index values measured during 2 consecutive cycles of the second-line chemotherapy after enrolment, beginning at the first day of the 2nd cycle of the chemotherapy.	—

Secondary

Measure	Time frame
(1) QALD calculated from the EQ-5D-5L index value and EORTC QLQ C-30 global score in the study period. (2) EORTC QLQ-C30 global and domain scores during the study period. (3) Correlation between QOL scores and frequency and severity of adverse events as defined in PRO-CTCAE.	—

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Research Center Comprehensive Support Project for Oncology Research

csp-qol@csp.or.jp03-5287-2636

Outcome results