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Prospective Cohort Study to investigate factors affecting Health Related Quality of Life and the Effectiveness of Symptoms Monitoring via Computer-based Health Evaluation System (CHES) in Patients with Metastatic solid cancers during chemotherapy

Prospective Cohort Study to investigate factors affecting Health Related Quality of Life and the Effectiveness of Symptoms Monitoring via Computer-based Health Evaluation System (CHES) in Patients with Metastatic solid cancers during chemotherapy - PROMISE-KOBE Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000029663
Enrollment
115
Registered
2017-12-01
Start date
2018-01-01
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

Patients with metastatic solid cancer (gastric cancer, colorectal cancer and breast cancer) scheduled for first line chemotherapy (including molecular targeted drug and immune checkpoint inhibitor)

Interventions

None listed

Sponsors

Kobe City Medical Center General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with metastatic solid cancer (gastric cancer, colorectal cancer, breast cancer) 2) Patients who are scheduled for first-line chemotherapy (including molecular targeted drug and immune checkpoint inhibitor) 3) Patients who are going to do chemotherapy at the outpatient chemotherapy unit 4) Patient with ECOG Performance Status of 0 to 2. 5) Patients who are expected to have a prognosis of six months or more 6) Written informed consent, with the understanding that the patient may withdraw consent at any time without prejudice

Exclusion criteria

Exclusion criteria: 1) Patients with serious complications 2) Patients who have clinically problematic mental illness 3) Patients judged inappropriate for enrolment by physician

Design outcomes

Primary

MeasureTime frame
EQ-5D-5L

Secondary

MeasureTime frame
Global Health Status scale in EORTC QLQ-C30 EORTC QLQ-C30(five functional scales and three multi-item symptom scales) EORTC QLQ-CIPN20 Overall survival from the registration date Association between clinicopatholigical factors and HRQOL Association between sociodemographic factors and HRQOL Association between visiting emergency room and HRQOL Association between visiting palliative care unit and HRQOL Association between symptom monitoring via Patient Portal Site and HRQOL

Countries

Japan

Contacts

Public ContactYuichiro Kikawa

Kobe City Medical Center General Hospital Department of Breast Surgery

u-1ro@kcho.jp+81-78-302-4321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026