Unique ID issued by UMIN | UMIN000043975 |
---|---|
Receipt number | R000049718 |
Scientific Title | A registry study on the usefulness of symptom monitoring by ePRO, and status of adverse events and QoL in cancer practice |
Date of disclosure of the study information | 2021/04/19 |
Last modified on | 2023/04/29 17:57:37 |
A registry study on the usefulness of symptom monitoring by ePRO, and status of adverse events and QoL in cancer practice
RegiPRO study
A registry study on the usefulness of symptom monitoring by ePRO, and status of adverse events and QoL in cancer practice
RegiPRO study
Japan |
Esophageal cancer, gastric cancer, duodenal cancer, colon cancer, pancreatic cancer, cholangiocarcinoma, soft tissue tumor, GIST, neuroendocrine tumor, neuroendocrine cancer, malignant mesoderma, NSCLC, SCLC, breast cancer, etc.
Medicine in general | Hematology and clinical oncology |
Malignancy
NO
The purpose of this study is to evaluate the usefulness of symptom monitoring by ePRO (collection of patient-reported outcomes using electronic devices) in daily cancer treatment in Japan, and to evaluate adverse events and QoL in actual cancer treatment.
Efficacy
Exploratory
Not applicable
Differences in FACT-G baseline and after 3 months in the usual care and ePRO cohorts.
Comparison of regular practice cohort and ePRO practice cohort
EQ-5D-5L baseline and changes after 6 months
Relationship between EQ-5D-5L and FACT-G
PRO-CTCAE baseline and changes after 6 months
Satisfaction with chemotherapy (CTSQ) 3 months after the start of treatment
Cost
Recurrence-free survival, survival
Frequency of unreserved consultations and emergency hospitalizations
Medical practice survey
(Analysis by different cancer types, stages, and regimens)
Baseline for PRO evaluation (PRO-CTCAE, FACT-G, ECOG-PS) and changes over time for 6 months
Frequency of unreserved consultations and emergency hospitalizations
Impact of PRO-CTCAE changes on FACT-G
Examining the relationship between CTCAE and PRO-CTCAE
Differences in changes in FACT-G at baseline and after 6 months at different recall periods of PRO-CTCAE (compare Platform A and Platform B).
Expenses associated with adverse events
ePRO Compliance
Analysis of the elderly
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Usual care cohort
Participants will be monitored for symptoms using the conventional methods (eg, using questionnaires such as the so-called "patient diary") that have been used at each facility.
1. Those with a diagnosis of malignant tumor (esophageal cancer, gastric cancer, duodenal cancer, colon cancer, pancreatic cancer, bile duct cancer, soft tumor, GIST, neuroendocrine tumor, neuroendocrine cancer, malignant mesoderma, NSCLC, SCLC, breast cancer, Others)
2. Those planning the first systemic chemotherapy for 3 months or more
3. ECOG Performance Status is 0-2.
4. 20 years and over
5. Expected prognosis of 6 months or more.
6. Those who can obtain written consent.
ePRO Monitoring Cohort:
Symptom monitoring by ePRO. Patients use electronic devices (smartphones or tablets) to report symptoms from their homes or waiting rooms, and medical professionals refer to the PRO from electronic medical records.
On the electronic medical record dashboard monitor, the ePRO information entered by the patient is displayed in different colors according to the severity, and is displayed in association with the treatment information (anticancer drug) of the electronic medical record.
We will not create a special procedure manual that defines the specific measures taken by medical staff.
It is not a so-called e-alert.
1. Those with a diagnosis of malignant tumor.
2. The primary organ must match the target organ of the implementation level for each facility at that time.
3. Those planning initial systemic chemotherapy for 6 months or longer
4. ECOG Performance Status is 0-2.
5. 20 years and over
6. Expected prognosis of 6 months or more.
7. Those who can obtain written consent.
1. Patients who find it clearly difficult to input using a touch screen electronic device (with or without assistance from family members, staff, etc.)
2. Patients whose symptom evaluation is clearly difficult due to mental illness or cognitive impairment
3. Participating in other PRO studies that burden ePRO input in this study at the same time
4. Others that the principal investigator deems inappropriate
400
1st name | Yoshiki |
Middle name | |
Last name | Horie |
St.Marianna University School of Medicine
Department of Clinical Oncology
216-8511
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
044-977-8111
y.horie@marianna-u.ac.jp
1st name | Yoshiki |
Middle name | |
Last name | Horie |
St.Marianna University School of Medicine
Department of Clinical Oncology
216-8511
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
044-977-8111
y.horie@marianna-u.ac.jp
St.Marianna University School of Medicine
Ministry of Health, Labor and Welfare
Japanese Governmental office
St.Marianna University School of Medicine
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
044-977-8111
c3po@marianna-u.ac.jp
NO
2021 | Year | 04 | Month | 19 | Day |
Unpublished
No longer recruiting
2021 | Year | 02 | Month | 24 | Day |
2021 | Year | 02 | Month | 24 | Day |
2021 | Year | 03 | Month | 08 | Day |
2023 | Year | 03 | Month | 31 | Day |
We will compare the outcomes of the usual practice cohort and the cohort of symptom monitoring using ePRO, which is being implemented sequentially.
2021 | Year | 04 | Month | 19 | Day |
2023 | Year | 04 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049718
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |