UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
A registry study on the usefulness of symptom monitoring by ePRO, and status of adverse events and QoL in cancer practice
Acronym
RegiPRO study
Scientific Title
A registry study on the usefulness of symptom monitoring by ePRO, and status of adverse events and QoL in cancer practice
Scientific Title:Acronym
RegiPRO study
Region
| Japan |
Condition
Condition
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.
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in FACT-G baseline and after 3 months in the usual care and ePRO cohorts.
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Horie |
Organization
St.Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
y.horie@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Horie |
Organization
St.Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
Homepage URL
y.horie@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel
044-977-8111
c3po@marianna-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will compare the outcomes of the usual practice cohort and the cohort of symptom monitoring using ePRO, which is being implemented sequentially.
Management information
Registered date
| 2021 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049718
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
