UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055138 |
|---|---|
| Receipt number | R000062976 |
| Scientific Title | Adverse Event Monitoring by electronic PRO-CTCAE / CTCAE Recording in Outpatients Treated with Anticancer Agents: An Observational Study |
| Date of disclosure of the study information | 2024/08/02 |
| Last modified on | 2025/06/03 18:03:11 |
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Basic information
Public title
Adverse Event Monitoring by electronic PRO-CTCAE / CTCAE Recording in Outpatients Treated with Anticancer Agents: An Observational Study
Acronym
SMART-PRO Study
Scientific Title
Adverse Event Monitoring by electronic PRO-CTCAE / CTCAE Recording in Outpatients Treated with Anticancer Agents: An Observational Study
Scientific Title:Acronym
SMART-PRO Study
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, adverse events during anticancer treatment will be electronically collected using the Common Terminology Criteria for Adverse Events (CTCAE) and Patient Reported Outcome (PRO)-CTCAE from outpatients with cancer. This information will be shared with healthcare professionals and used in medical care. Previously, adverse events were collected at study sites using paper-based questionnaires. The primary objective of this study is to verify the reliability and timeliness of the electronic collection of adverse events and to simplify the collecting adverse events process. Additionally, since previous studies have shown that PRO-CTCAE complements CTCAE, a secondary objective of this study is to investigate whether electronically collected PRO-CTCAE can also complement CTCAE assessments in Japanese real-world clinical practice.
Basic objectives2
Others
Basic objectives -Others
Safety, and satisfaction of healthcare professionals and patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CG-CAHPS (Consumer Assessment of Healthcare Providers and Systems Clinician & Group Survey) Japanese version at 6 and 12 weeks.
Key secondary outcomes
Satisfaction of healthcare professionals at 12 weeks
Proportion of patients who responded to the electronic PRO
EORTC QLQ-C30 at 12 weeks
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Malignancy diagnosis
ECOG performance status is 0-2
Age 20 years or older at time of consent
Prognosis expected to be greater than 6 months by physician
Written informed consent
Patient is able to use a smartphone
Key exclusion criteria
Patients who are clearly unable to use touch screen electronic devices for data entry.
Patients who are clearly unable to self-report their symptoms due to mental illness or cognitive impairment.
Patients participating in other PRO studies during the same time period, which would interfere with their participation in this study's ePRO entry.
Other patients deemed inappropriate by the physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shunya |
| Middle name | |
| Last name | Ikeda |
Organization
International University of Health and Welfare
Division name
Department of Social Medical Sciences, Graduate School of Medicine
Zip code
286-8686
Address
4-3 Kozunomori, Narita City, Chiba, Japan
TEL
03-5574-3912
shunya@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Higuchi |
Organization
Narita hospital, International University of Health and Welfare
Division name
Department of medical oncology
Zip code
286-8520
Address
852 Hatakeda, Narita City, Chiba, Japan
TEL
0476-35-5600
Homepage URL
higuchi-h@iuhw.ac.jp
Sponsor or person
Institute
Narita hospital, International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kakehashi Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee, International University of Health and Welfare
Address
852 Hatakeda, Narita City, Chiba 286-8520 Japan
Tel
0476-35-5600
rinri_md@iuhw.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
国際医療福祉大学成田病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 02 | 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
30
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
| 2024 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 01 | Day |
Other
Other related information
Interim analyses data will be presented soon
Management information
Registered date
| 2024 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062976
