UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046051 |
|---|---|
| Receipt number | R000052563 |
| Scientific Title | Assessing the implementation of electronic Patient Reported Outcome (ePRO) system in real world oncology practice |
| Date of disclosure of the study information | 2021/11/12 |
| Last modified on | 2024/05/15 09:05:32 |
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Basic information
Public title
Assessing the implementation of electronic Patient Reported Outcome (ePRO) system in real world oncology practice
Acronym
CONNECT-ePRO Study
Scientific Title
Assessing the implementation of electronic Patient Reported Outcome (ePRO) system in real world oncology practice
Scientific Title:Acronym
CONNECT-ePRO Study
Region
| Japan |
Condition
Condition
Cancer patients who are receiving chemotherapy at outpatient unit
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of the self-assessment / monitoring system for adverse events and quality of life of cancer treatment by Electronic Patient Reported Outcome (e-PRO) for cancer patients, and to explore the its efficacy.
Basic objectives2
Others
Basic objectives -Others
To clarify the experience of patients and healthcare professionals and the barriers and facilitators in using the ePRO system.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Usability / feasibility outcomes related to implementation
Key secondary outcomes
Number of emergency outpatient visits
Number of adverse events of CTCAE Grade 3 or higher
Number of times of discontinuation/dose reduction of planned cancer drug therapy
Number of times cancer drug therapy was performed
Number of unscheduled hospitalizations
Unscheduled hospitalization days
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cancer drug treatment patients (including postoperative adjuvant therapy and hormone treatment): Mainly gastrointestinal cancer, lung cancer, breast cancer, gynecological tumor, urological tumor, malignant melanoma, cancer of unknown primary origin Targets solid cancers such as rare cancers.
Patients who have been diagnosed with cancer and have been briefed on the name and treatment of the disease
Adult (18 years or older) patients undergoing outpatient anti-cancer therapy
Patients who own smartphones (iPhone, Android, etc.) and use them on a daily basis
Key exclusion criteria
Patients with cognitive dysfunction.
Patients who cannot speak Japanese.
Cases that the researcher deems inappropriate for participating in this study.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Muto |
Organization
Kyoto University Hospital
Division name
Department of Clinical Oncology
Zip code
606-8507
Address
54 Kawaharacho Shogoin Sakyoku Kyoto city
TEL
075-751-4592
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Uneno |
Organization
Kyoto University Hospital
Division name
Department of Clinical Oncology
Zip code
606-8507
Address
54 Kawaharacho Shogoin Sakyoku Kyoto city
TEL
075-751-3518
Homepage URL
yuuneno@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital
Address
54 Kawaharacho Shogoin Sakyoku Kyoto city
Tel
075-751-4748
ethcom@kuhp.kyoto-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 | 11 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.cureus.com/articles/245881-barriers-and-facilitators-to-the-implementation-of-an-electro
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/245881-barriers-and-facilitators-to-the-implementation-of-an-electro
Number of participants that the trial has enrolled
15
Results
Please Refer to Paper URL
Results date posted
| 2024 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please Refer to Paper URL
Participant flow
Please Refer to Paper URL
Adverse events
Please Refer to Paper URL
Outcome measures
Please Refer to Paper URL
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Use of eReQo by study participants and monitor symptoms of healthcare professionals from the administrator screen.
eReQo is a smartphone app equipped with the Japanese version of PRO-CTCAE: Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events and EORTC QLQ C30. Investigate PRO-CTCAE and general physical condition EORTC QLQ C30 questions 29 and 30 should be answered at least once a week, and EORTC QLQ C30 questions 1 to 28 should be answered at least once a month.
Healthcare professionals at each institution can view the data entered by the patient into eReQo from each medical institution through the administrator screen.
In addition, the patient's family can also view the data entered by the patient from the eReQo app, but the specifications cannot be edited.
Management information
Registered date
| 2021 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052563
