UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051589 |
|---|---|
| Receipt number | R000058859 |
| Scientific Title | Registry Study for Symptom Management and Monitoring By PHR APP in Routine Cancer Care Practice |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/04/02 17:47:17 |
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Basic information
Public title
Registry Study for Symptom Management and Monitoring By PHR APP in Routine Cancer Care Practice
Acronym
Registry Study for Symptom Management and Monitoring By PHR APP in Routine Cancer Care Practice
Scientific Title
Registry Study for Symptom Management and Monitoring By PHR APP in Routine Cancer Care Practice
Scientific Title:Acronym
Oncology PHR Registry
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The registry will evaluate the feasibility and usefulness of symptom monitoring using a Personal Health Record (PHR) application in the daily treatment of cancer. It will also accumulate real world data (RWD) of adverse events and quality of life (QOL) based on patient assessments in routine cancer care, and construct a dataset that can be utilized in various situations.
Basic objectives2
Others
Basic objectives -Others
Registry Research
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility of the use of PHR application
Key secondary outcomes
Frequency of adverse events assessed by PRO-CTCAE by cancer type and treatment
Change in quality of life (EORTC-C30) over time by cancer type and treatment
Usefulness of PHR application
Extent, satisfaction, and usefulness of information assessed by EORTC QLQ - INFO25
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
1) Diagnosed with a malignant tumor
2) 18 years of age or older at the time consent is obtained
3) Use or plan to use a PHR application for symptom management
4) Consent to participate in the study has been obtained in writing or electronically
Key exclusion criteria
1) Patients who have obvious difficulty using the PHR application (with or without assistance from family, staff, etc.)
2) Patients who clearly have difficulty assessing their own symptoms due to psychiatric disorders or cognitive dysfunction.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Goto |
Organization
National Cancer Center Hospital
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045 JAPAN
TEL
03-3542-2511
ygoto@ncc.go.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Makihara |
Organization
National Cancer Center Hospital
Division name
Department of Pharmacy
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045 JAPAN
TEL
03-3542-2511
Homepage URL
reando@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Tokyo
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee at National Cancer Center
Address
2-11-12-403 Tomigaya, Shibuya, Tokyo, Japan
Tel
03-3542-2511
irst@ml.res.ncc.go.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
国立がん研究センター中央病院(東京都)
相良病院(鹿児島県)
小松市民病院(石川県)
竹田綜合病院(福島県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The healthcare provider reviews the symptom information recorded by the patient in the PHR application before or during the consultation. The healthcare provider also uses this information to examine the patient during the consultation, and provides necessary information and guidance. The operation method of symptom monitoring using the PHR application by medical institutions shall be conducted in accordance with the "Welby My Chart ONC "PRO" Welby PRO Connect Specification Manual for Medical Institutions.
Management information
Registered date
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058859
