UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054320 |
|---|---|
| Receipt number | R000060801 |
| Scientific Title | Management of Chemotherapy-Related Adverse Events using a Personal Health Record (PHR) App: feasibility trial |
| Date of disclosure of the study information | 2024/05/12 |
| Last modified on | 2024/05/08 19:27:17 |
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Basic information
Public title
Management of Chemotherapy-Related Adverse Events using a Personal Health Record (PHR) App: feasibility trial
Acronym
Management of Chemotherapy-Related Adverse Events using a Personal Health Record (PHR) App: feasibility trial
Scientific Title
Management of Chemotherapy-Related Adverse Events using a Personal Health Record (PHR) App: feasibility trial
Scientific Title:Acronym
Management of Chemotherapy-Related Adverse Events using a Personal Health Record (PHR) App: feasibility trial
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A feasibility study to validate the utility of a smartphone-based Personal Health Record (PHR) application by outpatients who received cancer chemotherapy, for recording their Patient Reported Outcome (PRO) of symptoms at home and sharing these records with healthcare providers. This approach may facilitate the early detection of adverse events and lead to prompt initiation of appropriate care.
Basic objectives2
Others
Basic objectives -Others
Create a protocol based interdisciplinary adverse event management (PBIM) for the healthcare team and observe the achievement of task sharing.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The assessment of adverse event reporting (the correspondence between adverse events reported by patients and those collected by healthcare providers).
Key secondary outcomes
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) A patient scheduled for outpatient chemotherapy for cancer treatment
2) A patient or their household member who uses a smartphone regularly
3) A patient who intends to keep records of their condition and symptoms from the start of the first course of chemotherapy until the completion of the third course, following registration.
Key exclusion criteria
A patient with cognitive impairment who is unable to comprehend the content of the study
2) A patient deemed unsuitable by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ishida |
| Middle name | |
| Last name | Hiroo |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of Medical Oncology
Zip code
224-8503
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa
TEL
045-949-7000
hishida@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Ishida |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of Medical Oncology
Zip code
224-8503
Address
35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa
TEL
045-949-7000
Homepage URL
hishida@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Showa University Research Administration Center
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-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
| 2024 | Year | 05 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this observational study, the cancer notebook app "Welby My Carte ONC service" (Welby Inc.) will be a mobile application for recording the symptoms of cancer patients undergoing outpatient chemotherapy at home. Healthcare providers will monitor and support cancer patients at home using the medical institution information coordination service "Welby My Carte ONC PRO" and "Welby PRO Connect", sending messages as part of the process.
The following outcome measures will be investigated and analyzed during the period from the start of the first course of chemotherapy after obtaining informed consent to the completion of the third course;
1. The assessment of adverse events (concordance between the patient's symptom recording via the PRO-CTCAE app and healthcare provider assessment)
2. Patient's response to adverse events (compliance with healthcare provider instructions)
3. Patient adherence to app usage
4. The change of EORTC QLQ-C30 (from the start of the first course to the completion of the first course and the third course of chemotherapy)
5. Self-efficacy scale for advanced cancer; SEAC (from the start of the first course to the completion of the third course of chemotherapy)
6. Patients' Perception of Using a PHR App
Management information
Registered date
| 2024 | Year | 05 | Month | 06 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060801
