UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028854 |
|---|---|
| Receipt number | R000033027 |
| Scientific Title | Research on utilization of electronic patient's diary for employment support of cancer patients |
| Date of disclosure of the study information | 2017/08/28 |
| Last modified on | 2020/06/10 14:16:58 |
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Basic information
Public title
Research on utilization of electronic patient's diary for employment support of cancer patients
Acronym
Research on utilization of electronic patient's diary for employment support of cancer patients
Scientific Title
Research on utilization of electronic patient's diary for employment support of cancer patients
Scientific Title:Acronym
Research on utilization of electronic patient's diary for employment support of cancer patients
Region
| Japan |
Condition
Condition
febrile neutropenia
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the hypothesis that "use of an electronic patient diary leads to self-care awareness and leads to employment support as FN countermeasures".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Impact on self-care awareness of electronic patient's diary
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
electronic patient's diary
Interventions/Control_2
ordinary care
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
Female
Key inclusion criteria
1)Patients who have received second-grade external chemotherapy (AC therapy)
2)Patients who are over 20 years old and who can enter mobile or enter personal computer
3)Pateints who received sufficient explanation for the participation of this research ans obtained document consent by the free will with sufficient understanding
Key exclusion criteria
Patients who judged that the doctor in charge is inappropriate as the subject
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayo Komoda |
Organization
Division of pharmacy,
Faculty of Pharmaceutical Sciences,
Tokyo university of science
Division name
Department of medical safety
Zip code
Address
2641 Yamazaki,Noda-shi,Chiba
TEL
04-7121-4134
komo1207@rs.noda.tus.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayo Komoda |
Organization
Division of pharmacy, Faculty of Pharmaceutical Sciences, Tokyo university of science
Division name
Department of medical safety
Zip code
Address
2641 Yamazaki,Noda-shi,Chiba
TEL
04-7121-4134
Homepage URL
komo1207@rs.noda.tus.ac.jp
Sponsor or person
Institute
Tokyo university of science
Institute
Department
Personal name
Funding Source
Organization
Tokyo university of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 08 | Month | 28 | 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
| 2016 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2020 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033027
