UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023501 |
|---|---|
| Receipt number | R000027069 |
| Scientific Title | development of a Self-efficacy Scale for Self-management of skin reacton induced by cancer chemotherapy |
| Date of disclosure of the study information | 2016/08/08 |
| Last modified on | 2021/06/07 09:30:41 |
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Basic information
Public title
development of a Self-efficacy Scale for Self-management of skin reacton induced by cancer chemotherapy
Acronym
development of a Self-efficacy Scale for Self-management of skin reacton
Scientific Title
development of a Self-efficacy Scale for Self-management of skin reacton induced by cancer chemotherapy
Scientific Title:Acronym
development of a Self-efficacy Scale for Self-management of skin reacton
Region
| Japan |
Condition
Condition
breast cancer, gastroenterological cancer
Classification by specialty
| Gastrointestinal surgery | Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is development the scale speccifically for measuring self-efficacy for self-management f skin reaction induced by cancer chemotherapy.
Basic objectives2
Others
Basic objectives -Others
The second purpose of this research is psychometric testing; reliability and validaity of a scale.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The scale of Self-efficacy for Self-management of skin reaction
Key secondary outcomes
QOL scale for skin disease; Skindex29,
Hospital Anxiety and Depression Scale Japanese Version,
General Self-Efficacy Scale
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients going to treat with anti-cancer agents and molecular targeted drugs that cause skin reaction in the high frequency as a side effect, Patients who can speak/read/write Japanese, Patients who thier physician determines that the possible cooperation of the survey, Patinets who agree with participation in the study
Key exclusion criteria
Severe physical symptoms of the disease and treatment, Severe psychiatric symptoms such as anxiety and depression, Decline in cognitive function, Life expectancy within a few weeks
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Komatsu |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo, 1608582, Japan
TEL
03-5363-3733
hkomatsu@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Tamura |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokyo, 1608582, Japan
TEL
03-5363-2189
Homepage URL
norry@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Faculty of Nursing and Medical Care
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Keio University School of Medicine Ethics Committee
Address
35, Shinanomachi, Shinjuku-ku, Tokyo,JAPAN
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2016 | Year | 08 | Month | 08 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
We will request to answer questionnaire when patients visit outpatient. The contents of the questionnaire are self-efficacy scale to develop in this research, Skindex29, HADS Japanese version, and general self-efficacy scale.
Management information
Registered date
| 2016 | Year | 08 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027069
