UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023501
Receipt No. 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 2019/08/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email norry@sfc.keio.ac.jp

Sponsor
Institute Keio University
Faculty of Nursing and Medical Care
Institute
Department

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
Email 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 Enrolling by invitation
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
Date trial data considered complete
Date analysis concluded

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
2019 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.