UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027069