UMIN-CTR Clinical Trial

Basic information
Public title	Examine the patient's response and symptom improvement using the Integrated Approach to Symptom Management Model for the patients who has skin toxicity associated with molecularly targeted drug
Acronym	Effect of the Integrated Approach to Symptom Management for skin toxicity associated with molecularly targeted drug
Scientific Title	Examine the patient's response and symptom improvement using the Integrated Approach to Symptom Management Model for the patients who has skin toxicity associated with molecularly targeted drug
Scientific Title:Acronym	Effect of the Integrated Approach to Symptom Management for skin toxicity associated with molecularly targeted drug
Region	Japan

Condition
Condition	skin toxicity associated with molecularly targeted drug
Classification by specialty	Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of the Integrated Approach to Symptom Management (IASM) for the patients who has skin toxicity associated with molecularly targeted drug. The guide book ver.9 for nurse's activity will be used.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	skin condition (adverse events of skin)
Key secondary outcomes	self-efficacy scale for cancer patients Skindex29 self-care ability (scale)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Period: to March 31st 2016 Frequency : 4 times First Intervention: 1)Interview according to guide book. Conduct observation of skin condition. Measure the outcome scales. 2)Understand the symptom experience of the patient and feedback it empathically. 3)Assessment of self-care ability. 4)Share the plan of the intervention. 5)Provide essential knowledge, essential skill, essential nursing support. (use the original pamphlet) 6)Patients will record their symptom and care for themselves. Second and Third Intervention: 1)Listen and understand patient's symptom experience. 2)Positive feedback. 3)Practice the above 3)4)5). Final Intervention: 1)Review and share the process for 6 weeks. 2)Recognize and identify patient's effort and make sure their achievement. 3)Measure the outcome scales.
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	1) Out patients who have skin toxicity associated with Epidermal growth factor receptor (EGFR) inhibitors or multikinase inhibitors. 2) Patients who have the ability to communicate in Japanese and to respond to the questionnaire without any cognitive disability.
Key exclusion criteria	Patients who cannot communicate in Japanese and be described to understand the contents of the questionnaire.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsuko Uchinuno
Organization	University of Hyogo
Division name	College of Nursing
Zip code
Address	13-71 Kitaouji-cho,Akashi,Hyogo,673-8588 JAPAN
TEL	078-925-9435
Email	a_uchinuno@cnas.u-hyogo.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masamichi Fukuda
Organization	University of Hyogo
Division name	College of Nursing
Zip code
Address	13-71 Kitaouji-cho,Akashi,Hyogo,673-8588 JAPAN
TEL	078-925-9434
Homepage URL	http://sm-support.net/
Email	masamichi_fukuda@cnas.u-hyogo.ac.jp

Sponsor
Institute	University of Hyogo
Institute
Department

Funding Source
Organization	Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	京都第二赤十字病院（京都府）、兵庫県立がんセンター（兵庫県）、神戸市医療センター（兵庫県）、姫路医療センター（兵庫県）、兵庫県立塚口病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 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	2015 Year 04 Month 01 Day
Date of IRB	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 01 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

Management information
Registered date	2015 Year 03 Month 27 Day
Last modified on	2020 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019671