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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016947
Receipt No. R000019671
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
Date of disclosure of the study information 2015/04/01
Last modified on 2017/03/31

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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 Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
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
2017 Year 03 Month 31 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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