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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028619
Receipt No. R000032753
Scientific Title Evaluation research on nursing support algorithm for harmonization of social role and treatment of cancer survivor
Date of disclosure of the study information 2017/08/25
Last modified on 2017/08/09

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Basic information
Public title Evaluation research on nursing support algorithm for harmonization of social role and treatment of cancer survivor
Acronym Evaluation of nursing support algorithm for harmony between social role and treatment
Scientific Title Evaluation research on nursing support algorithm for harmonization of social role and treatment of cancer survivor
Scientific Title:Acronym Evaluation of nursing support algorithm for harmony between social role and treatment
Region
Japan

Condition
Condition Cancer patients undergoing external chemotherapy / radiotherapy, care provided nurse
Classification by specialty
Nursing Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Nursing support by nurses involved in outpatient cancer treatment and support by nursing algorithms for harmonizing social roles and treatments (hereinafter referred to as "nursing algorithm support") are continuing social roles of patients,assistance of nurses/Behavior)is different
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nurse: Evaluation of nursing support for social role to target and Patient data: thermometers and troublesome thermometers and turnover rates
Key secondary outcomes * Improve recognition of social role support
* Improve the quality of outpatient nursing

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Algorithm support / regular care
Supporters support and support nursing algorithms that harmonize social roles and treatments. These can help support the situation of the roles of families, workers and local communities and the side effect management by treatment smoothly. Meanwhile, in the control group, care normally undertaken is carried out. Each for two months from before treatment
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Outpatient chemotherapy center
Nurse working in outpatient department and patients who receive chemotherapy treatment and radiation therapy from the first time and those who care
Key exclusion criteria Patient: Person who can not express his / her intention, palliative radiotherapy practitioner
Nurse: Person who is difficult to respond to interview
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoko Kanda
Organization Gunma University Graduate School of Health Sciences
Division name Department of Nursing
Zip code
Address 3-39-22,Showa-machi Maebashi Gunma
TEL 027-220-8929
Email kkanda@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoko Kanda
Organization Gunma University Graduate School of Health Sciences
Division name Department of Nursing
Zip code
Address 3-39-22,Showa-machi Maebashi Gunma
TEL 027-220-8929
Homepage URL
Email kkanda@gunma-u.ac.jp

Sponsor
Institute Gunma University School of Medicine
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization MEXT JSPS KAKENHI Grant-in-Aid

Other related organizations
Co-sponsor Takasaki University of Health and Welfare,Department of Nursing
Gunma Prefectural College of Health Sciences, Department of Nursing
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 群馬大学医学部附属病院(群馬県)
日高病院(群馬県)、藤岡総合病院(群馬県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 25 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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 20 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
2017 Year 08 Month 09 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032753

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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