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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028692
Receipt No. R000032806
Scientific Title Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Date of disclosure of the study information 2017/08/16
Last modified on 2020/09/14

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Basic information
Public title Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Acronym Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Scientific Title Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Scientific Title:Acronym Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We analyze the nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dermatitis, mucositis, QOL (From beginning of carbon-ion radiotherapy to one year after end of treatment.)
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 radiation dose surface model
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Will irradiation (Carbon-ion) patients at Gunma University.
2)18 years-old <=.
3)There is not the decreased visual acuity that is remarkable before carbon-ion radiotherapy.
4)Performance status is 0-1.
5)The patients who judged A primary doctor to be available for participation in this study.
Key exclusion criteria 1)Dementia is diagnosed
2)By decreases such as eyesight or the hearing ability, a document and oral communication are difficult.
Target sample size 43

Research contact person
Name of lead principal investigator
1st name Yoko
Middle name
Last name Kitada
Organization Gunma University Hospital
Division name Nursing
Zip code 3718511
Address 3-39-15 Showa-machi, Maebashi, Japan
TEL 027-220-8389
Email yokon@gunma-u.ac.jp

Public contact
Name of contact person
1st name Chika
Middle name
Last name Hirai
Organization Gunma University Hospital
Division name Heavy Ion Medical Center
Zip code 3718511
Address 3-39-15 Showa-machi, Maebashi, Japan
TEL 027-220-7890
Homepage URL
Email chikah@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization no date
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Gunma University Hospital
Address 3-39-15 Showa-machi, Maebashi, Japan
Tel 027-220-8740
Email hitotaisho-ciru@ml.gunma-u.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
2017 Year 08 Month 16 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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 19 Day
Date of IRB
2017 Year 05 Month 19 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2020 Year 12 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
2017 Year 08 Month 16 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032806

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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