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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014608
Receipt No. R000016996
Scientific Title Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients
Date of disclosure of the study information 2014/07/22
Last modified on 2014/07/22

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Basic information
Public title Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients
Acronym Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients
Scientific Title Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients
Scientific Title:Acronym Tele-nursing intervention effect with the aim of QOL improvement and exacerbation prevention effect of post-operative complications of prostate cancer patients
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 By comparing the group receiving only routine practice and group support is performed using a tele-nursing for prostate cancer patients of home care in the post-surgery, tele-nursing measures the changes in QOL and post-operative complications to implement the controlled studies on the effect of.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Expanded Prostate Cancer Index Composite
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Using a system developed for the purpose of providing information for reducing complications in the medical live on after surgery for prostate cancer patients. The contents, I will be monitoring in remote areas of the state's day-to-day complications of the subject. To implement questions of medical treatment in live on and provide information about self-care behavior and adjustment of lifestyle to reduce complications, the consultation responses to the problem.
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

Not applicable
Age-upper limit
70 years-old >
Gender Male
Key inclusion criteria Accept it by receiving a description of the survey
Announcement of the disease
· 70 years
By D'Amico classification, Gleason score is classified as either intermediate risk or low-risk, high-risk group of more than 10
Operative therapy
Key exclusion criteria 70 years of age or older
Locally advanced cancer
Classification in ultra high-risk group at NCCN classification
Distant metastasis And mental disorder
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name SATOH DAISUKE
Organization Miyagi University
Division name School of Nursing
Zip code
Address Kurokawa-gun, Miyagi Prefecture, Taiwa-cho, 1-1 Gakuen
TEL 022-377-8046
Email satohdai@myu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name SATOH DAISUKE
Organization Miyagi University
Division name School of Nursing
Zip code
Address Kurokawa-gun, Miyagi Prefecture, Taiwa-cho, 1-1 Gakuen
TEL 0223778046
Homepage URL
Email satohdai@myu.ac.jp

Sponsor
Institute Miyagi University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 22 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
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 03 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
2014 Year 07 Month 22 Day
Last modified on
2014 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016996

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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