UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035654 |
|---|---|
| Receipt number | R000040544 |
| Scientific Title | Development of coping management program for dysfunction after radical prostatectomy |
| Date of disclosure of the study information | 2019/01/24 |
| Last modified on | 2021/07/26 23:54:47 |
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Basic information
Public title
Development of coping management program for dysfunction after radical prostatectomy
Acronym
RARP-C Study
Scientific Title
Development of coping management program for dysfunction after radical prostatectomy
Scientific Title:Acronym
RARP-C Study
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a "coping management program for dysfunction after radical prostatectomy" aimed at improving postoperative quality of life for patients undergoing robotic-assisted laparoscopic radical prostatectomy in patients with prostate cancer, and investigate the effect of this program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SF-12 Health Survey
(Preoperative,1.3.6.12 months after surgery)
Key secondary outcomes
Expanded Prostate Cancer Index Composite
Universal Uncertainty in Illness Scale
Urination diary(Incontinence volume)
International Prostate Symptom Score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Program implementation group
(3 months after operation from preoperative)
Interventions/Control_2
Normal care group
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
Key inclusion criteria
Patients who undergoing robotic-assisted laparoscopic radical prostatectomy.
Patients scheduled to visit regularly until 12 months after surgery.
Patients who can write a questionnaire.
The patients who don't have dementia and mental disorders.
Key exclusion criteria
Patients chose other treatments.
(radiotherapy, chemotherapy, etc.)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tamami |
| Middle name | |
| Last name | Taniguchi |
Organization
University of Yamanashi
Division name
Department of Health/Lifestyle Support Nursing
Zip code
409-3898
Address
Yamanashi chuo city Shimokato 1110
TEL
055-273-1111
tamamit@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Tamami |
| Middle name | |
| Last name | Taniguchi |
Organization
University of Yamanashi
Division name
Department of Health/Lifestyle Support Nursing
Zip code
409-3898
Address
Yamanashi chuo city Shimokato 1110
TEL
055-273-1111
Homepage URL
tamamit@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
University of Yamanashi
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
University of Yamanashi
Address
Yamanashi chuo city Shimokato 1110
Tel
055-273-9065
rec-med@yamanashi.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
山梨大学医学部附属病院（山梨県）
杏林大学医学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 24 | 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
86
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
| 2018 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 24 | Day |
Last modified on
| 2021 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040544
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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