UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024829 |
|---|---|
| Receipt number | R000028577 |
| Scientific Title | Clarification of mastery in patients with advanced colorectal cancer undergoing chemotherapy |
| Date of disclosure of the study information | 2016/11/25 |
| Last modified on | 2017/05/16 09:40:14 |
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Basic information
Public title
Clarification of mastery in patients with advanced colorectal cancer undergoing chemotherapy
Acronym
Mastery of patients with adavanced colorectalccancer
Scientific Title
Clarification of mastery in patients with advanced colorectal cancer undergoing chemotherapy
Scientific Title:Acronym
Mastery of patients with adavanced colorectalccancer
Region
| Japan |
Condition
Condition
advanced Colorectal Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe the Mastery of
patients with advanced colorectal cancer undergoing chemotherapy
Basic objectives2
Others
Basic objectives -Others
Mastery with related facters
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mastery
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Nursing care
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Those who are explained to the physician that colorectal cancer,
the chemotherapy is required.
2)Those who already have finished one more of course.
3)Those who can understand Japanese.
4)Available for interviews 40~60 minutes (as determined by the primary physician and a head nurse).
5)Those who have no problem with cognitive function.
Key exclusion criteria
NO
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Harue Arao |
Organization
Osaka University Graduate School of Medicine,Division of Health
Division name
Area of Nursing sciences
Zip code
Address
1-7 Yamadaoka,Suita,Osaka565-0871,JAPAN
TEL
06(6879)2542
h-arao@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Hatakeyama |
Organization
Osaka University Graduate School of Medicine, Division of Health Sciences
Division name
Cancer Education and Research Center
Zip code
Address
1-7 Yamadaoka,Suita,Osaka565-0871,JAPAN
TEL
06(6879)2611
Homepage URL
akiko.hatakeyama@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine,Division of Health
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
1)Japanese Red Cross Society Kyoto Daini Hospital
2)Ishikawa Prefectural Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 11 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 25 | 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
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2017 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028577
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
