UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028219 |
|---|---|
| Receipt number | R000032175 |
| Scientific Title | Development of nursing care program to sustain the patients with recurrent lung cancer using "Hope-Design Note" |
| Date of disclosure of the study information | 2017/08/23 |
| Last modified on | 2019/01/17 17:39:55 |
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Basic information
Public title
Development of nursing care program to sustain the patients with recurrent lung cancer using "Hope-Design Note"
Acronym
Development of nursing care program to sustain the patients with recurrent lung cancer using "Hope-Design Note"
Scientific Title
Development of nursing care program to sustain the patients with recurrent lung cancer using "Hope-Design Note"
Scientific Title:Acronym
Development of nursing care program to sustain the patients with recurrent lung cancer using "Hope-Design Note"
Region
| Japan |
Condition
Condition
patients with recurrent lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a nursing care program that sustains the hope of patients with recurrent lung cancer using "Hope-Design Note" and clarify the effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.The patients can express their hope
2.The patients can find the way of life in their future
Key secondary outcomes
1.Evaluation by hope scale:
Herth Hope Index(HHI)
2.Evaluation by QOL scale:
European Organization for Research Treatment of Cancer (EORTC QLQ-C30)
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Session of nursing care program using "Hope-Design Note"
Each session takes 30-60 minutes and we have 2 or 3 sessions.
Session intervention is provided by the researcher using "Hope-Design Note".
Contents of intervention, the patient fills in the answer to the question of "Hope-Design Note".
What to write in the "Hope-Design Note"
1 My family member or close friends and precious things for me
2 What I want to do for my family member or close friends and precious things for me
If it is difficult for the patient to write in "Hope-Design Note", the researcher writes instead.
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 Patient has undergone surgery for lung cancer and received a diagnosis of recurrence
2 Patient can communicate in Japanese
3 Patient and their family know the patient's condition and treatment
4 Patient doesn't have serious cognative disorder and mental disease
5 Patient has physical status to endure examination
Key exclusion criteria
The primary physician estimate that patient cannot participate in the intervention or answer the questionnaire because of his/her physical,mental,or cognitive function.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Yamazaki |
Organization
Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Division name
Nursing Course of End-of Life care and Oncology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3813-5335
ns140012@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisako Sanbe |
Organization
Graduate School of Health Care Sciences, Tokyo Medical and Dental University
Division name
Nursing Course of End-of Life care and Oncology
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-3813-7238
Homepage URL
ns140012@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2017 | Year | 08 | Month | 23 | 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 | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032175
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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