UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051686 |
|---|---|
| Receipt number | R000058927 |
| Scientific Title | Care partnership between recurrent breast cancer patients and nurses who continue to be treated outpatients -Practical Nursing Research Based on Margaret Newman's Theory- |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2026/01/31 15:52:10 |
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Basic information
Public title
Care partnership between recurrent breast cancer patients and nurses who continue to be treated outpatients
-Practical Nursing Research Based on Margaret Newman's Theory -
Acronym
Practical Nursing Research on Patients with Recurrent Advanced Breast Cancer Using Margaret Newman's Theory
Scientific Title
Care partnership between recurrent breast cancer patients and nurses who continue to be treated outpatients
-Practical Nursing Research Based on Margaret Newman's Theory-
Scientific Title:Acronym
Practical Nursing Research on Patients with Recurrent Advanced Breast Cancer Using Margaret Newman's Theory
Region
| Japan |
Condition
Condition
recurrent advanced breast cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In relation to patients with recurrent advanced breast cancer who continue cancer chemotherapy in the outpatient clinic, patients and nurses who have anxiety and fear practice caring partnership care, focusing on nurses' introspection. Clarify the process of teacher change.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
When a person is in a predicament where they cannot survive with their previous way of life, if nurses stand by them through the care of a caring partnership that supports them in recognizing patterns in the person's way of being and finding meaning, patients and their families will be able to stand by. can find a new way of life, and nurses can grow together
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
This is a qualitative study that focuses on the process of nursing, using the research design of practical nursing research based on Newman's theory as a framework and repeated nursing practice and research.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 2 patients diagnosed with recurrent advanced breast cancer by a doctor
2) Unsuitable for surgery and undergoing chemotherapy
3) Be in a physical and mental condition that allows an interview of about 30 minutes
4) It is predicted that the patient will be anxious or distressed after being notified of the name of the disease or condition.
Key exclusion criteria
1) If the performance status (hereinafter referred to as PS) is 3 or higher and the interview is expected to be a physical burden
2) Mental illness or cognitive impairment
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | chikako |
| Middle name | |
| Last name | otsuka |
Organization
Kumamoto University Hospital
Division name
Outpatient Chemotherapy Center
Zip code
8608556
Address
Kumamoto Prefecture Kumamoto City Chuo-ku Honjo 1-1-1
TEL
0963735640
chikako-ootuka@kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | chikako |
| Middle name | |
| Last name | otsuka |
Organization
Kumamoto University Hospital
Division name
Outpatient Chemotherapy Center
Zip code
8608556
Address
Kumamoto Prefecture Kumamoto City Chuo-ku Honjo 1-1-1
TEL
0963735640
Homepage URL
chikako-ootuka@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University Hospital
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
Kumamoto University Hospital
Address
Kumamoto Prefecture Kumamoto City Chuo-ku Honjo 1-1-1
Tel
0963735640
chikako-ootuka@kuh.kumamoto-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
| 2024 | Year | 12 | Month | 31 | 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
3
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 07 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058927
