UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037636 |
|---|---|
| Receipt number | R000042905 |
| Scientific Title | Evaluation of nursing intervention program for promoting to sense of coherence of recurrence breast cancer patients who received chemotherapy |
| Date of disclosure of the study information | 2019/08/15 |
| Last modified on | 2022/02/08 14:59:33 |
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Basic information
Public title
Evaluation of nursing intervention program for promoting to sense of coherence of recurrence breast cancer patients who received chemotherapy
Acronym
Evaluation of nursing intervention for promoting to sense of coherence of recurrence breast cancer patients
Scientific Title
Evaluation of nursing intervention program for promoting to sense of coherence of recurrence breast cancer patients who received chemotherapy
Scientific Title:Acronym
Evaluation of nursing intervention for promoting to sense of coherence of recurrence breast cancer patients
Region
| Japan |
Condition
Condition
recurrence breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effectiveness and usefulness of the nursing intervention program for promote the SOC of breast cancer patients diagnosed with recurrence and undergoing chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anxiety and depression;Hospital Anxiety and Depression Scale
Key secondary outcomes
Sense of coherence;Sense of coherence Scale
Quality of Life;SF-12v2
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
| Other |
Interventions/Control_1
The goal of the program is to improve SOC, to decrease anxiety and depression, and to restore QOL for the patients. The program addresses;support patients to express negative emotions and to sort through emotions and thoughts, assist patients to obtain information of the recurrent cancer and chemotherapy, and support patients to cope constructively with negative emotions. We decided to intervene with the narrative approach. The intervention period was one and a half months from the start of the first chemotherapy, and there were three times interventions.
Interventions/Control_2
Control group;Receive regular care of the nurse at the facility.
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1.A female breast cancer patient who has distant metastasis and undergoing chemotherapy.
2.Chemotherapy includes oral anti-cancer drugs and drip anti-cancer drugs including molecular targeted drugs.
Key exclusion criteria
1.Breast cancer patients with local recurrence
2.Breast cancer patients with first advanced cancer
3.Recurrent breast cancer patients who receive endocrine therapy, radiation therapy, surgery, or immunotherapy alone
4.Patients who have relapsed and are receiving multiple times chemotherapy
5.Patients who appear to be in confusion or panic
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | KUMI |
| Middle name | |
| Last name | SUZUKI |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-0095
Address
7-6, Hatchonishi-machi, Takatsuki, Osaka
TEL
072-684-7281
kumi.suzuki@ompu.ac.jp
Public contact
Name of contact person
| 1st name | KUMI |
| Middle name | |
| Last name | SUZUKI |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-0095
Address
7-6, Hatchonishi-machi, Takatsuki, Osaka
TEL
072-684-7281
Homepage URL
kumi.suzuki@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Medical and Pharmaceutical University hospital
Yodogawa christian hospital
Hyogo prefectural nishinomiya hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-machi, Takatsuki, Osaka
Tel
072-683-1221
rinri@ompu.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
大阪医科薬科大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 25 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 08 | Day |
Last modified on
| 2022 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042905
