UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015477 |
|---|---|
| Receipt number | R000017478 |
| Scientific Title | A study of the effect of the self-care support program created by nurses in order to enhance diet satisfaction for chemotherapy patients with breast cancer who suffer from taste alteration |
| Date of disclosure of the study information | 2014/10/21 |
| Last modified on | 2019/06/02 14:06:03 |
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Basic information
Public title
A study of the effect of the self-care support program created by nurses in order to enhance diet satisfaction for chemotherapy patients with breast cancer who suffer from taste alteration
Acronym
A study of the effect of the self-care support program created by nurses in order to enhance diet satisfaction for chemotherapy patients with breast cancer who suffer from taste alteration
Scientific Title
A study of the effect of the self-care support program created by nurses in order to enhance diet satisfaction for chemotherapy patients with breast cancer who suffer from taste alteration
Scientific Title:Acronym
A study of the effect of the self-care support program created by nurses in order to enhance diet satisfaction for chemotherapy patients with breast cancer who suffer from taste alteration
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect of the intervention for diet satisfaction for taste alteration associated with the chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The satisfaction level of the diet by the taste alteration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
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
The support by the nurse using the brochure about the taste alteration
Interventions/Control_2
Usually support care by the nurse
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
Female
Key inclusion criteria
1.The women who were diagnosed as breast cancer newly.
2.20 years of age or over.
3.The patients who receive chemotherapy ( anthracyclines and taxanes)before or after operation.
4.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
5.The patients who do not have taste alteration and oral complication or dysphagia.
6.The patients who agree with the study and do not have communication disorder.
Key exclusion criteria
1.The patients stage 4 with advanced breast cancer or the patients recurrent with breast cancer.
2.The patients who received chemotherapy previously because of cancer treatment.
3.The patients who received radiotherapy to oral cavity or salivary gland previously.
4.The patients who had operation to oral cavity previously.
5.The patients who take a medicine which contains zinc currently or previously because of taste alteration.
6.The patients with serious renal disease(more than serum Cr 2.0mg/dL), or receive dialysis.
7.The patients with serious liver disease.
8.The patients with hepatic disorder, mental disorder, an oral cavity malignant tumor and the diabetes.
9.The patients who have already taken a supplement which contains zinc or a medicine which contains zinc.
10.Patients who are excluded by the doctor's judgment.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Tanabe |
Organization
Hiroshima University Graduate School of Biomedical & Health Sciences
Division name
Department of Health Care for Adults
Zip code
734-8553
Address
1-2-3 Kasumi, Minamiku-ku, Hiroshima City, Hiroshima prefecture
TEL
082-257-5383
ktanae2@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Sanae |
| Middle name | |
| Last name | Asano |
Organization
Hiroshima University Graduate School of Biomedical & Health Sciences
Division name
Department of Health Care for Adults
Zip code
734-8553
Address
1-2-3 Kasumi, Minamiku-ku, Hiroshima City, Hiroshima prefecture
TEL
082-257-5383
Homepage URL
asano-sanae@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Graduate School of Biomedical & Health Sciences
Institute
Department
Personal name
Funding Source
Organization
YAMAJI FUMIKO NURSING RESERACH FUND
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima Univercity Hospital
Address
1-2-3 Kasumi, Minamiku-ku, Hiroshima City, Hiroshima prefecture
Tel
082-257-5907
kasumi-kenkyu@office.hiroshima-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
| 2014 | Year | 10 | Month | 21 | 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
88
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
| 2014 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2018 | 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
| 2014 | Year | 10 | Month | 20 | Day |
Last modified on
| 2019 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017478
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