UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022035 |
|---|---|
| Receipt number | R000025402 |
| Scientific Title | Effect of self-monitoring intervention for taste disorder of breast cancer patients undergoing chemotherapy |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/11/28 08:41:54 |
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Basic information
Public title
Effect of self-monitoring intervention for taste disorder of breast cancer patients undergoing chemotherapy
Acronym
Self-monitoring intervention for taste disorder breast cancer patients
Scientific Title
Effect of self-monitoring intervention for taste disorder of breast cancer patients undergoing chemotherapy
Scientific Title:Acronym
Self-monitoring intervention for taste disorder breast cancer patients
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To taste failure with breast cancer patients undergoing chemotherapy, by carrying out a self-monitoring, in order to obtain an indication of the effect of improving breast cancer patient self-efficacy and self-management
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In order to acquire the self-management ability to taste failure
Key secondary outcomes
Improvement of breast cancer patients self-management, self-efficacy, QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients undergoing chemotherapy do self-monitoring of taste every day. Performing the feedback of the self-monitoring on the day of treatment every three weeks. Carry out a questionnaire about the also self-management, self-efficacy, QOL.
Interventions/Control_2
Placebo group self-monitoring is not carried out, carru out a questionnaire about self-management, self-efficacy, QOL in treatment day every three weeks.
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1 Patients undergoing preoperative of postoperative adjuvant therapy on an outpatient basis.
2 We perform regimen that includes a 5FU or taxanes, patients rise to taste failure after initial treatment.
3 Consent, consent was obtained patient.
Key exclusion criteria
1 Patient records and communications is not possible due to Japanese.
2 Patients with recurrent treatment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoko Knada |
Organization
Graduate School Health Sciences, Gunma University
Division name
Appllied Nursing
Zip code
Address
Gunmaken maebasisi syouwamati 3-39-22
TEL
027-220-8929
Kkanda@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taeko Kinjou |
Organization
Gunma university hospital
Division name
Outpatient chemotherapy center
Zip code
Address
Gunmaken maebasisi shouwamati 3-39-15
TEL
027-220-8608
Homepage URL
m15711024@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university hospital
Institute
Department
Personal name
Funding Source
Organization
Graduate School Health Sciences, Gunma University
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
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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 24 | Day |
Last modified on
| 2018 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025402
