UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044785 |
|---|---|
| Receipt number | R000043604 |
| Scientific Title | Fatigue and activity in breast cancer patients undergoing adjuvant chemotherapy; ver.2 Evaluation of nursing intervention to manage fatigue in breast cancer patients undergoing adjuvant chemotherapy |
| Date of disclosure of the study information | 2021/07/09 |
| Last modified on | 2025/03/31 11:42:37 |
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Basic information
Public title
Evaluation of nursing intervention to manage fatigue in breast cancer patients undergoing adjuvant chemotherapy
Acronym
Nursing intervention to manage fatigue in breast cancer patients undergoing adjuvant chemotherapy
Scientific Title
Fatigue and activity in breast cancer patients undergoing adjuvant chemotherapy; ver.2 Evaluation of nursing intervention to manage fatigue in breast cancer patients undergoing adjuvant chemotherapy
Scientific Title:Acronym
Nursing intervention to manage fatigue in breast cancer patients undergoing adjuvant chemotherapy
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate a nursing intervention to manage fatigue in breast cancer patients undergoing adjuvant chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fatigue: Cancer fatigue scale(CFS)
Activity: Steps per day
It will be Assessed at 3 time points; baseline, during and after the intervention.
Key secondary outcomes
1.QOL: Quality of Life questionnaire for Cancer Patients Treated with Anticancer Drugs(QOL-ACD)
2.anxiety and depression: Hospital Anxiety and Depression Scale(HADS Japanese version)
3.Self-efficacy: Self-efficacy for advanced cancer(SEAC)
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nursing interventions to promote participant fatigue self-management are conducted in two separate sessions consisting of four steps: learn of fatigue, assess physical condition, cope with fatigue, and expand one's activities.
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Women are eligible who if
; have be diagnosed with breast cancer
; mastectomy / breast conserving surgery planned or completed
; undergoing standard adjuvant chemotherapy and
; give informed consent.
Key exclusion criteria
Excluded women who:
; have activity restrictions due to preexisting illness
; can't speak Japanese and answer questionnaires
; have malnutrition, anemia, or electrolyte abnormalities that affect fatigue
; judged by the attending physician to have problems participating in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Kokufu |
Organization
Faculty of Life Sciences Kumamoto University
Division name
Department of Clinical Nursing
Zip code
862-0976
Address
4-24-1 Kuhonji Kumamoto-shi Kumamoto 862-0976, JAPAN
TEL
096-373-5472
kokufu@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Kokufu |
Organization
Faculty of Life Sciences Kumamoto University
Division name
Department of Clinical Nursing
Zip code
862-0976
Address
4-24-1 Kuhonji Kumamoto-shi Kumamoto 862-0976, JAPAN
TEL
096-373-5472
Homepage URL
kokufu@kumamoto-u.ac.jp
Sponsor or person
Institute
Faculty of Life Sciences Kumamoto 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
Kumamoto University Certified Clinical Research Review Board.
Address
1-1-1 Honjou Kumamoto-shi Kumamoto 860-8556, JAPAN
Tel
096-373-5966
byi-senshin@jimu.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
| 2021 | Year | 07 | Month | 09 | 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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2021 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043604
