UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050843 |
|---|---|
| Receipt number | R000057935 |
| Scientific Title | Efficacy of Nursing Program to Support Lifestyle with Exercise and Rest for Fatigue in Patients After Neoadjuvant Chemotherapy for Breast Cancer |
| Date of disclosure of the study information | 2023/04/14 |
| Last modified on | 2023/04/13 16:33:43 |
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Basic information
Public title
Development of Nursing Program to Support Lifestyle with Exercise and Rest for Fatigue in Patients After Neoadjuvant Chemotherapy for Breast Cancer
Acronym
Nursing Program to Support Lifestyle with Exercise and Rest for Fatigue in Patients After Neoadjuvant Chemotherapy for Breast Cancer
Scientific Title
Efficacy of Nursing Program to Support Lifestyle with Exercise and Rest for Fatigue in Patients After Neoadjuvant Chemotherapy for Breast Cancer
Scientific Title:Acronym
Effectiveness of Nursing Program to Support Lifestyle with Exercise and Rest for Fatigue in Patients After Neoadjuvant Chemotherapy for Breast Cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effectiveness of a nursing program to support a lifestyle incorporating exercise and rest for fatigue in patients after neoadjuvant chemotherapy for breast cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer Fatigue Scale
Evaluate at the beginning of the intervention, at 6 weeks, at 12 weeks, and 4 weeks after the end of the intervention.
Key secondary outcomes
Quality of life: EORTC QLQ-C30
Physical Activity: Global Physical Activity Questionnaire, Steps, Exercise time
Sleep condition: Pittsburgh Sleep Quality Index, Sleeping time
Evaluate at the beginning of the intervention, at 6 weeks, at 12 weeks, and 4 weeks after the end of the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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
Patients in the intervention group work with the nurse to develop a plan for a life that incorporates exercise and rest (breathing method). The nurse will periodically check on the implementation of the plan for 12 weeks and provide support for continuation.
Interventions/Control_2
Patients in the comparison group receive usual care.
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)More than 4 weeks but less than 12 months after completion of neoadjuvant chemotherapy for breast cancer and surgery.
2)Those who have cancer-related fatigue.
3)Stage III or less and no metastasis.
4)No experience with cancer treatment other than breast cancer.
5)Those who have a smartphone.
6)Have no exercise habits and no regular relaxation and are interested in participating in the study.
7)Have no cognitive decline.
8)Those who are judged by the physician in charge to be capable of participating in the research.
Key exclusion criteria
1)Has a history or current history of cardiovascular disease, respiratory disease, diabetes mellitus, or psychiatric disease.
2)Difficulty in exercise due to musculoskeletal problems.
3)Severe side effects associated with breast cancer treatment.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | TASHIRO |
Organization
Chiba University
Division name
Graduate School of Nursing
Zip code
260-8672
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8672 JAPAN
TEL
043-226-2771
rtashiro@chiba-u.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | TASHIRO |
Organization
Chiba University
Division name
Graduate School of Nursing
Zip code
260-8672
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8672 JAPAN
TEL
043-226-2771
Homepage URL
rtashiro@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
YAMAJI FUMIKO NURSING RESEARCH FUND
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Graduate School of Nursing, Chiba University
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8672 JAPAN
Tel
043-226-2462
kango-rinri@chiba-u.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
| 2023 | Year | 04 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | 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 | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057935
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