UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053616 |
|---|---|
| Receipt number | R000061187 |
| Scientific Title | Web-based regulative music therapy for breast cancer survivors with fatigue: the feasibility study |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/11/19 11:03:21 |
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Basic information
Public title
Web-based regulative music therapy for breast cancer survivors with fatigue: the feasibility study
Acronym
Web-based regulative music therapy for breast cancer survivors with fatigue: the feasibility study
Scientific Title
Web-based regulative music therapy for breast cancer survivors with fatigue: the feasibility study
Scientific Title:Acronym
Web-based regulative music therapy for breast cancer survivors with fatigue: the feasibility study
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine feasibility of web-based Regulative Music Therapy for breast cancer survivors with fatigue.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participation rate of subjects during the intervention
Key secondary outcomes
Cancer Fatigue Scale (CFS)
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Web-based Regulative Music Therapy for breast cancer survivors with fatigue (once a week, 10 sessions)
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Women aged 20 or more and less than 65.
Key exclusion criteria
Patients who have difficulty maintaining a sitting position for approximately 45 minutes.
Patients with cognitive dysfunction or mental disorders.
Patients with severe anemia or hypothyroidism.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Nin |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Science
Zip code
606-8507
Address
53 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3946
nin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yamasaki |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Science
Zip code
606-8507
Address
53 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3946
Homepage URL
yamasaki.kaori.8y@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2024 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 05 | 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
| 2024 | Year | 02 | Month | 15 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061187
