UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020812 |
|---|---|
| Receipt number | R000024017 |
| Scientific Title | The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors |
| Date of disclosure of the study information | 2016/01/31 |
| Last modified on | 2016/03/28 17:10:54 |
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Basic information
Public title
The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors
Acronym
The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors
Scientific Title
The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors
Scientific Title:Acronym
The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to assess the efficacy of Regulative Music Therapy (RMT) in breast cancer survivors with fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer Fatigue Scale (CFS)
Key secondary outcomes
FACIT-Fatigue
NRS
Profile of Mood States (POMS)
Hospital Anxiety and Depression Scale (HADS)
Pittsburgh Sleep Quality Index -Japanese version
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
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 experimental group received Regulative Music Therapy session every week, which amounted to twelve sessions of 30-40 minutes.
Interventions/Control_2
no intervention
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) Patients diagnosed with breast cancer
2) Patients aged twenty or over
3) Patients with Performance status score of 0-2
4) Patients with fatigue score (NRS) of 4 or more
5) Patients who have received local and/or adjuvant cancer therapy no less than 6 months ago
6) Patients who do not have breast cancer recurrence
7) Individuals who sign the consent document after explanation of this study
Key exclusion criteria
1) Patients incapable of sitting for more than 45 minutes
2) Patients with cognitive dysfunction or mental disorders
3) Patients with low hemoglobin level (under 10.0 g / dl) ; with hypothyroidism; with hypercalcemia
4) Patients who engage in music activity once or more a week
5) Patients who are considered to be ineligible for the study participation based on the doctor's judgment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuko Nin |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Science
Zip code
Address
53 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3946
nin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Ikeuchi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Human Health Science
Zip code
Address
53 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3946
Homepage URL
ikeuchi.kaori.74m@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Kao Foundation for Arts and Sciences
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2016 | Year | 01 | Month | 31 | 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
| 2016 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 31 | Day |
Last modified on
| 2016 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024017
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
