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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022617
Receipt No. R000026069
Scientific Title The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors- pilot study
Date of disclosure of the study information 2016/06/07
Last modified on 2019/06/18

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Basic information
Public title The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors- pilot study
Acronym The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors- pilot study
Scientific Title The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors- pilot study
Scientific Title:Acronym The Effects of Regulative Music Therapy on Fatigue in Breast Cancer Survivors- pilot study
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 examine effectiveness and feasibility of Regulative Music Therapy (RMT) in breast cancer survivors with fatigue.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cancer Fatigue Scale (CFS)
Key secondary outcomes FACIT-Fatigue
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 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 The experimental group received Regulative Music Therapy session every week, which amounted to twelve sessions of 30-40 minutes.
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

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
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 5

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
Email 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
Email ikeuchi.kaori.74m@st.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization The Kao Foundation for Arts and Sciences
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 06 Month 07 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
2016 Year 06 Month 03 Day
Date of IRB
2016 Year 06 Month 08 Day
Anticipated trial start date
2016 Year 06 Month 17 Day
Last follow-up date
2017 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
2016 Year 06 Month 05 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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