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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035647
Receipt No. R000040607
Scientific Title A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients
Date of disclosure of the study information 2019/04/01
Last modified on 2019/01/23

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Basic information
Public title A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients
Acronym A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients
Scientific Title A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients
Scientific Title:Acronym A Study on Intervention of Simplified Progressive Muscle Relaxation Method for Insomnia in Cancer Patients
Region
Japan

Condition
Condition cancer
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of simplified progressive muscle relaxation method on insomnia of cancer patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Actigraph
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Simplified Progressive Muscle Relaxation
Interventions/Control_2 control
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
79 years-old >=
Gender Male and Female
Key inclusion criteria Diagnosis is cancer
Symptoms of insomnia exist
Symptoms is stable
No history of mental illness
Key exclusion criteria It is other than selection criteria
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Kondo
Organization Gunma University
Division name Graduate school
Zip code
Address Maebashi Gunma
TEL 027-220-7111
Email yukondo@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Kondo
Organization Gunma University
Division name Graduate school
Zip code
Address Maebashi Gunma
TEL 027-220-7111
Homepage URL
Email yukondo@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
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
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
2019 Year 04 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 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
2019 Year 01 Month 23 Day
Last modified on
2019 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040607

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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