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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010174
Receipt No. R000011913
Scientific Title The effects of physical therapy that focuses on stress coping in cancer patients
Date of disclosure of the study information 2013/03/06
Last modified on 2017/07/03

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Basic information
Public title The effects of physical therapy that focuses on stress coping in cancer patients
Acronym The effects of physical therapy that focuses on stress coping in cancer patients
Scientific Title The effects of physical therapy that focuses on stress coping in cancer patients
Scientific Title:Acronym The effects of physical therapy that focuses on stress coping in cancer patients
Region
Japan

Condition
Condition Malignancy
Classification by specialty
Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study investigates the effects of physical therapy that focuses on stress coping in cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Coping Inventory for Stressful Situations(CISS),Profile of Mood States(POMS) Brief Form
Key secondary outcomes

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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The CISS enforcement group is assessed a POMS Brief Form on the physical therapy starting date and one week later.In addition,The CISS enforcement group is assessed CISS on the physical therapy starting date.After having feedback,first the result is shown to the patient and the physical therapist in charge,and secondly,the physical therapist conducts physical therapy.
Interventions/Control_2 The non CISS enforcement group is assessed a POMS Brief Form on the physical therapy starting date and one week later.In addition,physical therapist conducts normal physical therapy.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The cancer patients receiving physical therapy.
Key exclusion criteria Subjects who have difficulty in fulfilling the questioner by themselves. Subjects who has difficulty in understanding the instructions through verbal communication. Subjects who are predicted to cause the significant fluctuating on vital sign and fatigue. Insecure subjects.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kobayashi daiyu
Organization Saitama Medical Center
Division name Rehabilitation
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 049-228-3400
Email kobayashidaiyu@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name kobayashi daiyu
Organization Saitama Medical Center
Division name Rehabilitation
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 0492283529
Homepage URL
Email kobayashidaiyu@yahoo.co.jp

Sponsor
Institute Saitama Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 埼玉医科大学総合医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 05 Day
Last modified on
2017 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011913

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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