UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of physical therapy that focuses on stress coping in cancer patients
Title of the study (Brief title)	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	kobayashi daiyu
Organization	Saitama Medical Center
Division name	Rehabilitation
Address	1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL	049-228-3400
Email	kobayashidaiyu@yahoo.co.jp

Public contact
Name of contact person	kobayashi daiyu
Organization	Saitama Medical Center
Division name	Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011913