UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of Mindfulness Class for Cancer Patients
Title of the study (Brief title)	Feasibility study of Mindfulness Class for Cancer Patients
Region	Japan

Condition
Condition	cancer
Classification by specialty	Surgery in general Breast surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To test feasibility of Mindfulness Class for cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hospital Anxiety and Depression Scale (HADS)
Key secondary outcomes	The Impact of Event Scale-Revised (IES-R) Functional Assessment of Cancer Therapy-Breast cancer (FACT-B) Five Facet Mindfulness Questionnaire (FFMQ) Treatment adherence

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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Mindfulness Class
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)clinical diagnoses of cancer 2)performance status PS 0-2 3)estimated prognosis =>1year 4)submission of written informed consent
Key exclusion criteria	1)severe physical or psychiatric symptoms 2)other clinical decisions
Target sample size	15

Research contact person
Name of lead principal investigator	Sunre Park
Organization	Keio University
Division name	Faculty of Nursing and Medicine care
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03(3353)1211
Email	mindfulness.mbct2013@gmail.com

Public contact
Name of contact person	Sunre Park
Organization	Keio University
Division name	Faculty of Nursing and Medicine care
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03(3353)1211
Homepage URL
Email	mindfulness.mbct2013@gmail.com

Sponsor
Institute	Keio University Faculty of Nursing and Medicine care
Institute
Department

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Self funding
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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 01 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2014 Year 09 Month 01 Day
Date of closure to data entry	2014 Year 12 Month 01 Day
Date trial data considered complete	2017 Year 11 Month 01 Day
Date analysis concluded	2017 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 27 Day
Last modified on	2017 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014857