UMIN-CTR Clinical Trial

Basic information
Public title	Computer-assisted Mindfulness-based Cognitive Therapy: feasibility study
Acronym	IT-MBCT: feasibility study
Scientific Title	Computer-assisted Mindfulness-based Cognitive Therapy: feasibility study
Scientific Title:Acronym	IT-MBCT: feasibility study
Region	Japan

Condition
Condition	cancer
Classification by specialty	Hematology and clinical oncology Psychiatry
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate feasibility of computer-assisted Mindfulness-based Cognitive Therapy for psychological distress of 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)(before intervention, post-intervention and 4 weeks after termination)
Key secondary outcomes	Edmonton Symptom Assessment Scale (ESAS) Athens Insomnia Scale(AIS) Interview on the experience of the program

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Other
Interventions/Control_1	Computer-assisted Mindfulness-based Cognitive Therapy: 30mins, four to eight session, weekly or fortnightly
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	Male and Female
Key inclusion criteria	Cancer patients who are treated at Keio University Hospital (Department of Neuropsychiatry, Palliative Care Center, or Surgical Department), are able to attend three or more sessions, and have submitted written consent.
Key exclusion criteria	Patients who simultaneously receive other MBCT programs, have severe physical or psychiatric symptoms that may interfere with program attendance, or were denied permission to participate in the program by their physician in charge.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Fujisawa
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	dai_fujisawa@yahoo.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Fujisawa
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	dai_fujisawa@yahoo.co.jp

Sponsor
Institute	Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department

Funding Source
Organization	Japan Hospice Palliative Care Foundation
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	Keio University School of Medicine, Institutional Review Board
Address	35 Shinanomachi, Shinjuku-ku
Tel	03-3353-1211
Email	dfujisawa@keio.jp

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（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 05 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	6
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	2015 Year 10 Month 07 Day
Date of IRB	2015 Year 11 Month 05 Day
Anticipated trial start date	2015 Year 11 Month 07 Day
Last follow-up date	2020 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	2015 Year 11 Month 05 Day
Last modified on	2020 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022711