UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016142
Receipt No. R000018741
Scientific Title Mindfulness-based cognitive therapy for patients with cancer
Date of disclosure of the study information 2015/01/07
Last modified on 2020/07/11 (Ver. 9)

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Basic information
Public title Mindfulness-based cognitive therapy for patients with cancer
Acronym MBCT for cancer patients
Scientific Title Mindfulness-based cognitive therapy for patients with cancer
Scientific Title:Acronym MBCT for cancer patients
Region
Japan

Condition
Condition cancer
Classification by specialty
Hematology and clinical oncology Breast surgery Psychiatry
Nursing Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test efficacy of mindfulness-based cognitive therapy for depression, anxiety and fatigue in patients with cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Depression and anxiety, measured by Hospital Anxiety and Depression Scale (HADS)
Key secondary outcomes QoL: Functional Assessment of Cancer Therapy- General(FACT-G)
Spiriuality: Functional Assessment of Cancer Therapy- Spiritual Well-Being(FACIT-Sp)
State of mindfulness: Five Facet Mindfulness Questionnaire(FFMQ)
Fear of cancer recurrence and progression: Concerns about Recurrence Scale-J(CARS-J)
Fatigue: Brief Fatigue Inventory
Health utility score: EuroQoL-5 (EQ-5D)
Salivary amylase concentration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Mindfulness-based cognitive therapy group intervention
Interventions/Control_2 Wait-list 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
75 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients with stage 0 - III breast cancer
2.ECOG Performance Status of 0 to 2
3.Hospital Anxiety and Depression Scale >= 5
4.Clinical prognosis of one year or over
5.Willing to participate MBCT program for more than five sessions
6.Submission of written informed consent
Key exclusion criteria 1.Severe physical or mental symptoms which hamper study participation
2.Past experience of MBCT or MBSR
3.Judgement of primary care provider as ineligible for the study
Target sample size 88

Research contact person
Name of lead principal investigator
1st name Sunre
Middle name
Last name Park
Organization Keio University
Division name Faculty of Nursing and Medical Care
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email spak@sfc.keio.ac.jp

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

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Ethical Committee, Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.ac.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 01 Month 07 Day

Related information
URL releasing protocol https://www.ctr.med.keio.ac.jp/rinri/
Publication of results Partially published

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/32105790/
Number of participants that the trial has enrolled 74
Results 
Significant improvement in depression, anxiety, fear or cancer recurrence, spiritual wellbeing, quality of life and fatigue.
Results date posted
2020 Year 01 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 02 Month 24 Day
Baseline Characteristics 
Patients with Stage I-III Breast Cancer
Participant flow 
Randomized controlled trial with wait-list control
Adverse events 
Participants' subjective symptoms
Outcome measures 
Hospital Anxiety and Depression Scale
Concerns about Recurrence Scare
Functional Assessment of Chronic Illness Therapy Spiritual Wellbeing Scale
Functional Assessment of Cancer Therapy General
Brief Fatigue Inventory
Five Facet Mindfulness Questionnaire
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 10 Month 30 Day
Date of IRB
2014 Year 11 Month 28 Day
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information https://pubmed.ncbi.nlm.nih.gov/32105790/

Management information
Registered date
2015 Year 01 Month 06 Day
Last modified on
2020 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018741