UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016142 |
|---|---|
| Receipt number | 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 09:18:05 |
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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
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
dfujisawa@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018741
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
