UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053273 |
|---|---|
| Receipt number | R000060800 |
| Scientific Title | Efficacy of online mindfulness-based intervention for early breast cancer patients - A randomized-control trial. |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/01/05 14:18:04 |
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Basic information
Public title
Efficacy of online mindfulness-based intervention for early breast cancer patients
Acronym
Efficacy of online mindfulness-based intervention for early breast cancer patients
Scientific Title
Efficacy of online mindfulness-based intervention for early breast cancer patients - A randomized-control trial.
Scientific Title:Acronym
Efficacy of online mindfulness-based intervention for early breast cancer patients - A randomized-control trial.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of online mindfulness program for early breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of HADS scale
Key secondary outcomes
Improvement of FACT-B scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To participate in online-mindfulness program
Interventions/Control_2
Not participating in an online mindfulness program
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1) Patients with early breast cancer (stage 0 to III at initial diagnosis) with no recurrence after surgery
2) Those who can come to the outpatient clinic
3) Age at the time of obtaining consent is 20 years or older and younger than 80 years old
4) Persons who have obtained consent from themselves to participate in this research by online signature
5) Those who can participate in the program for at least 30 minutes at a time, at least 5 times a week
Key exclusion criteria
1) Persons who attending a psychiatric hospital for mental illness
2) Those who have participated in a mindfulness program for 8 weeks or more in the past
3) Those who are engaged in continuous practice such as zazen or meditation for a long period of time (more than half a year)
4) Those who observed breast cancer recurrence during the research period
5) Others who are deemed unsuitable by the research director (or co-researcher)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Matsuda |
Organization
Medical corporation association mammaria, mammaria tsukiji
Division name
Breast surgical oncology
Zip code
1040045
Address
3-7-2, SKY Build.5F, Tsukiji, Chuo-ku, TOKYO
TEL
+81-3-3545-0880
naomatsu@luke.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Matsuda |
Organization
Medical corporation association mammaria, mammaria tsukiji
Division name
Breast surgical oncology
Zip code
1040045
Address
3-7-2, SKY Build.5F, Tsukiji, Chuo-ku, TOKYO
TEL
+81-3-3545-0880
Homepage URL
info@mammaria.jp
Sponsor or person
Institute
Medical corporation association mammaria, mammaria tsukiji
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International Hospital Ethics Review Committee
Address
9-1, Akashi-cho, Chuo-ku, Tokyo, 104-8560 JAPAN
Tel
+81-3-3541-5151
kenkyukikaku@luke.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060800
