UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063601 |
|---|---|
| Receipt number | R000072787 |
| Scientific Title | Evaluation of the Effects of Clinical Meditation on Mental Health in Patients with Cancer |
| Date of disclosure of the study information | 2026/11/12 |
| Last modified on | 2026/11/12 07:13:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the Effects of Clinical Meditation on Mental Health in Patients with Cancer
Acronym
Evaluation of the Effects of Clinical Meditation on Mental Health in Patients with Cancer
Scientific Title
Evaluation of the Effects of Clinical Meditation on Mental Health in Patients with Cancer
Scientific Title:Acronym
Evaluation of the Effects of Clinical Meditation on Mental Health in Patients with Cancer
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of an 8-week Clinical Meditation program for patients with cancer and explore changes in psychological outcomes and participants' experiences.
Basic objectives2
Others
Basic objectives -Others
Feasibility assessment and exploration of psychological outcomes and participants' experiences.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
No single primary outcome was prespecified. The six questionnaire measures listed under secondary outcomes were assessed on an equal, exploratory basis.
Key secondary outcomes
HADS anxiety and depression subscales, Insomnia Severity Index, Brief Fatigue Inventory, FACIT-Sp-12, and the short form of the Extended Posttraumatic Growth Inventory, assessed at baseline, 4 weeks, and 8 weeks. Descriptive feasibility measures include retention, session attendance, meditation practice frequency, and poststudy feedback. Thematic analysis of free-text responses about psychological state and meditation experiences.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
An 8-week Clinical Meditation program comprising a 4-week structured phase with one face-to-face group session (approximately 2 hours), three online group sessions (approximately 30 minutes each), and guided home practice (approximately 15 minutes on days without scheduled sessions), followed by a 4-week self-directed phase with voluntary home practice and one individual online session (approximately 30 minutes). No control group.
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
Patients with cancer aged 20 years or older receiving outpatient care at IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, who were receiving or scheduled to receive pharmacotherapy and provided informed consent.
Key exclusion criteria
Patients with severe psychiatric illness.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Niida |
Organization
The Institute of Medical Science, The University of Tokyo
Division name
Laboratory of Molecular Medicine
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL
03-5449-5237
atusiniida@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Niida |
Organization
The Institute of Medical Science, The University of Tokyo
Division name
Laboratory of Molecular Medicine
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
TEL
03-5449-5237
Homepage URL
atusiniida@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Future Medicine Development Fund, The Institute of Medical Science, The University of Tokyo (private donations)
IRB Contact (For public release)
Organization
Research Ethics Committee for Observational Studies, The Institute of Medical Science, The University of Tokyo
Address
3F, Building 1, 4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
Tel
03-6409-2035
ken-rin@ims.u-tokyo.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
東京大学医科学研究所附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 12 | 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
11
Results
Eleven participants enrolled; 9 (81.8%) completed the 4-week assessment and 8 (72.7%) completed the 8-week assessment. Quantitative analyses included 9 participants (8 with complete data); qualitative analyses included 8. Spiritual well-being and posttraumatic growth showed overall changes (multiplicity-adjusted P=.02 and P=.04). Anxiety, depression, insomnia, and fatigue showed no significant changes. This uncontrolled exploratory pilot study does not establish causal efficacy.
Results date posted
| 2026 | Year | 11 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eleven patients with cancer: colorectal cancer (n=7), gastric cancer (n=2), endometrial cancer (n=1), and duodenal cancer (n=1); stage III-IV. All but one were receiving pharmacotherapy at intervention initiation.
Participant flow
All 11 participants completed baseline assessment and the initial face-to-face session. Two discontinued after the initial session and one after the 4-week assessment; reasons were unconfirmed. Nine completed the 4-week assessment and eight the 8-week assessment.
Adverse events
Outcome measures
HADS anxiety and depression, ISI, BFI, FACIT-Sp-12, and the short form of PTGI-X were assessed at baseline, 4 weeks, and 8 weeks. No single primary outcome was prespecified; all six measures were exploratory. Retention, attendance, practice frequency, poststudy feedback, and thematic analysis of free-text responses were also evaluated.
Plan to share IPD
Quantitative data are available from the corresponding author on reasonable request. Full individual free-text responses are not publicly available to protect participant privacy.
IPD sharing Plan description
The qualitative codebook, theme structure, and deidentified English translations of coded passages are included in manuscript Multimedia Appendix 4. Requests for quantitative data should be directed to the corresponding author.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is registered retrospectively. The first participant provided consent and was enrolled on September 16, 2025.
Management information
Registered date
| 2026 | Year | 11 | Month | 12 | Day |
Last modified on
| 2026 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072787
