UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057685 |
|---|---|
| Receipt number | R000065917 |
| Scientific Title | An Exploratory Study on Estimating Physical and Mental Health Status and Developing a Novel State Assessment Indicator Based on Daily Rhythms and Medication Data in Cancer Survivors |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/04/22 17:59:45 |
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Basic information
Public title
Estimation of Physical and Mental Health and Development of a Novel State Indicator Based on Daily Rhythms and Medication Data in Cancer Survivors: An Exploratory Study
Acronym
Cancer Lifestyle and Medication-based State assessment
Scientific Title
An Exploratory Study on Estimating Physical and Mental Health Status and Developing a Novel State Assessment Indicator Based on Daily Rhythms and Medication Data in Cancer Survivors
Scientific Title:Acronym
Cancer Lifestyle and Medication-based State Assessment Study
Region
| Japan |
Condition
Condition
Brest Cancer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This exploratory study aims to develop a novel state assessment indicator for cancer survivors by integrating data from wearable devices (capturing daily activity and physiological rhythms), medication records, and self-reported evaluations of physical and mental condition. The goal is to establish an assessment framework that combines objective and subjective measures, thereby supporting personalized health monitoring and improving the quality of life (QoL) in cancer survivorship.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Daily Rhythm Stability Score over a 6-Month Period.
Assessment period: From baseline (Day 0) through approximately Week 24 (6 months), continuously monitored
Description: A rhythm stability score calculated from continuous activity data obtained via wearable devices. Metrics such as 24-hour autocorrelation, coefficient of variation, and day-to-day pattern consistency are used to evaluate changes and intra-individual trends in daily rhythm stability over time.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 45 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
Inclusion Criteria (all must be met):
- Female breast cancer patients who are current members of the Risa-Sana peer support community
- Aged between 45 and 55 years at the time of consent
- Own a smartphone (iPhone or Android) compatible with Fitbit and Withings apps
- Willing to pay a participation fee of 10,000 JPY to cover the cost of Fitbit and a body weight scale
Key exclusion criteria
Exclusion Criteria (any of the following):
- Scheduled hospitalization during the study period
- Currently diagnosed and receiving treatment for a sleep disorder
- Unable to pay the participation fee by the deadline
- History of skin conditions such as contact dermatitis, or allergies to latex, resin, or metals
- Participation in other clinical studies that may interfere with this research during the study period
- Judged by the principal investigator to be otherwise unsuitable for participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Sese |
Organization
Humanome Lab., Inc
Division name
Research and Development Office
Zip code
1040045
Address
2F, SA Tenhouse, 2-4-10 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
050-7103-7823
sesejun@humanome.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Tsuji |
Organization
Humanome Lab., Inc
Division name
Research and Development Office
Zip code
1040045
Address
2F, SA Tenhouse, 2-4-10 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
050-7103-7823
Homepage URL
tsuji.motoko@humanome.jp
Sponsor or person
Institute
Humanome Lab., Inc
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Humanome Lab., Inc
Address
2F, SA Tenhouse, 2-4-10 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel
050-7103-7823
tsuji.motoko@humanome.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
| 2025 | Year | 12 | Month | 31 | 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
100
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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065917
