UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059510 |
|---|---|
| Receipt number | R000068073 |
| Scientific Title | Characteristics of Physical Activity According to Activities of Daily Living in Cancer Survivors Attending a Palliative Care Center: A Preliminary Study |
| Date of disclosure of the study information | 2025/10/23 |
| Last modified on | 2025/10/23 10:43:16 |
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Basic information
Public title
Characteristics of Physical Activity According to Activities of Daily Living in Cancer Survivors Attending a Palliative Care Center: A Preliminary Study
Acronym
PA-ADL in Cancer (Pilot)
Scientific Title
Characteristics of Physical Activity According to Activities of Daily Living in Cancer Survivors Attending a Palliative Care Center: A Preliminary Study
Scientific Title:Acronym
OncoPADL-Pilot
Region
| Japan |
Condition
Condition
Cancer Survivors Attending a Palliative Care Center
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To characterize, by Performance Status level, physical activity measures sedentary time, light intensity activity time, moderate to vigorous activity time, and prolonged sedentary bout indices.
Basic objectives2
Others
Basic objectives -Others
To estimate associations between physical activity indicators and physical symptoms.
To determine planning parameters for the definitive trial population standard deviations of physical activity indicators, minimum required measurement days, device wearing adherence, and missing-data rates.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sedentary time per day (1.5 METs or lower, min/day)
Light intensity physical activity time per day (1.6 to 2.9 METs, min/day)
Moderate to vigorous physical activity time per day (3 METs or more, min/day)
Key secondary outcomes
Frequency and duration per day of 30- and 60-minute sedentary bouts
Associations with ESAS-r-J item and total scores (correlations; exploratory regression)
Minimum measurement days: k satisfying ICC(1,k) 0.70 or more
Wear adherence: proportion of days with valid wear time 10 h/day or more
Missing-data rates (within-person and overall)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult cancer outpatients attending the Palliative Care Clinic, Department of Supportive Care, Saitama Medical University International Medical Center
Age 18 years or more
Key exclusion criteria
Deemed by the physician unable to participate or complete the questionnaire
Performance Status 3 or more
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Natsuki |
| Middle name | |
| Last name | Shimizu |
Organization
Saitama Medical University
Division name
Department of Physical Therapy, Faculty of Health and Medical Care
Zip code
350-0496
Address
981, Kawakado, Mroyama, Saitama
TEL
0492951001
natsuki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Natsuki |
| Middle name | |
| Last name | Shimizu |
Organization
Saitama Medical University
Division name
Department of Physical Therapy, Faculty of Health and Medical Care
Zip code
350-0496
Address
981, Kawakado, Mroyama, Saitama
TEL
09099701144
Homepage URL
natsuki@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
FY2025 Faculty of Health and Medical Care Project Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Center for Promotion of Proper Clinical Research, Saitama Medical University International Medical Center
Address
1397-1 Yamane, Hidaka, Saitama, Japan
Tel
0429844523
chikens@saitama-med.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
埼玉医科大学国際医療センター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 23 | 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
| 2025 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preliminary
Management information
Registered date
| 2025 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068073
