UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061234 |
|---|---|
| Receipt number | R000070073 |
| Scientific Title | Validation of the Criterion-Related Validity of "A Tool for Clinical Rehabilitation Staff to Evaluate Life-Goal-Setting Practice for Cancer Survivors" |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/12 11:21:02 |
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Basic information
Public title
Validation of the Criterion-Related Validity of "A Tool for Clinical Rehabilitation Staff to Evaluate Life-Goal-Setting Practice for Cancer Survivors"
Acronym
Validation of the Criterion-Related Validity of "A Tool for Clinical Rehabilitation Staff to Evaluate Life-Goal-Setting Practice for Cancer Survivors"
Scientific Title
Validation of the Criterion-Related Validity of "A Tool for Clinical Rehabilitation Staff to Evaluate Life-Goal-Setting Practice for Cancer Survivors"
Scientific Title:Acronym
Validation of the Criterion-Related Validity of "A Tool for Clinical Rehabilitation Staff to Evaluate Life-Goal-Setting Practice for Cancer Survivors"
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Surgery in general | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the criterion-related validity of the Reengagement Life Goal Assessment Tool for Cancer Survivors (ReGAT-C), a tool for clinical rehabilitation staff to evaluate life-goal-setting practice for cancer survivors.
Basic objectives2
Others
Basic objectives -Others
Validation of the evaluation tool's validity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reengagement Life Goal Assessment Tool for Cancer Survivors: ReGAT-C (Evaluation at discharge)
Key secondary outcomes
Assess the following at discharge
-Care Shared Decision Making-Questionnaire for care providers (SDM-C-provider)
-SMART criteria
-Canadian Occupational Performance Measure (COPM)
-Collaborative Relationship Scale between clients and occupational therapists (CRS)
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
-Participants aged 18 years or older
-Participants hospitalized for cancer treatment, such as surgery, chemotherapy, or radiotherapy
-Participants who have been informed of their cancer diagnosis by a physician
-Participants who received rehabilitation provided by physical therapists and/or occupational therapists for at least 5 days
-Participants who have set life goals
-Participants scheduled for discharge to their home
-Participants who provided informed consent to participate in this study
Key exclusion criteria
-Participants with a prognosis of 6 months or less (terminal stage)
-Participants with dementia, mental disorders, or impaired consciousness
-Participants who are unable to communicate verbally
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuma |
| Middle name | |
| Last name | Ikeuchi |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
7230053
Address
1-1 Gakuen-cho, Mihara-city, Hiroshima
TEL
0848-60-1175
ikeuchi@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Katsuma |
| Middle name | |
| Last name | Ikeuchi |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
7230053
Address
1-1 Gakuen-cho, Mihara-city, Hiroshima
TEL
0848-60-1175
Homepage URL
ikeuchi@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Prefectural University of Hiroshima
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara-city, Hiroshima
Tel
0848-60-1175
ikeuchi@pu-hiroshima.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
| 2026 | Year | 04 | Month | 13 | 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 | 09 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will receive standard treatment and rehabilitation. Outcome measures will be assessed once at the time of discharge.
Management information
Registered date
| 2026 | Year | 04 | Month | 12 | Day |
Last modified on
| 2026 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070073
