UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058377 |
|---|---|
| Receipt number | R000066390 |
| Scientific Title | Japanese nationwide survey to DETECT Unmet medical needs of Outpatient-setting Rehabilitation for patients with cancer |
| Date of disclosure of the study information | 2025/07/10 |
| Last modified on | 2025/07/06 13:12:26 |
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Basic information
Public title
Japanese nationwide survey to DETECT Unmet medical needs of Outpatient-setting Rehabilitation for patients with cancer
Acronym
J-DETECTUOR survey
Scientific Title
Japanese nationwide survey to DETECT Unmet medical needs of Outpatient-setting Rehabilitation for patients with cancer
Scientific Title:Acronym
J-DETECTUOR survey
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are: (1) to detect rehabilitation unmet needs according to life stage and treatment type at discharge; and (2) to investigate factors associated with these rehabilitation unmet needs at discharge among hospitalized patients who were prescribed rehabilitation. These findings aim to contribute to the development of evidence and the establishment of outpatient cancer rehabilitation systems.
Basic objectives2
Others
Basic objectives -Others
The objectives of this study are: (1) to detect rehabilitation unmet needs according to life stage and treatment type at discharge; and (2) to investigate factors associated with these rehabilitation unmet needs at discharge among hospitalized patients who were prescribed rehabilitation. These findings aim to contribute to the development of evidence and the establishment of outpatient cancer rehabilitation systems.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective Rehabilitation Needs Questionnaire
Patients self-complete an original rehabilitation needs questionnaire within seven days prior to discharge.
The questionnaire includes Likert-scale items assessing the following: ADL needs at discharge, IADL needs at discharge, social role needs based on life stage at discharge, prioritization among all needs, and preferences regarding rehabilitation after discharge.
Key secondary outcomes
Patient characteristics: age, sex, height, weight, weight loss, presence of long-term care insurance, home environment (e.g., living alone, housing conditions), educational background, employment status, comorbidities
Tumor characteristics: cancer type, clinical stage, presence of bone metastasis with weight-bearing restrictions
Treatment information: type of treatment (e.g., surgery, chemotherapy, chemoradiotherapy), reason for admission, treatment history
Laboratory data: serum albumin, C-reactive protein (CRP)
Muscle strength: handgrip strength
Physical performance: 30-second sit-to-stand test
ADL assessment: Functional Independence Measure (FIM)
Physical symptom assessment: Edmonton Symptom Assessment System-Revised, Japanese version (ESAS-r-J)
Quality of life: EQ-5D-5L
In-hospital rehabilitation data: total number of rehabilitation units, location of sessions, length of hospital stay
Post-discharge rehabilitation follow-up: presence of follow-up, type of facility providing follow-up care
Subjective rehabilitation needs questionnaire
Survival and readmission data obtained from physician medical records after discharge
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
1) Adult patients (18 years or older) for whom cancer treatment has been planned or is currently being administered by a physician
2) Patients who have received or are scheduled to receive cancer treatment during hospitalization (excluding those receiving primarily palliative care)
3) Patients who have been prescribed inpatient rehabilitation
4) Patients for whom a transfer to another hospital has not yet been determined
5) Patients expected to receive at least two days of rehabilitation intervention, including the start date of the intervention
Key exclusion criteria
1) Patients for whom a transfer to another hospital has been decided
2) Patients who declined or expressed a wish to withdraw from participation
3) Individuals deemed unsuitable by the principal investigator for any other reason
Target sample size
1085
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Harada |
Organization
National Cancer Center Hospital East
Division name
Department of Rehabilitation Medicine
Zip code
2778577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
+81-4-7133-1111
tsuyoshi6167@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Yanagisawa |
Organization
National Cancer Center Hospital East
Division name
Department of Rehabilitation Medicine
Zip code
2778577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
+81-4-7133-1111
Homepage URL
tayanag2@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Physical Therapy
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
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
Tel
+81-4-7133-1111
tsharada@east.ncc.go.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
国立がん研究センター東病院（千葉県）
国際医療福祉大学（栃木県）
名古屋大学大学院（愛知県）
関西医科大学（大阪府）
京都大学医学部附属病院（京都府）
島根大学医学部附属病院（島根県）
岡山大学病院（岡山県）
信州大学医学部附属病院（長野県）
北海道がんセンター（北海道）
国際医療福祉大学塩谷病院（栃木県）
名古屋大学医学部附属病院（愛知県）
大阪国際がんセンター（大阪府）
北九州市立医療センター（福岡県）
総合上飯田第一病院（愛知県）
旭川医科大学病院（北海道）
神戸大学医学部附属病院国際がん医療・研究センター（兵庫県）
香川大学医学部附属病院（香川県）
医療法人鉄蕉会亀田総合病院（千葉県）
浜松医療センター（静岡県）
静岡県立静岡がんセンター（静岡県）
筑波大学附属病院（茨城県）
加古川中央市民病院（兵庫県）
湘南東部総合病院（神奈川県）
関西医科大学附属病院（大阪府）
菅間記念病院（栃木県）
市立函館病院（北海道）
東京慈恵会医科大学附属第三病院（東京都）
国際医療福祉大学病院（栃木県）
神戸大学医学部附属病院（兵庫県）
獨協医科大学日光医療センター（栃木県）
天理よろづ相談所病院（奈良県）
北福島医療センター（福島県）
北里大学病院（神奈川県）
日本赤十字社長崎原爆病院（長崎県）
地方独立行政法人栃木県立がんセンター（栃木県）
大阪公立大学（大阪府）
長崎大学大学院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 10 | 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 | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N.P.
Management information
Registered date
| 2025 | Year | 07 | Month | 06 | Day |
Last modified on
| 2025 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066390
