UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043353 |
|---|---|
| Receipt number | R000049496 |
| Scientific Title | A Study to Validate the Usability, Reliability and Validity of the Modified Barthel Index for Palliative Care Cancer Patients |
| Date of disclosure of the study information | 2021/02/17 |
| Last modified on | 2026/02/24 11:24:46 |
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Basic information
Public title
A Study to Validate the Usability, Reliability and Validity of the Modified Barthel Index for Palliative Care Cancer Patients
Acronym
A Study to Validate the Usability, Reliability and Validity of the Modified Barthel Index for Palliative Care Cancer Patients
Scientific Title
A Study to Validate the Usability, Reliability and Validity of the Modified Barthel Index for Palliative Care Cancer Patients
Scientific Title:Acronym
A Study to Validate the Usability, Reliability and Validity of the Modified Barthel Index for Palliative Care Cancer Patients
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the usability, reliability and validity of the modified Barthel Index (mBI) for use in palliative care patients with cancer.
Basic objectives2
Others
Basic objectives -Others
Usability, Reliability and Validity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The usability of mBI for palliative care patients with cancer.
Inter-rater reliability of the mBI for palliative care patients with cancer.
Concurrent validity of mBI and BI, and mBI and Palliative Performance Scale (PPS) and Australia-modified Karnofsky Performance Status (AKPS) scale for palliative care patients with cancer.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with cancer by pathological or clinical diagnosis
2) In- and out-patients receiving palliative care by palliative care team or at palliative care unit
3)Patients 20 years of age or older
Key exclusion criteria
1) Severe symptom burden or severe cognitive impairment
2) Patients in coma
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Nanako |
| Middle name | |
| Last name | Nishiyama |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto Ward, Osaka City, Osaka
TEL
06-6167-1278
nishiyama-nnk@umin.org
Public contact
Name of contact person
| 1st name | Nanako |
| Middle name | |
| Last name | Nishiyama |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto Ward, Osaka City, Osaka
TEL
06-6167-1278
Homepage URL
nishiyama-nnk@umin.org
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Collaborative Research Grant, Graduate School of Comprehensive Rehabilitation Science, Osaka Prefecture University (November 2020 - March 2021)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nara Gakuen Univrsity
Municipal Higashi Osaka Medical Centre
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee on Research Ethics The Graduate School of Rehabilitation Osaka Metropolitan University
Address
3-7-30, Habikino, HAbikino-shi
Tel
0729502111
nnk.nishiyama@omu.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
市立東大阪医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 17 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The usability of mBI for palliative care patients with cancer.
Inter-rater reliability of the mBI for palliative care patients with cancer.
Concurrent validity of mBI and BI, and mBI and Palliative Performance Scale (PPS) and Australia-modified Karnofsky Performance Status (AKPS) scale for palliative care patients with cancer.
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049496
