UMIN-CTR Clinical Trial

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 Prefecture University
Division name	Graduate School of Comprehensive Rehabilitation
Zip code	583-8555
Address	3-7-30, Habilino, Habikino-shi, Osaka
TEL	072-950-2111
Email	nishiyama-nnk@umin.org

Public contact
Name of contact person	1st name Nanako Middle name Last name Nishiyama
Organization	Osaka Prefecture University
Division name	Graduate School of Comprehensive Rehabilitation
Zip code	583-8555
Address	3-7-30, Habilino, Habikino-shi, Osaka
TEL	072-950-2111
Homepage URL
Email	nishiyama-nnk@umin.org

Sponsor
Institute	Osaka Prefecture University
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Committee on Research Ethics The Graduate School of Comprehensive Rehabilitation Osaka Prefecture University
Address	3-7-30, Habikino, HAbikino-shi
Tel	0729502111
Email	n.nishiyama@rehab.osakafu-u.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
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	Enrolling by invitation
Date of protocol fixation	2021 Year 02 Month 09 Day
Date of IRB	2021 Year 02 Month 10 Day
Anticipated trial start date	2021 Year 02 Month 17 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
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	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049496

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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