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 2023/08/21 09:58:51

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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 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 or person

Institute

Osaka Prefecture 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 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

2023 Year 02 Month 17 Day

Last follow-up date

2024 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

2023 Year 08 Month 21 Day



Link to view the page

Value
https://center6.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