UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043030
Receipt number R000049120
Scientific Title Global Educational Needs Evaluation: Systematic Interprofessional Survey in Cancer Cachexia, a Japanese subset
Date of disclosure of the study information 2021/01/18
Last modified on 2023/02/25 10:00:14

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Basic information

Public title

Global Educational Needs Evaluation, a Japanese subset

Acronym

GENESIS-CC in Japan

Scientific Title

Global Educational Needs Evaluation: Systematic Interprofessional Survey in Cancer Cachexia, a Japanese subset

Scientific Title:Acronym

GENESIS-CC in Japan

Region

Japan North America Europe


Condition

Condition

Malignant tumor

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Hematology and clinical oncology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Breast surgery Obstetrics and Gynecology Pediatrics
Ophthalmology Dermatology Oto-rhino-laryngology
Orthopedics Urology Radiology
Oral surgery Neurosurgery Rehabilitation medicine
Nursing

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To explore the actual educational needs of healthcare professionals regarding cancer cachexia

Basic objectives2

Others

Basic objectives -Others

International comparison of educational needs for cancer cachexia

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Practice gaps

Key secondary outcomes

The actual situation of healthcare professionals on
1. Information on cancer cachexia
2. Recognition of cancer cachexia
3. Practice cancer cachexia care
4. Education on cancer cachexia


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All healthcare professionals involved in the screening, diagnosis, and management of cancer, including physicians, nurses, physical therapists, occupational therapists, speech therapists, dietitians, pharmacists, social workers, and licensed psychologists.

Key exclusion criteria

none

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Hidenori
Middle name
Last name Arai

Organization

National Center for Geriatrics and Gerontology

Division name

President

Zip code

474-8511

Address

7-430, Morioka-cho, Obu city, Aichi, Japan

TEL

0562-46-2311

Email

harai@ncgg.go.jp


Public contact

Name of contact person

1st name Tateaki
Middle name
Last name Naito

Organization

Shizuoka Cancer Center

Division name

Division of Thoracic Oncology

Zip code

411-8777

Address

1007, Shimonagakubo, Nagaizumi, Sunto, Shizuoka, Japan

TEL

055-989-5222

Homepage URL

https://www.scchr.jp/index.html

Email

t.naito@scchr.jp


Sponsor or person

Institute

The Society on Sarcopenia, Cachexia and Wasting Disorders

Institute

Department

Personal name



Funding Source

Organization

Pfizer Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shizuoka Cancer Center

Address

1007, Shimonagakubo, Nagaizumi, Sunto, Shizuoka, Japan

Tel

055-989-5222

Email

t.naito@scchr.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

2021 Year 01 Month 18 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

1407

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

under review

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

2020 Year 12 Month 31 Day

Date of IRB

2021 Year 01 Month 10 Day

Anticipated trial start date

2021 Year 01 Month 18 Day

Last follow-up date

2021 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Distribution method: Society website, newsletters, emails, or social media (including Twitter, Facebook, etc.)

Survey content: A total of 59 questions in the following areas (1) to (5) (anonymous, selective, SurveyMonkey)
(1) Respondent attributes (job title, years of experience, academic society affiliation, etc.), (2) Knowledge of cancer cachexia (definition, diagnosis, treatment, etc.), (3) Actual recognition of cancer cachexia, (4) Actual cancer cachexia care, (5) Actual education of cancer cachexia


Management information

Registered date

2021 Year 01 Month 16 Day

Last modified on

2023 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049120


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name