UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047865 |
|---|---|
| Receipt number | R000054571 |
| Scientific Title | Web questionnaire survey on cancer cachexia: J-EPOCC2 |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/03/27 09:02:16 |
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Basic information
Public title
Web questionnaire survey on cancer cachexia: J-EPOCC2
Acronym
J-EPOCC2: Japanese Evidence for Patients Of Cancer Cachexia2
Scientific Title
Web questionnaire survey on cancer cachexia: J-EPOCC2
Scientific Title:Acronym
J-EPOCC2: Japanese Evidence for Patients Of Cancer Cachexia2
Region
| Japan |
Condition
Condition
Cancer cachexia
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is 1.to investigate the level of understanding on cancer cachexia, and 2.to investigate the awareness of the problem for anorexia associated with Cancer
Basic objectives2
Others
Basic objectives -Others
opinion survey
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Daily assessment and measurement of anorexia and weight loss associated with cancer
2) Treatment status for anorexia and weight loss
3) Understanding and treatment status of cancer cachexia diagnostic criteria
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
Doctor who treats cancer patient of drug treatment stage of any of lung, gastric, esophageal, colorectal, liver, biliary, pancreatic cancer in more than 5 cases in the last 3 months
Medical staff such as nurses, pharmacists, nutritionist and physical therapists who are involved in cancer treatment (except nurses who work in clinics and clinics)
Patients with lung,gastric, esophageal, colorectal, liver, biliary, or pancreatic cancer who have been admitted to a medical institution for cancer treatment within one year and have a history of hospitalization.
For patients who have lung, gastric, esophageal, colorectal, liver, biliary or pancreatic cancer and who have been hospitalized or visited a medical institution for cancer treatment within one year, Family of over 20 years old
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Kinoshita |
Organization
Ono Pharmaceutical CO, LTD
Division name
Primary Medical , Medical Affairs
Zip code
541-8564
Address
8-2,Kyuutaromachi 1-chome, Chuo-ku osaka-shi, Osaka
TEL
06-6263-2992
f.kinoshita@ono.co.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Sasaki |
Organization
Reno Medical K.K
Division name
Account Executive
Zip code
104-0061
Address
Nittetsu Kobiki Building,16-3, Ginza 7-chome, Chuo-ku, Tokyo
TEL
03-6859-3421
Homepage URL
research_support@reno.co.jp
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Maimi Kiguchi
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation Shintoukai Yokohamaminoru Clinic IRB
Address
13-8, Betsusho 1-Chome Minami-ku Yokohama-shi, Kanagawa
Tel
045-722-8655
yminoru-irb@eps.co.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
| 2022 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
-
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38449402/
Number of participants that the trial has enrolled
1948
Results
It has been revealed that nearly half of cancer patients do not consult healthcare professionals about loss of appetite or weight loss during treatment. The most common reasons for not seeking help were not considering it necessary to consult and believing that consulting would not lead to improvement. Compared with the Web questionnaire survey in 2019(JEPOCC), there has been little change in awareness of appetite loss and weight loss among patients and their families.
Results date posted
| 2024 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Physicians; doctors with a record of having examined five or more patients with lung, stomach, esophageal, colorectal, liver, biliary tract, or pancreatic cancer in the past three months.
Medical staff; Pharmacists, nurses, physical therapists, and dietitians involved in cancer treatment (excluding nurses working in clinics or medical offices).
Patients; Individuals aged 20 or older who have been diagnosed with lung, stomach, esophageal, colorectal, liver, biliary tract, or pancreatic cancer and have been hospitalized or received outpatient treatment for cancer in the past year.
Family member; Individuals aged 20 or older who reside with a patient diagnosed with lung, stomach, esophageal, colorectal, liver, biliary tract, or pancreatic cancer and have been hospitalized or received outpatient treatment for cancer in the past year.
Participant flow
Doctors and medical staff registered with m3.com, as well as patients and families registered with survey panels (such as research panels) affiliated with Cosmoplan Co., Ltd between June 8 and 23, 2022.
Adverse events
No record found
Outcome measures
Patients:Did you experience loss of appetite or weight loss during cancer treatment?
Patients:What do you think is the major cause of loss of appetite or weight loss during cancer treatment?
Patients/Family/Healthcare professionals:Are you familiar with the term cancer cachexia?
Patients:Did you face any difficulties due to loss of appetite or weight loss?
Family:Have you noticed any impact on the individual with cancer in your family due to loss of appetite or weight loss?
Patients:Did you report or consult with doctors or nurses about loss of appetite or weight loss during cancer treatment?
Patients:What were the reasons for not seeking help?
Healthcare professionals:What is the most common trigger for recognizing loss of appetite or weight loss in cancer patients for the first time?
Healthcare professionals:What kind of condition do you associate with the term cancer cachexia?
Healthcare professionals:Were you aware of the stages and criteria for determining for progression of cancer cachexia?
Physicians:How many cancer cachexia patients do you recall among those treated in the past three months?
Healthcare professionals:What do you consider important regarding the challenges in the diagnosis and treatment of cancer cachexia?
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | 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
None
Management information
Registered date
| 2022 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054571
