UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053843 |
|---|---|
| Receipt number | R000061453 |
| Scientific Title | Psychosocial Effects of Cachexia for Older Adults with Advanced Lung and Gastrointestinal Cancer: An Observational Study |
| Date of disclosure of the study information | 2024/03/14 |
| Last modified on | 2024/03/13 08:01:55 |
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Basic information
Public title
Psychosocial Effects of Cachexia for Older Adults with Advanced Lung and Gastrointestinal Cancer: An Observational Study
Acronym
Psychosocial Effects of Cachexia for Older Adults with Advanced Lung and Gastrointestinal Cancer: An Observational Study
Scientific Title
Psychosocial Effects of Cachexia for Older Adults with Advanced Lung and Gastrointestinal Cancer: An Observational Study
Scientific Title:Acronym
Psychosocial Effects of Cachexia for Older Adults with Advanced Lung and Gastrointestinal Cancer: An Observational Study
Region
| Japan |
Condition
Condition
Cancer cachexia or cancer-associated cachexia
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the psychosocial effect of cancer cachexia and risk factors in older adults with advanced lung or gastrointestinal cancer who are scheduled to receive initial cancer drug therapy.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to determine the psychosocial effect of cancer cachexia and risk factors in older adults with advanced lung or gastrointestinal cancer who are scheduled to receive initial cancer drug therapy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between cancer cachexia and eating-related distress (Baseline, 4-8 weeks, 10-14 weeks)
Key secondary outcomes
1) Association between cancer cachexia and EORTC QLQ-CAX24 (Baseline, 4-8 weeks, 10-14 weeks)
2) Association between cancer cachexia and EORTC QLQ-C30 (Baseline, 4-8 weeks, 10-14 weeks)
3) Association between geriatric assessment and eating-related distress (Baseline, 4-8 weeks, 10-14 weeks)
4) Association between severity of cancer cachexia and eating-related distress (Baseline, 4-8 weeks, 10-14 weeks)
5) Interrelationship between patient characteristics, geriatric assessment, severity of cancer cachexia, mGPS, LSMI, EORTC QLQ-CAX24, EORTC QLQ-C30, eating-related distress(Baseline, 4-8 weeks, 10-14 weeks)
6) Association between severity of cancer cachexia, mGPS, LSMI, EORTC QLQ-CAX24, EORTC QLQ-C30, eating-related distress(Baseline, 4-8 weeks, 10-14 weeks)
7) Interview about distress related to eating and weight loss should be described in a way that does not compromise the patient's intentions. (Baseline, 10-14 weeks)
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) participant was at least 70 years on the date of consent
2) participant was ECOG-PS (Eastern Cooperative Oncology Group Performance Status) of 0-2
3) participant was non-small cell lung cancer or small cell lung cancer at clinical stage III/IV or recurrent after radical surgery/radiotherapy
4) participant was scheduled for initial chemotherapy
5) participant has CT images imaging the third lumbar level
6) participants have given written consent
7) participant was able to read and write Japanese
8) participant was expected to survive at least 12 weeks after the start of treatment.
Key exclusion criteria
1) Participant's weight change in the 6 months prior to enrollment was unknown
2) Participant was scheduled to undergo surgical treatment within 3 months from the time of enrollment
3) Participants with psychiatric or neurological symptoms that make it difficult to complete the questionnaire accurately.
Target sample size
60
Research contact person
Name of lead principal investigator
| 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-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
t.naito@scchr.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-cho, Sunto-gun, Shizuoka, Japan
TEL
0559895222
Homepage URL
t3naito@gmail.com
Sponsor or person
Institute
St. Luke's International University
Shizuoka Cancer Center
Institute
Department
Personal name
Naoko Hayashi
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center Ethical review Board
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun
Tel
0559895222
rinsho-office@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
静岡県立静岡がんセンター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 14 | 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 | 06 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective longitudinal observational study
Management information
Registered date
| 2024 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061453
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| Research case data specifications | |
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| Registered date | File name |
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