UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024377 |
|---|---|
| Receipt number | R000028067 |
| Scientific Title | Quality of life of the cancer patients with the target therapy induced dermatologic toxicities |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2017/12/15 10:27:14 |
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Basic information
Public title
Quality of life of the cancer patients with the target therapy induced dermatologic toxicities
Acronym
Quality of life of the cancer patients with the target therapy induced dermatologic toxicities
Scientific Title
Quality of life of the cancer patients with the target therapy induced dermatologic toxicities
Scientific Title:Acronym
Quality of life of the cancer patients with the target therapy induced dermatologic toxicities
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess a relationship between the target therapy induced dermatologic toxicities and patients'quality of life
Basic objectives2
Others
Basic objectives -Others
Depression and Anxiety,
The Mental Adjustment to Cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health related quality of life:EQ-5D,
DLQI(Dermatology Life Quality Index)
Key secondary outcomes
Depression and Anxiety: K6
The Mental Adjustment to Cancer scale (MAC)
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)Patient with the target therapy induced dermatologic toxicities (CTCAE Grade 1 or more),
2)Stage and metastasis are no object,
3)Patient who is able to complete to the questionnaire in Japanese,
4)Patient aged 20 or more (no upper age limit).
Key exclusion criteria
1)Patient decided by primary doctor that it's difficult to participate in the research because of current severer physical pain, anxiety, or depression,
2)ECOG performance status of 3 or more,
3)Patient cognitive impairment or mental disorders.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Yagasaki |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-2157
yagasaki@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Yagasaki |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-2157
Homepage URL
yagasaki@sfc.keio.ac.jp
Sponsor or person
Institute
Faculty of Nursing and Medical Care, Keio University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number
JP 15H05081
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Skin toxicity and quality of life
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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 22 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 22 | Day |
Other
Other related information
Depression, Anxiety
Mental Adjustment to Cancer
Management information
Registered date
| 2016 | Year | 10 | Month | 12 | Day |
Last modified on
| 2017 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028067
