UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056266 |
|---|---|
| Receipt number | R000064285 |
| Scientific Title | Evaluation of the impact of appearance care on QOL for cancer patients |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2024/11/25 15:58:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the impact of appearance care on QOL for cancer patients
Acronym
Evaluation of the impact of appearance care on QOL for cancer patients
Scientific Title
Evaluation of the impact of appearance care on QOL for cancer patients
Scientific Title:Acronym
Evaluation of the impact of appearance care on QOL for cancer patients
Region
| Japan |
Condition
Condition
cancer patients
Classification by specialty
| Medicine in general | Surgery in general | Obstetrics and Gynecology |
| Ophthalmology | Dermatology | Oto-rhino-laryngology |
| Urology | Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether appearance care for skin disorders in patients undergoing cancer treatment improves their quality of life and adherence to treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between subjective evaluation of study subjects and skin condition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
To evaluate the effect of instruction on appearance care (correcting the appearance of skin symptoms using makeup products) for skin problems during cancer treatment on patients' QOL and treatment adherence using questionnaires (changes in QOL and daily behavior/attitude toward cancer treatment).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cancer patients undergoing treatment who have facial skin problems
Key exclusion criteria
(1) Individuals who require prescription medication for skin problems
(2) Individuals who have experienced skin symptoms such as contact dermatitis due to ingredients in the makeup products used in this study or similar ingredients
(3) Individuals who, in principle, cannot be examined at the end of the study
(4) Individuals who are otherwise deemed inappropriate for participation in this study by the co-researchers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Murota |
Organization
Nagasaki University Hospital
Division name
Department of Dermatology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki
TEL
+81-95-819-7333
r-fukuchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Reika |
| Middle name | |
| Last name | Fukuchi |
Organization
Nagasaki University Hospital
Division name
Department of Dermatology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki
TEL
+81-95-819-7333
Homepage URL
r-fukuchi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
TOKIWA Pharmaceutical Co., Ltd.
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki
Tel
+81-95-819-7229
gaibushikin@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064285
