UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053042 |
|---|---|
| Receipt number | R000060516 |
| Scientific Title | Research on the effectiveness of welfare nails on the quality of life of cancer patients |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/12/09 11:11:41 |
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Basic information
Public title
Research on the effectiveness of welfare nails on the quality of life of cancer patients
Acronym
welfare nails for cancer patients
Scientific Title
Research on the effectiveness of welfare nails on the quality of life of cancer patients
Scientific Title:Acronym
RENAIL trial
Region
| Japan |
Condition
Condition
all kinds of malignant tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Psychosomatic Internal Medicine |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Dermatology |
| Psychiatry | Oto-rhino-laryngology | Urology |
| Neurosurgery | Plastic surgery | Aesthetic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Cancer treatment often results in changes in appearance, such as skin disorders, hair loss and deformed or discoloured nails, due to surgery, drugs and radiotherapy. Changes in appearance associated with cancer treatment, such as hair loss, skin disorders and scarring, were long considered unavoidable in exchange for life, despite being high on the list of patient distress. However, in the modern era of extended patient survival and a marked increase in the number of working patients, appearance-related appearance care has been positioned as a major pillar of supportive care by healthcare professionals for the purpose of continuing and promoting cancer treatment. In fact, the issue of 'appearance' was taken up for the first time in the Third Basic Plan for the Promotion of Cancer Control and Prevention in 2018, which calls for the construction of a society where people can live with dignity and peace of mind, and requires healthcare professionals to provide appropriate support for appearance issues in order to improve patients' quality of life. This study focuses particularly on nail deformity and aims to analyse the psychological impact of welfare nail intervention as appearance care on cancer patients attending the Kumamoto University Hospital Outpatient Chemotherapy Centre in terms of patient QOL, depression and anxiety, and to examine its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Improvements in quality of life measures (DLQI) before and after intervention
Key secondary outcomes
Improvements in quality of life scales (EORTC-QLQ-C30, FACT-G) before and after intervention
Improvement in the Depression and Anxiety Scale (HADS) pre- and post-intervention
Improvement in Nail Disorder Severity Index (NADSI)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
A welfare nail intervention every two weeks for three months, followed by a questionnaire survey and interviews about the psychological impact of the intervention, including quality of life, depression and anxiety. The care nail intervention is not a medical treatment and is considered non-invasive. The psychological investigation falls under the case where sufficient care is taken in the questionnaire-based question survey, such as clearly indicating in advance that it includes contents that may cause psychological distress to the research subjects, and the research subjects can respond or refuse to respond anonymously, and is judged to be slightly invasive overall as this study.
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
Cancer patients attending the Outpatient Chemotherapy Centre of Kumamoto University Hospital who agree to the welfare nail intervention will be included in the study. As a control grouppatients who do not agree to the welfare nail intervention but agree to the questionnaire-based study will also be included in the study.
Key exclusion criteria
Patients who require dermatological treatment for nails, e.g. due to infection, are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | SATOSHI |
| Middle name | |
| Last name | FUKUSHIMA |
Organization
KUMAMOTO UNIVERSITY HOSPITAL
Division name
Dermatology
Zip code
860-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5233
s_fukushima@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | SATOSHI |
| Middle name | |
| Last name | FUKUSHIMA |
Organization
KUMAMOTO UNIVERSITY HOSPITAL
Division name
Dermatology
Zip code
860-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5233
Homepage URL
s_fukushima@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
Tel
096-373-5657
byi-senshin@jimu.kumamoto-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
熊本大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 01 | 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
| 2023 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060516
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
