UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055840 |
|---|---|
| Receipt number | R000063033 |
| Scientific Title | Feasibility of an appearance care implementation support program at Designated Cancer Care Hospitals: A single-arm pre- and post- comparative study - focusing on cancer chemotherapy-induced alopecia- |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2025/05/15 12:37:27 |
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Basic information
Public title
Feasibility of an appearance care implementation support program at Designated Cancer Care Hospitals: A single-arm pre- and post- comparative study - focusing on cancer chemotherapy-induced alopecia-
Acronym
Feasibility of an appearance care implementation support program: Hair loss due to cancer chemotherapy
Scientific Title
Feasibility of an appearance care implementation support program at Designated Cancer Care Hospitals: A single-arm pre- and post- comparative study - focusing on cancer chemotherapy-induced alopecia-
Scientific Title:Acronym
Feasibility of an appearance care implementation support program at Designated Cancer Care Hospitals: A single-arm pre- and post- comparative study - focusing on cancer chemotherapy-induced alopecia-
Region
| Japan |
Condition
Condition
cancer chemotherapy-induced alopecia
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Nursing |
| Not applicable | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of appearance care implementation support program.
Basic objectives2
Others
Basic objectives -Others
Secondary objective:
-Issues in achieving the implementation leaders' behavioral goals
-Status of appearance care behavioral implementation by medical staff
-The use of appearance care and relief of pain for patients with cancer chemotherapy-induced alopecia
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Achievement of the following behavioral goals
Implementation Leader (Manager): Checklist for managers
Implementation Leader (Staff in charge of practical matters): Checklist for staff in charge of practical matters
Key secondary outcomes
Implementation leader: Difficulties in achieving behavioral goals, good examples
Medical staff: Status of appearance care behavior implementation,
Patients: Awareness of alopecia and care for alopecia, distress caused by alopecia
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
The intervention for this study is the appearance care implementation support intervention program. In order for implementation leaders to participate in the "appearance care implementation support intervention program" and to develop systematic appearance care at each hospital, the researchers will carry out the following interventions.
Intervention 1: Training
1) Group and online training for implementation leaders to implement appearance care
Intervention 2: Ongoing support
Researchers will support implementation leaders in identifying specific issues and how to address them while implementing systematic appearance care at each hospital.
A formative evaluation of implementation leaders and medical professionals will be conducted in March 2025 to identify facilitating and inhibiting factors and future priority issues at each hospital, and will continue to be involved until the end of the intervention in July 2025.
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
The subjects of this study were implementation leaders at cancer treatment collaborative hospitals whose directors had given their consent to participate in the study, and their occupations included doctors, pharmacists, nurses, psychologists, and social workers. To evaluate the intervention, medical professionals involved in appearance care under the implementation leader
<Intervention subjects>
Selection criteria: Hospital staff (doctors, pharmacists, nurses, psychologists, social workers) who are motivated to work on improving appearance care as an organization and who meet all of the following criteria
Those who have given written consent to participate in the study
Practitioners and managers in the appearance care department as an organization
Men and women aged 18 years or older at the time of obtaining consent
<Subjects of evaluation by questionnaire survey>
Selection criteria: Observation subjects are those who meet the following criteria
Evaluation subjects 1): Medical professionals working on appearance care under the support of the implementation leader
Evaluation subjects 2): Cancer patients: Cancer patients who have experienced hair loss due to cancer chemotherapy for more than two months
Those who have received cancer chemotherapy that causes hair loss, regardless of treatment regimen
Those who have given written consent to participate in the study
Men and women aged 18 years or older at the time of obtaining consent
Key exclusion criteria
Patient Exclusion Criteria:
1) Patients who the principal investigator judges to be inappropriate for inclusion in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Iino |
Organization
Japan Institute for Health Security, National College of Nursing, Japan
Division name
Faculty of Nursing
Zip code
204-8575
Address
1-2-1 Umezono, Kiyose-shi, Tokyo
TEL
042-495-2211
iinok@adm.ncn.ac.jp
Public contact
Name of contact person
| 1st name | Shigeaki |
| Middle name | |
| Last name | Watanuki |
Organization
Japan Institute for Health Security, National College of Nursing, Japan
Division name
Faculty of Nursing
Zip code
204-8575
Address
1-2-1 Umezono, Kiyose-shi, Tokyo
TEL
042-495-2211
Homepage URL
http://ap-kenkyu.umin.jp/
watanukis@adm.ncn.ac.jp
Sponsor or person
Institute
Japan Institute for Health Security, National College of Nursing japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Japan Institute for Health Security, National College of Nursing, Japan
Address
1-2-1 Umezono, Kiyose-shi, Tokyo
Tel
042-495-2211
watanukis@adm.ncn.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 | 10 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | 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
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063033
