UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028692 |
|---|---|
| Receipt number | R000032806 |
| Scientific Title | Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer. |
| Date of disclosure of the study information | 2017/08/16 |
| Last modified on | 2026/01/23 23:58:05 |
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Basic information
Public title
Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Acronym
Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Scientific Title
Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Scientific Title:Acronym
Nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We analyze the nursing intervention and effect of the self-care program using the radiation dose surface model on patients receiving carbon-ion radiotherapy for head and neck cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dermatitis, mucositis, QOL (From beginning of carbon-ion radiotherapy to one year after end of treatment.)
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
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 |
Interventions/Control_1
radiation dose surface model
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
1)Will irradiation (Carbon-ion) patients at Gunma University.
2)18 years-old <=.
3)There is not the decreased visual acuity that is remarkable before carbon-ion radiotherapy.
4)Performance status is 0-1.
5)The patients who judged A primary doctor to be available for participation in this study.
Key exclusion criteria
1)Dementia is diagnosed
2)By decreases such as eyesight or the hearing ability, a document and oral communication are difficult.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Kitada |
Organization
Gunma University Hospital
Division name
Nursing
Zip code
3718511
Address
3-39-15 Showa-machi, Maebashi, Japan
TEL
027-220-8389
yokon@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Hirai |
Organization
Gunma University Hospital
Division name
Heavy Ion Medical Center
Zip code
3718511
Address
3-39-15 Showa-machi, Maebashi, Japan
TEL
027-220-7890
Homepage URL
chikah@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
no date
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
Gunma University Hospital
Address
3-39-15 Showa-machi, Maebashi, Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2017 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S2405632425000654?lid=jua9g5tkojjo&utm_source=braz
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2405632425000654?lid=jua9g5tkojjo&utm_source=braz
Number of participants that the trial has enrolled
47
Results
Radiation dermatitis occurred in 98% of the patients (grades 2-3 in 24%) and oral mucositis in 48% (grades 2-3). The self-care checklist scores improved significantly throughout the latter half of the treatment and post-treatment periods. Self-care frequency did not significantly correlate with adverse event severity, although mouth rinsing frequency tended to increase. Two months after treatment, QOL improved across several domains, particularly mental health.
Results date posted
| 2026 | Year | 01 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was approved by Gunma University Hospital Clinical Research Review Board and registered with the Ethics Review Committee for Medical Research Involving Human Subjects (approval date May 19, 2017; approval no. HS2016-120). All the procedures were conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all the participants before CIRT initiation.
This prospective clinical study included 46 patients diagnosed with malignancies of the head and neck region who were treated with CIRT between July 2017 and December 2019 at our institution.
Participant flow
Prior to CIRT initiation, physicians or nurses explained the risk areas for radiation-induced dermatitis and mucositis using the DSM visualizations. The nurses provided instructions using a standardized booklet describing self-care techniques and precautions. The intervention team included a radiation oncologist for head and neck and nurses from the Heavy Ion Medical Center.
Nursing interviews were conducted at baseline, every week during CIRT, and 1 and 2 months after CIRT. Adverse events were graded using CTCAE version 4.0. Self-care frequency (including face washing, mouth rinsing, and tooth brushing) was recorded by the patients using self-report forms on treatment days and at 1 and 2 months post-CIRT. Nurses reviewed the DSM with patients, identified high-risk areas, and provided personalized feedback based on questionnaire responses.
Adverse events
No adverse events were observed.
Outcome measures
Patient and tumor characteristics.
Self-care check questionnaire.
Quality of life assessment.
self-care frequency.
Incidences and severities of radiation dermatitis and oral mucositis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 05 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 16 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032806
