UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046506 |
|---|---|
| Receipt number | R000053061 |
| Scientific Title | Development and evaluation of a nursing program for promoting self-regulation of lung cancer patients to prevent deterioration of dermatologic toxicity associated with epidermal growth factor receptor-tyrosine kinase inhibitor treatment |
| Date of disclosure of the study information | 2022/01/10 |
| Last modified on | 2024/01/09 14:19:38 |
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Basic information
Public title
Development and evaluation of a nursing program for promoting self-regulation of lung cancer patients to prevent deterioration of dermatologic toxicity associated with epidermal growth factor receptor-tyrosine kinase inhibitor treatment
Acronym
Development and evaluation of a nursing program for promoting self-regulation of lung cancer patients to prevent deterioration of dermatologic toxicity associated with EGFR-TKI treatment
Scientific Title
Development and evaluation of a nursing program for promoting self-regulation of lung cancer patients to prevent deterioration of dermatologic toxicity associated with epidermal growth factor receptor-tyrosine kinase inhibitor treatment
Scientific Title:Acronym
Development and evaluation of a nursing program for promoting self-regulation of lung cancer patients to prevent deterioration of dermatologic toxicity associated with EGFR-TKI treatment
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development and evaluation of a nursing program for promoting self-regulation of lung cancer patients to prevent deterioration of dermatologic toxicity associated with epidermal growth factor receptor-tyrosine kinase inhibitor treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The survey period is pre-intervention / at the start of the survey (T0), immediately after the end of the intervention / 8-12 weeks after the first survey (T1), 1 month after the end of the intervention / 1 month after the end of the second survey (T2). The primary outcomes are Dermatology Life Quality Index, severity of skin disorders, keratin water content, and no interruption or discontinuation of EGFR-TKI.
Key secondary outcomes
The survey period is pre-intervention / at the start of the survey (T0), immediately after the end of the intervention / 8-12 weeks after the first survey (T1), 1 month after the end of the intervention / 1 month after the end of the second survey (T2). The secondary outcomes are self-efficacy scale for cancer patients, skin observation and skin care implementation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Providing knowledge about skin care using materials and practicing skin care methods. During the 12 to 16 weekly survey period, the patient observes the skin condition, measures the keratin water content, and records it in the diary about twice a week. Work to promote self-adjustment
Interventions/Control_2
Work to promote self-regulation twice every 4-6 weeks after the initial intervention
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) It is judged by the medical staff that the physical and mental condition is stable and there is no deterioration of cognitive function.
2) Over 20 years old
3) The attending physician and the nurse in charge judge that it is possible to participate in the research.
4) Communication in Japanese is possible
5) Understand the purpose of this research and obtain consent to participate.
Key exclusion criteria
1) Physical and psychological distress is significant and participation in a nursing program becomes a burden
2) Things that cannot be communicated in Japanese
3) Cognitive function is impaired and self-management of drugs and skin care is difficult
4) Those who do not agree to participate in the research
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshie |
| Middle name | |
| Last name | Tokuoka |
Organization
Osaka Metropolitan University
Division name
School of Nursing
Zip code
583-8555
Address
3-7-30 Habikino Habikino-shi,Osaka
TEL
0729502111
tokuokay@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshie |
| Middle name | |
| Last name | Tokuoka |
Organization
Osaka Metropolitan University
Division name
School of Nursing
Zip code
583-8555
Address
3-7-30 Habikino Habikino-shi,Osaka
TEL
0729502111
Homepage URL
tokuokay@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University School of Nursing
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Research Review Board at Osaka Metropolitan University Graduate School of Nursing
Address
3-7-30 Habikino,Habikino-shi,OSAKA
Tel
0729502111
gr-hab-rinri@omu.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
大阪はびきの医療センター（大阪府）
奈良県立医科大学附属病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053061
