UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061943 |
|---|---|
| Receipt number | R000070876 |
| Scientific Title | A Single-Arm Before-and-After Pilot Study of Nurse-Led Empathic Assessment and Individualized Coping Support for Dyspnea in Patients with Advanced Lung Cancer |
| Date of disclosure of the study information | 2026/06/17 |
| Last modified on | 2026/06/17 13:33:56 |
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Basic information
Public title
Pilot Study of Empathic Assessment and Coping Support for Dyspnea in Patients with Advanced Lung Cancer
Acronym
Pilot Study of Dyspnea Support for Patients with Advanced Lung Cancer
Scientific Title
A Single-Arm Before-and-After Pilot Study of Nurse-Led Empathic Assessment and Individualized Coping Support for Dyspnea in Patients with Advanced Lung Cancer
Scientific Title:Acronym
Pilot Study of Dyspnea Support for Patients with Advanced Lung Cancer
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratorily evaluate the feasibility and acceptability of a nurse led nonpharmacological intervention for dyspnea in patients with advanced lung cancer. The intervention includes empathic assessment of symptom experiences, individualized self management support, breathing techniques, and coping strategies provided from hospital discharge through the outpatient period. Outcomes include self efficacy, dyspnea intensity, anxiety and depression, and participants subjective experiences.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in Self-Efficacy Scale for Advanced Cancer score
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nurse led non pharmacological intervention consisting of empathic assessment of dyspnea experiences, assessment of psychosocial factors, breathing techniques, self management support, and individualized coping strategies. The intervention is delivered at hospital discharge, the first outpatient visit, and the second outpatient visit.
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
Patients diagnosed with advanced lung cancer (stage IIIb/IV or recurrent disease) and receiving anticancer drug therapy; patients with subjective dyspnea and a dyspnea score of 2 or higher on the breathlessness item of the questionnaire on ease of daily living at admission; patients scheduled for an outpatient visit approximately 2 weeks after discharge; age 20 years or older; able to provide written informed consent; and able to communicate in Japanese and participate in face to face interviews.
Key exclusion criteria
Patients judged to have difficulty expressing their intentions due to cognitive impairment or disturbance of consciousness.
Patients judged to have marked difficulty participating in the study because of psychiatric disorders or acute psychological symptoms.
Patients with severe comorbidities that are expected to cause acute exacerbation of dyspnea during the study period (e.g., acute exacerbation of interstitial lung disease or severe infection).
Patients considered inappropriate for study participation by the attending physician or the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Sugimura |
Organization
Tokai National Higher Education and Research System Gifu University
Division name
School of Nursing
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
0582933226
sugimura.ayumi.e4@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Sugimura |
Organization
Tokai National Higher Education and Research System Gifu University
Division name
School of Nursing
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
0582933226
Homepage URL
sugimura.ayumi.e4@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethics Committee of the Graduate School of Medicine, Gifu University
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
rinri@t.gifu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2026-24
Org. issuing International ID_1
Ethics Committee of Anjo Kosei Hospital, Aichi Prefectural Welfare Federation of Agricultural Cooperatives
Study ID_2
2026-047
Org. issuing International ID_2
Ethics Committee of the Graduate School of Medicine, Gifu University
IND to MHLW
Institutions
Institutions
安城更生病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 17 | 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
| 2026 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070876
