UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038820 |
|---|---|
| Receipt number | R000044178 |
| Scientific Title | Cross-sectional research of interaction and causal relationship among factors related to dyspnea in patients with cancer |
| Date of disclosure of the study information | 2019/12/09 |
| Last modified on | 2022/06/08 09:13:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Cross-sectional research of interaction and causal relationship among factors related to dyspnea in patients with cancer
Acronym
Cross-sectional research of interaction and causal relationship among factors related to dyspnea in patients with cancer
Scientific Title
Cross-sectional research of interaction and causal relationship among factors related to dyspnea in patients with cancer
Scientific Title:Acronym
Cross-sectional research of interaction and causal relationship among factors related to dyspnea in patients with cancer
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyze the correlation among factors associated with dyspnea in patients with cancer and to estimate the causal relationship theoretically.
Basic objectives2
Others
Basic objectives -Others
The other aim of this study is to explore patients' subjective interpretation of dyspnea.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation and causal relationship among the following factors related to dyspnea in patients with cancer
1. Dyspnea(Numerical Rating Scale (NRS))
2. ECOG PS
3. Hospital Anxiety and Depression Scale
(HADS) Depression subscale
4. HADS Anxiety subscale
5. Somatosensory Amplification Scale
7. Cough(NRS)
8. Pain(NRS)
9. Use of regular opioids for dyspnea
10. Existence of respiratory failure
Key secondary outcomes
Patient characteristics
1. Age
2. Gender
3. SpO2
4. Type of cancer
5. Smoking history
6. The type and dose of opioid over 24 hours before enrollment
7. The causes of dyspnea
8. Palliative Prognostic Index
Patients' subjective interpretation of dyspnea
1. Psychosomatic status during dyspnea
2. The way of self management to improve dyspnea
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Advanced cancer patients with dyspnea NRS more than 3 related to cancer
2. Patients older than 20 years old
3. Patients with informed consent
Key exclusion criteria
1. Patients who can not fill out questionnaires
2. Patients who use ventilator
3. Patients with dyspnea mainly caused by other diseases than cancer (e.g., COPD, asthma, interstitial lung diseases, drug-induced lung injury, bacterial pneumonia)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Matsuda |
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Division name
Department of Psychosomatic Internal Medicine, Supportive and Palliative Care Team
Zip code
591-8555
Address
Nagasone-Cho 1180, Kita-Ku, Sakai City, Osaka
TEL
+81722523021
matsuda.yoshinobu.tx@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | Matsuda |
| Last name | Matsuda |
Organization
National Hospital Organization Kinki-Chuo Chest Medical Center
Division name
Department of Psychosomatic Internal Medicine, Supportive and Palliative Care Team
Zip code
591-8555
Address
Nagasone-Cho 1180, Kita-Ku, Sakai City, Osaka
TEL
0722523021
Homepage URL
matsuda.yoshinobu.tx@mail.hosp.go.jp
Sponsor or person
Institute
Non-Profit Organization JORTC
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Palliative Medicine
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
National Hospital Organization Kinki-Chuo Chest Medical Center
Address
Nagasone-Cho 1180, Kita-Ku, Sakai City, Osaka
Tel
072-252-3021
matsuda.yoshinobu.tx@mail.hosp.go.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
| 2019 | Year | 12 | Month | 09 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 11 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploring dyspnea-related factors using univariate and multivariate regression models and path analysis
Management information
Registered date
| 2019 | Year | 12 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044178
