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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038820
Receipt No. 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 2019/12/07

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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
Email 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
Email matsuda.yoshinobu.tx@mail.hosp.go.jp

Sponsor
Institute Non-Profit Organization JORTC
Institute
Department

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
Email 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 Preinitiation
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
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 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
2019 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044178

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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