UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044178