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

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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 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

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

Value
https://center6.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