UMIN-CTR Clinical Trial

Basic information
Public title	Symptom Relief and Quality of Dying and Death (QODD) in Patients with Interstitial Lung Disease and Lung Cancer: A Multicenter Cross-sectional Study
Acronym	Symptom Relief and Quality of Dying and Death (QODD) in Patients with Interstitial Lung Disease and Lung Cancer: A Multicenter Cross-sectional Study
Scientific Title	Symptom Relief and Quality of Dying and Death (QODD) in Patients with Interstitial Lung Disease and Lung Cancer: A Multicenter Cross-sectional Study
Scientific Title:Acronym	Symptom Relief and Quality of Dying and Death (QODD) in Patients with Interstitial Lung Disease and Lung Cancer: A Multicenter Cross-sectional Study
Region	Japan

Condition
Condition	Interstitial lung disease and lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify differences in the burden of end-of-life distress symptom relief, QODD, and quality of end-of-life care between patients who die of ILD and those who die of lung cancer through a bereaved family questionnaire.
Basic objectives2	Others
Basic objectives -Others	To determine the prevalence of dyspnea symptoms across diseases and the rate of improvement of dyspnea symptoms with intervention among terminal ILD patients and lung cancer patients around their end of life.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Good death inventory (GDI) scores for the "Physical and mental pain relief" domain.
Key secondary outcomes	The average 10-item score of the Good death inventory (GDI) Prevalence of each physical and psychiatric symptom using MSAS scale assessment Improvement rate of dyspnea symptoms

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	Patients who meet all of the following criteria are eligible 1. Patients who died of interstitial lung disease or lung cancer in the respiratory medicine department of the participating institutions. Drug-induced lung injury and radiation pneumonitis are not included in interstitial lung disease in this study. 2. The age of the patient at the time of death is 20 years or older. 3. The age of the bereaved family is 20 years or older.
Key exclusion criteria	Patients who meet any of the following criteria will not be included in this study 1. Death due to adverse events or judged as treatment-related death. 2. The bereaved family (key person, underwriter) cannot be identified. 3. It is considered difficult for the bereaved family to answer questions about the care they received at the end of life due to restricted visitation. 4. The bereaved family is unable to fill out the survey form due to dementia, mental disability, or visual impairment at the time of discharge. 5. Based on the circumstances at the time of discharge and at present, the bereaved family member is mentally unstable, making it undesirable to conduct the study. 6. Implementation of the research is undesirable as a comprehensive judgment by doctors, nurses, and other multidisciplinary professionals due to strong distrust or misunderstanding of the medical care received or extremely poor relationships with medical personnel.
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Suda
Organization	Hamamatsu university school of medicine
Division name	Respiratory Medicine
Zip code	431-3125
Address	1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, 431-3192, Japan.
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Takafumi Middle name Last name Koyauchi
Organization	Hamamatsu university school of medicine
Division name	Respiratory Medicine
Zip code	431-3125
Address	1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, 431-3192, Japan.
TEL	053-435-2263
Homepage URL
Email	t.koya@hama-med.ac.jp

Sponsor
Institute	Hamamatsu university school of medicine
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
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	the ethics board of Hamamatsu university school of medicine
Address	1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka, 431-3192, Japan.
Tel	053-435-2263
Email	rinri@hama-med.ac.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	2021 Year 09 Month 22 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	638
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	No longer recruiting
Date of protocol fixation	2021 Year 08 Month 31 Day
Date of IRB	2021 Year 08 Month 31 Day
Anticipated trial start date	2021 Year 09 Month 01 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The purpose of this study was to evaluate the QODD of ILD patients, and lung cancer patients were set as the control group. The rationale for setting a control group was that palliative care mainly targets malignant diseases and has an integrated model of palliative care that has been developed over many years, and we expected to obtain clinically interpretable findings by comparing patients with lung cancer. A list of 600 cases each of ILD patients and lung cancer patients who meet the eligibility criteria will be compiled, and a research explanation document and self-administered questionnaire will be mailed to the bereaved families of the eligible patients. The questionnaires will be returned to the questionnaire secretariat (to be set up at Tohoku University), and the responses will be analyzed. The questionnaires will be numbered so that they can be anonymized and linked to the patient information obtained from the medical records during analysis. The questionnaire will include an opt-in item in Q1, and a check mark in the "I agree" box. However, if the above box is not checked, but the subsequent questionnaire questions are answered, the consent is considered to have been obtained and the participants will be enrolled in this study. However, if the above option is not checked, but the subsequent questionnaire questions are answered, the consent is considered to have been obtained and the participants will be enrolled in this study. The consent acquisition rate is considered to be approximately 50% based on previous studies. In the enrolled cases, each institution will be requested to survey the medical records regarding patient background and end-of-life interventions. A researcher at each participating institution will read the medical records and fill out a dedicated survey form. The survey will be administered using a survey ID, and no personally identifiable information such as names will be transcribed.

Management information
Registered date	2021 Year 09 Month 21 Day
Last modified on	2022 Year 09 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051979