UMIN-CTR Clinical Trial

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

Interstitial lung disease and lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hamamatsu university school of medicine

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

09

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2021

Year

09

Month

21

Day

Last modified on

2022

Year

09

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051979