Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

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Age 50 to 80 years who have at least a 20-pack-year smoking history with successful smoking cessation history (stopping smoking for more than 6 months), but less than 15 years

First-degree relatives of lung cancer patients

1. aged more than 50 years
2. age less than 50 years old, but older than the age at diagnosis of the youngest lung cancer proband in the family

Age 50 to 80 years, meet one or more of the following criteria.

1. air-pollution exposed occupations (such as traffic policeman, street cleaners....) for at least 10 years
2. cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir frying, or deep frying in one week \* years cooking.
3. cooking without using ventilation for more than 20 years
4. history of pulmonary tuberculosis and complete anti-tuberculosis treatment with interval more than 5 years before this study

1. Participants belonging to modified Lung RADS category 1 and 2 at baseline screening will undergo the LDCT next year after the discussion with the physicians in charge.
2. Participants with nodules belonging to modified Lung RADS category 3 and 4, growing nodules, or new nodules found on follow-up LDCT scans will undergo repeat CT every 3 to 6 months or be referred for diagnostic workup depending on the size and characteristics of the nodules as the regular clinical practice.
3. Volume doubling time (VDT) will be performed in the special groups with Lung RADS category 3 or 4, but the nodules with solid components ≧ 6mm and \< 9mm. A repeat LDCT scan will be performed around 3 months after the baseline screening.
4. Check total bilirubin, urinary heavy metals, serum tumor marker, including CEA, alpha-fetal protein, etc.
5. Check pulmonary function test.

Low dose computed tomography

GeeChen Chang, MD. PhD

Chong-Jen Yu, MD PhD

Chung-Ping Hsu, MD PhD

Yu-Feng Wei, MD PhD

Inn-Wen Chong, MD PhD

Po-Hao Feng, MD PhD

GEECHEN CHANG, MD, PhD

Chao-Chi Ho, MD PhD

Lung cancer is the leading cause of mortality in the world, and also in Taiwan.Despite the researches and availability in new therapies, it causes the highest mortality and is one of the most preventable cancers as well. Smoking is the most common cause of lung cancer worldwide. Compared to lung cancer in smokers, lung cancer in never-smokers is associated with East Asian ethnicity, female sex, and adenocarcinoma histology. This unique risk group is likely to have distinct molecular drivers, especially EGFR, ALK, and ROS1 mutations.In National Taiwan Cancer Registry data, more than half (53%) of all newly diagnosed lung cancer patients and 93% of female patients are lifelong never-smokers. This scenario is common in East Asia. It is essential to develop a different strategy for screening lung cancer patients with other high-risk profiles. Several risk factors have been identified in never-smoking lung cancer and one of the most important factor is a lung cancer family history (LCFH) in a first-degree relative. Other high-risk occupational or environmental factors include air-pollution exposed occupations (such as traffic policeman and street cleaners) for at least 10 years, cooking index ≥ 110, defined as 2/7 \* days cooking by pan frying, stir frying, or deep frying in one week \* years cooking, cooking without using ventilation, passive smoke exposure, and history of pulmonary tuberculosis or chronic obstructive pulmonary disorders.

As described above, three high risk groups are interested in this study, the previous heavy smokers (group 1); those who has family history (group 2) and those who have high risk occupation or environment factors (group 3). From the published researches, we assume the detection rate to be 1.1% for group 1 based on NLST results16, 2.6% for group 2 (395 out of 12,011 subjects in TALENT), and we assume the detection Group 3 to be 1% after consulting board-certified senior specialists in this field.

This is a prospective, multi-center, single arm study in Taiwan of subjects who are eligible to receive LDCT screening based on recommendation of Health Promotion Administration of Taiwan.

The primary objective of TRIO part A is the LDCT screening acceptance rate of high lung cancer risk subjects.

The primary objective of TRIO part B is the exact lung cancer detection rates in these three groups.

Other secondary objectives are also included.

blood samples, urine samples, lung tissue samples.

Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration

Taiwan Real-world Low-dose Computed Tomography Screening behavIor and Outcome Research for High Risk Subjects Based on Health Promotion Administration-part A: Questionnaire Survey -Part B: LDCT Screening Outcome and Management

1. Eligible participants must meet the inclusion and exclusion criteria of this study
2. Only the one who completes the detailed questionnaire survey is counted.

Cytological or Pathological proof of lung cancer to investigate the overall lung cancer detection rate

AstraZeneca

Gee-Chen Chang

Chung Shan Medical University

Symptoms and General Pathology

Behaviors and Mental Disorders

Death

Quality of Life

In the intervention arm, Patients and their family caregivers have access to a coping and communication support practitioner (CCSP) (see intervention description) in addition to receiving the usual care in the site.

In the control arm, Patients are receiving the usual care in the site.

Trained clinical nurse specialists with masters� degrees in mental health will serve as CCS practitioners and they will be available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise.

The CCS intervention is tailored to individual preferences over time, and designed to accommodate different age groups, especially older adults and their families.

coping and communication support (CCS) intervention

Julia Rose, PhD MA

The diagnosis of advanced, incurable cancer at different stages of the adult life span holds a variety of meanings for family members who often must play critical roles in patient care and decision-making. Family caregivers are greatly affected by the diagnosis and treatment of late-stage cancer in a loved one and may find it difficult to meet the demands of taking care of their loved one through end-of-life care and taking care of their own well-being. This grant provides funding to examine processes and outcomes of the intervention for family caregivers of advanced cancer patients.

We are testing a coping and communication support (CCS) intervention for advanced stage cancer patients and their family caregivers over the period when goals of care may shift, i.e. beginning shortly after diagnosis. This randomized clinical trial is being conducted in two urban tertiary cancer clinics that reach patients and families in low income and diverse underserved populations: the Louis Stokes Cleveland VAMC and MetroHealth Medical Center. Recruitment and randomization are based on patient's diagnosis and age. The patient had to have been diagnosed with a stage IV cancer within a year of enrollment and they must fall into one of two age groups: middle-aged (ages 40-60); or older (61 and older). Patients are stratified by age group and then randomized to usual care or CCS intervention. Family care-givers are randomized along with the patient. Trained clinical nurse specialists with advanced training in mental health serve as CCS practitioners. They are available to patients and family caregivers on a 24/7 basis to assist with coping and communication challenges as they may arise. The primary goal of this project is to examine main effects of the intervention and patient age group interaction effects of the CCS intervention on perspectives and well-being of family caregivers during advanced cancer care and in bereavement.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Taiwan Real-world LDCT Screening Behavior and Outcome Research for High Risk Subjects Based on Health Promotion Administration	NCT05557487	Lung Cancer High-Risk Cance... Smoking Pollution; Expo... Family Relation...	Low dose comput...	20 Years - 80 Years	Chung Shan Medical University
Aging and Family Outcomes in Supportive Care of Advanced Cancer Patients	NCT00106067	Aging Neoplasms	coping and comm...	18 Years -	VA Office of Research and Development

Spots Global Cancer Trial Database for family relations