Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

A subject can voluntarily discontinue active screening with LDCTs after the baseline LDCT is completed but will remain in study follow-up with follow-up calls in 12-month intervals for up to 10 years since initial consent

Low dose CT

Um Sang-Won, PhD

This is a single-arm prospective pilot study in a single institution. The target accrual is 200 participants of Korean, female sex, never smoker status, and family history of lung cancer. The study will aim to enroll 200 participants in two years.

Interested individuals will contact a research coordinator who will help to assess for study eligibility. Individuals who are eligible and able to sign informed consent will then proceed to have a LDCT screening exam with a result reported by a radiologist approved to read lung cancer screening scans. Results of this screening test will be discussed with the subject and further recommendations will be given. Negative results will proceed to have repeat LDCT exams for two additional years. Positive results will be recommended to have further diagnostic work-up, and possible treatment. Those with positive findings may be recommended to repeat a LDCT at varied intervals (e.g. at 3 months, at 6 months, etc.) per Lung-RADS recommendations which can be conducted as a research LDCT or as standard-of-care.

In addition, blood draw collection for a plasma-based assay will be collected at baseline, first year and second year for all patients along with the repeated LDCT scans.

A medical history questionnaire containing questions regarding ethnicity, family history of lung cancer, environmental exposures including secondhand smoke exposure, and a residential district to estimate the exposure of PM2.5 or PM10 will be given to the patient at the initial visit after informed consent has been obtained (Appendix A). Questionnaire can be collected within 1 month from the baseline consent.

A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females

A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females Who Are Never Smoker With a Family History of Lung Cancer

Whether lung cancer is found in each screening test conducted for the first (baseline) and first and second years

number of lung cancer diagnosed, number of stage I, rate of surgery, rate of false positive

Sang-Won Um

professor

Proactive Automatized Lifestyle intervention Frequency: 3 times (month 0, 1, 3) Dosage: Individually tailored feedback corresponding to about 1-6 pages Duration: 3 months

Multi-behavioral; including individually-tailored, theory-based, repetitive, ipsative and normative feedback.

Proactive Automatized Lifestyle intervention

Jennis Freyer-Adam, Prof. Dr.

Ulrich John, Prof. Dr.

Background: The co-occurrence of health risk behaviors (HRBs), namely of tobacco smoking, insufficient physical activity, unhealthy diet and at-risk alcohol use, more than doubles the risk of cancer, other chronic diseases and mortality; and applies to more than half of adult general populations. However, preventive measures that target all four HRBs and that reach the majority of the target populations and particularly those persons most in need and hard to reach (e.g. with low socio-economic status), are scarce. Electronic interventions may help to efficiently address multiple HRBs in whole populations, such as health care patients. The aim is to investigate the acceptance of a proactive and brief electronic multiple behavior change intervention among general hospital patients with regards to reach, retention, equity in reach and retention, satisfaction and subsequent trajectories of behavior change motivation, HRBs and health.

Methods: A pre-post-intervention study with four time points will be conducted at a general hospital in Germany. Patients admitted to participating medical departments (internal medicine, general surgery, trauma surgery, ear-nose-throat medicine) and aged 18-64 years will be systematically approached and invited to participate, irrespective of reason for admission and HRB profile. Based on HRB profile and on psychological behavior change theory, participants (n=175) will receive individualized computer-generated feedback concerning all four HRBs and motivation-enhancing feedback for up to two HRBs; directly on the ward and 1 and 3 months later. Intervention reach and retention will be determined by the proportion of participants among eligible patients and participants, respectively. Equity in reach and retention will be measured with regards to school education and other socio-demographics. To investigate satisfaction with the intervention and trajectories of motivational measures, HRBs and health measures, a 6-month follow-up will be conducted. Descriptive statistics, multivariate regressions and latent growth modelling will be applied.

Discussion: This study will be the first to investigate the acceptance of a proactive, electronic and brief multiple behavior change intervention among general hospital patients. If reach is high and efficacy established by a randomized controlled trial, the intervention has potential for public health impact in terms of primary and secondary prevention of diseases.

By nature, the participants, investigators and outcomes assessors of the single arm study are informed that an intervention is being (or has been) delivered.

Proactive Automatized Lifestyle Intervention

Proactive Automatized Lifestyle Intervention for Cancer Prevention

IPD that underlie results in a publication may be shared

Self-reported cardio-vascular disease, chronic respiratory disease, cancer disease, diabetes

Self-reported consultation of general practitioners past 6 months (number)

Self-reported consultation of medical specialists past 6 months (number)

Self-reported consultation of physiotherapists past 6 months (yes/no)

Self-reported consultation of psychologist/ psychotherapist/ psychiatrist past 6 months (yes/no)

Self-reported inpatient hospital care past 6 months (number of nights)

Self-reported outpatient hospital care past 6 months (number of admissions)

Proportion of participants among all eligible patients

Proportion of participants who continue participation 1 month after hospitalization

Proportion of participants who continue participation 3 months after hospitalization

Modified and adapted 29-item Multi-Dimensional Measure of Satisfaction with Behavioral Interventions; assessing process (intervention characteristic ratings, dose and format ratings, usage, overall intervention rating) and outcome (discomfort, attribution of outcomes to treatment)

European Health Interview Survey-Physical Activity Questionnaire, three additional items

Self-reported number of servings of vegetable and fruit per day; Self-reported intake of fat (gram, kilojoule, kilocalories), fiber (gram), salt (gram) and sugar (gram) per day measured by a 16 item diet screener on the number of servings of vegetable, fruit, other food rich in fiber, sweets, added sugar, sweetened drinks, cheese, convenience food, salted snacks, eggs, fatty fish, red meat, processed meat, butter/ oil, milk and bread per day/ week

Alcohol Use Disorder Identification Test - Consumption; alcohol use in past month

Self-reported number of cigarettes per day; smoking status

Behavioral health risk factors are determined when recommendations (WHO, World Cancer Research Fund, German Center of Addiction Issues) are not met; with the total sum score ranging between 0 and 4 behavioral health risk factors (insufficient physical activity, unhealthy diet, at-risk alcohol use, tobacco smoking)

Obtained from self-reported body weight and height

1 item on self-reported health ranging between poor (0) and excellent (4)

5-item Mental Health Inventory; Higher scores indicate better mental health

Number of self-reported sick days past 6 months

Behavior-specific staging algorithms based on the transtheoretical model of intentional behavior change (TTM)

Behavior-specific decisional balance questionnaires based on the TTM; higher scores indicate more pros and cons of physical activity / vegetable and fruit intake / alcohol use / tobacco smoking

Behavior-specific self-efficacy questionnaires based on the TTM; higher scores indicate higher self-efficacy to be physically active / to eat vegetable and fruit / to adhere to alcohol use limits / to refrain from tobacco smoking

Behavior-specific processes of change questionnaires based on the TTM; higher scores indicate higher process use in terms of increasing physical activity / eating more vegetable and fruit a day / reducing (or quitting) alcohol use / reducing (or quitting) tobacco smoking

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females	NCT06181929	Health Risk Beh...	Low dose CT	45 Years - 74 Years	Samsung Medical Center
Proactive Automatized Lifestyle Intervention	NCT05365269	Health Risk Beh...	Proactive Autom...	18 Years - 64 Years	University Medicine Greifswald
Proactive Automatized Lifestyle Intervention	NCT05365269	Health Risk Beh...	Proactive Autom...	18 Years - 64 Years	University Medicine Greifswald
Proactive Automatized Lifestyle Intervention	NCT05365269	Health Risk Beh...	Proactive Autom...	18 Years - 64 Years	University Medicine Greifswald
A Prospective Study for the Early Diagnosis of Lung Cancer in Korean Females	NCT06181929	Health Risk Beh...	Low dose CT	45 Years - 74 Years	Samsung Medical Center

Spots Global Cancer Trial Database for health risk behaviors