Participants receive education about both cancer and CVD risk factors and their relationship to dietary and physical activity health behaviors.

Participants receive education about CVD risk factors and their relationship to dietary and physical activity health behaviors.

Integrated group receives education about risk factors for both cancer and CVD whereas the non-integrated group receives information about CVD only to assess differences in health behavior outcomes.

Integrated vs Non-integrated Risk Education

Chanita H Halbert, PhD

The investigators will evaluate the effects of an integrated risk counseling program on behavioral and psychological outcomes in African American men and women in a randomized trial that is implemented and evaluated collaboratively through the West Philadelphia Consortium to Address Disparities. The specific aims of this research are as follows:

1. To evaluate the effects of integrated versus disease specific counseling on risk exposure behaviors. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater intake of fruits and vegetables and increased rates of physical activity.
2. To evaluate effects of integrated versus disease specific counseling on psychological outcomes. The investigators predict that compared to individuals who receive disease specific counseling, those who receive integrated counseling will report greater risk comprehension related to cancer and cardiovascular disease and will be more motivated to make behavioral changes.
3. To identify the mechanisms through which integrated risk counseling leads to behavioral change. The investigators predict that changes in risk exposure behaviors (e.g., diet and physical activity) will be mediated by increased risk comprehension and self-efficacy for diet and physical activity.

West Philadelphia Consortium Randomized Control Trial

West Philadelphia Consortium to Address Disparities

University of Pennsylvania

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Giulia Veronesi, MD

Federica Cioffi

This project aims to implement a health prevention program for smokers or former smokers including early detection of lung cancer, cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD). The clinical activity is completed by a pre-clinical evaluation of molecular bio-markers of early diagnosis of these diseases, with the aim of strengthening the sensitivity and specificity of the screening program.

The project also includes a cost-effectiveness assessment to validate the feasibility of the program.

Since lung cancer, CVD and COPD are among the deadliest smoking-related pathologies, the program includes actions aimed at raising awareness among primary care physicians, increasing the smoking cessation rate of participating subjects to improve quality of life.

Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention

Subjects with increased risk for lung cancer, selected through an epidemiological questionnaire, sign the informed consent and their blood is collected. They then undergo LDCT and an interview at the anti-smoking center. CTs presenting with at least one non-calcified nodule are managed according to dedicated diagnostic algorithm. Nodules indicative of lung cancer will be studied with preoperative diagnosis, with surgical resection preferably performed with a minimally invasive approach. Multimodality treatment is indicated in advanced stage of disease. Subjects with normal findings are scheduled for annuals CT scan for two additional years. Cardiovascular risk will be assessed with the use of the atherosclerotic cardiovascular disease (ASCVD) score, recommended by the American College of Cardiology/American Heart Association, integrated with Reynold risk score and CAC score. The CAC score, calculated on LDCT, is used to quantify the presence of calcium through the coronary system.

Ten ml of blood is collected before LDCT, for plasma and white blood cells. For lung cancer patients, blood is collected before treatment, at 1-6-12 months after treatment, to analyse markers for minimal residual disease or early recurrence.

We will perform:

* CTC identification and genomic analysis. Patients are considered CTCs positive based on cytopathology of the isolated cells and detection of characteristic malignant features.
* Evaluation of Serum of PTX3, measured with an original sandwich enzyme-linked immunosorbent assay (ELISA)
* Circulating microRNA profiling. A custom panel of 6 specific microRNAs identified in a previous study on Karolinska cohort and correlating with increase/reduction risk of CVD Mayor adverse cardiovascular events MACE will be tested in 2000 patients.
* IL-2, IL-8, CRP, IL-5 and Eosinophils analyses. Interleukin-2 and-8, C-reactive protein, interleukiine-5 and eosinophils concentrations in blood are measured with ELISA kits.

Cost-benefit analysis of the prevention program. Direct and indirect costs associated with diagnosis and treatment of smoking-related diseases will be compared to those of a control group with disease detected after the appearance of pulmonary symptoms. The incremental cost effectiveness ratio will be evaluated in terms of QUALYS (quality of life adjusted years saved).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
West Philadelphia Consortium Randomized Control Trial	NCT01299883	Cancer Cardiovascular ...	Integrated vs N...	18 Years - 75 Years	University of Pennsylvania
West Philadelphia Consortium Randomized Control Trial	NCT01299883	Cancer Cardiovascular ...	Integrated vs N...	18 Years - 75 Years	University of Pennsylvania
Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention	NCT04315766	Lung Cancer Cardiovascular ... Chronic Obstruc...		55 Years -	Istituto Clinico Humanitas

Spots Global Cancer Trial Database for cardiovascular disease (cvd)