Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Rare Diseases

Lung Neoplasms

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Calcinosis

Undiagnosed Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Respiratory Tract Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Chronic Graft Versus Host Disease

Lipid Regulating Agents

All Drugs and Chemicals

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy.

Coronary artery Calcification (CAC) score obtained from lung cancer screening CT Scan images

Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy.

CAC score obtained from lung cancer screening CT Scan images

Patients with untreated COPD or not on first line guideline recommended therapy.

Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.

Educational material and treatment recommendations for patients, general practitioners and pharmacists

Nicole Ezer, MD

Nicole Ezer, MD MPH

Charlotte Besson, PHD

Emily McDonald, MD MSc

Does an educational intervention for untreated COPD and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months

Quebec Lung Cancer Screening PLUS Trial

Quebec Lung Cancer Screening PLUS Trial - a Randomized Controlled Trial of an Educational Intervention for Untreated Chronic Obstructive Pulmonary Disease (COPD) and/or Cardiovascular Disease (CVD) Identified During Lung Cancer Screening

Among patients with moderate to severe coronary artery calcifications (CAC) not on a statin at baseline, any statin prescribed for primary prevention at least once in the 1 year following the first low dose CT scan.

(aim 1)

Among patients who have untreated or inappropriately treated COPD at baseline, any long acting muscarinic antagonist inhaler prescribed at least once in the 1 year following the first low dose CT scan (aim 2)

Reflects patient adherence. Days of drug supply over 1 year with cholesterol lowering medication in the previous 1 year from pharmacy dispensation records.

Reflects patient adherence. Days of drug supply over 1 year with guideline concordant inhaler therapy for COPD in the previous 1 year from pharmacy dispensation records.

COPD Assessment Test is a validated patient-reported outcome. It measures 8 symptoms of COPD on a 0-5 point scale at baseline, 6 and 12 months post intervention

SF-36 questionnaire will be filled at baseline and 12 months post intervention

COMRADE is a 20-item self-reported measure for use in primary care to assess risk communication and confidence in treatment decision making. It assesses patient satisfaction with information provided about risks/benefits of treatment, perception of participation in treatment decisions, and satisfaction with that decision.

COMRADE questionnaire will be sent to patients after their first meeting with their general practitioner up to 3 months after intervention.

Number of unplanned clinic visits, hospitalizations for respiratory or cardiac disease, consultations with specialists (cardiology and respirology), invasive/non-invasive cardiac or respiratory investigations

Work productivity and activity impairment (WPAI) questionnaire

Health literacy will be assessed at study entry using the Brief Health Literacy Screen.

Nicole Ezer, MD, FRCPC, MPH

Assistant professor of medicine

Heart and Blood Diseases

Substance Related Disorders

Wounds and Injuries

Nervous System Diseases

Acute Coronary Syndrome

Carcinoma

Syndrome

Pain

Cardiotoxicity

Chest Pain

Coronary Artery Disease

Ischemia

Myocardial Ischemia

Heart Diseases

Vascular Diseases

Neurologic Manifestations

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Acute Graft Versus Host Disease

Antineoplastic Agents

Fluorouracil

a sub-acute cardiologic assessment and aggressive management of risk factors before oncologic treatment

Aggressive ischemic risk factor management

Cardiologic assessment

Mads D Lyhne, MD, PhD

Vibeke B Hansen, MD, PhD

Lars H Jensen, MD, PhD

This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard oncological treatment or a cardiological assessment prior to the 5-FU treatment. The investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic patients will reduce the number of hospitalisations and investigations for acute coronary syndrome during and after 5-FU treatment and that patients with high coronary artery calcium scores are more likely to experience chest pain during the treatment with 5-FU.

Prevention of Chest Pain in Chemo-treated Cancer Patients

Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil

Composite endpoint of the incidence of overall mortality, chest pain requiring hospital admittance, the incidence of coronary angiography intervention and acute coronary syndrome

Region of Southern Denmark

Vejle Hospital

Coronary Disease

Arteriosclerosis

Arterial Occlusive Diseases

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination.

Patients in the control group will not receive any letter in the mail with their coronary calcium score and educational materials.

Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination which will include the following:

1. Their calcium score, brief educational content explaining what the calcium score means and how the presence of coronary calcifications is associated with an increased risk of a cardiac event.
2. Guidance on what actions could be taken to decrease the risk of a heart event, including blood cholesterol management, smoking cessation, weight loss, dieting, exercise, and blood pressure control.
3. For patients with CAC\>0, the letter will encourage the patient to pursue a shared decision- making discussion with his/her primary care physician or cardiologist regarding risk reduction strategies.
4. Links to American Heart Association (AHA) and phone number for study research coordinator.

Educational Letter Post CT Examination

Etta Pisano

Prachi Agarwal, MD

Karen Ordovas, MD

This multicenter clustered randomized prospective study will be managed by the American College of Radiology Center for Research and Innovation (ACR CRI). The research team aims to test the efficacy of a patient-centered educational intervention based on coronary artery calcification (CAC) information in cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.

Objectives:

The overall goal of the proposed study is to improve cardiovascular health of smokers and previous smokers, as CAD is the most common cause of death in this population. Patients enrolled in lung cancer screening programs compose a highly suitable cohort of heavy smokers and previous smokers with 55-80 years of age for testing interventions that could improve the cardiovascular health of the population

The objective is to use coronary artery calcification burden, derived from computed tomography studies obtained for lung cancer screening purposes, to motivate patients into improving their health habits. The specific goal of this study is to test the efficacy of a patient-centered educational intervention based on CAC information in appropriate statin use and cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.

Recruitment:

Patients will be sent a mail or email research packet containing the invitation to join the study, the consent form and the baseline survey. Alternatively, patients could receive a phone call regarding information about the study

Consenting:

Following screening for eligibility, IRB-approved, HIPAA-compliant informed consent will be obtained by the Research Coordinators medical at the two participating institutions Patient registration can occur only after evaluation for eligibility is complete, eligibility criteria have been met, and the study site is approved by the ACR. Participants must have signed and dated all applicable informed consents and authorization forms.

Randomization:

Investigators will randomly select (coin flipping) first month as intervention yes/no and then alternate monthly until the end of the enrollment period. Patients randomized to the CAC-based educational intervention will receive an educational letter within 8 weeks of CT examination.

Baseline Questionnaire:

After consent form is signed, patients will have the option to either complete research questionnaire independently or with the help of the research coordinator over a virtual visit Patient will then mail or email the survey back to the research coordinator.

Patient's demographics and socioeconomic status will be inquired including age, gender, gender-identity and race/ethnicity, level of education, range of income, and health insurance status. The baseline cardiovascular health questionnaire will include data on lifestyle and eating habits, smoking status, known cardiovascular diseases, previous cardiovascular interventions, known cardiovascular risk factors such as obesity, hypercholesterolemia, hypertension, family history of heart disease, current use of statins or aspirin, current recommendation to use Statins or aspirin, willingness to pursue lifestyle modifications to reduce cardiovascular risk, and co-morbidities.

An exercise activity level questionnaire (IPAQ-7), a standardized anxiety questionnaire (GAD-7) and a patient activation questionnaire (PAM short) will also be applied.

In addition to data obtained in the baseline questionnaire, medical records, when available, will be reviewed for confirmation of height, weight, and blood pressure at the time of lung cancer screening appointment.

6-Month Follow Up Questionnaire: Approximately 6 months after consent, patients will receive the follow up mail or email research packet containing the follow up questionnaire. Alternatively, patients can receive a follow-up phone call to review the questionnaire. Questionnaire will address the main study outcomes including changes in lifestyle like exercise habit (IPAQ-7), smoking cessation, weight loss, initiation or dose change of Statin or aspirin, adherence to statin or aspirin prescription, level of anxiety (GAD-7), activation level for health self-care (PAM-short), number of cardiovascular imaging tests (echocardiography, catheterization, cardiac stress test, cardiac CT or cardiac MR) performed, and number of clinical visits motivated by the intervention or not.

Image Analysis for Coronary Artery Calcium Quantification:

All patients will have received a Low Dose CT of the chest for Lung cancer screening, as part of their clinical care. The LCS CT images will be analyzed by the site chest radiologist as per clinical care, and the report will include a qualitative statement on burden of coronary artery calcifications (none, mild, moderate, or severe), based on current guideline recommendations. In patients randomized to the intervention arm, quantification of calcium score using the Agatston score method will be performed by a member of the research team and reviewed by study site PI.

Impact of Patient-Centered Approach for Communicating Coronary Calcium on Cardiovascular Health

There is no plan to share individual patient data to other researchers.

Rate of statin use (how often patients are required to take statin medications) and adherence (how often patents comply with taking statin medications as prescribed) to prescription in patients with known hypercholesterolemia. This will be determined by patients' self-reported answers to questions during interviews and review of medical records. Both rate of statin use and patient compliance will be used to generate a single, overall assessment of how well patients are being treated for and managing their hypercholesteremia.

Changes in exercise level, surveyed using International Physical Activity Questionnaire (IPAQ-short) questionnaire. The IPAQ-short questionnaire is comprised of 7, self-reported, open-ended questions surrounding individuals' last 7-day recall of physical activity. The questionnaire estimates the total physical activity in Metabolic Equivalent of Task (METs)- min/week and time spent sitting. Scores vary depending on the person's activity level throughout the preceding 7 days, and there is not defined range for scores, as the questions are open ended (e.g. How many hours did you spend doing vigorous activities during the last 7days?).

Patients' self-reported smoking habits will be assessed via phone call or questionnaire at baseline and 6-month follow-up.

Patient reported blood pressure changes and initiation of anti-hypertensive therapy. Both systolic/diastolic blood pressure will be measured.

Patient anxiety, measured by changes in Generalize Anxiety Disorder-7 (GAD-7) anxiety questionnaire 6 months after intervention. The GAD-7 questionnaire is rated on a scale from 0-21, with higher scores indicating higher patient self-reported anxiety levels.

Clinical visits, cardiac imaging tests, and hospitalizations 6 months after the intervention, to be measured by medical record review (to be assessed by research coordinator at 6 month follow-up) and follow up phone survey (patient self-reporting). Number of visits, obtained from both the patient interview and patient medical records, for both invasive and noninvasive hospitalizations, will be combined to generate a single number, or complete total number of visits patients have experienced 6 months after intervention.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quebec Lung Cancer Screening PLUS Trial	NCT05444062	COPD Coronary Artery...	Educational mat...	55 Years - 74 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre
Prevention of Chest Pain in Chemo-treated Cancer Patients	NCT03486340	Solid Carcinoma 5-Fluorouracil ... Cardiotoxicity Chemotherapeuti... Acute Coronary ... Coronary Artery... Chest Pain	Cardiologic ass...	18 Years -	Vejle Hospital
Prevention of Chest Pain in Chemo-treated Cancer Patients	NCT03486340	Solid Carcinoma 5-Fluorouracil ... Cardiotoxicity Chemotherapeuti... Acute Coronary ... Coronary Artery... Chest Pain	Cardiologic ass...	18 Years -	Vejle Hospital
Impact of Patient-Centered Approach for Communicating Coronary Calcium on Cardiovascular Health	NCT06055972	Coronary Artery... Cardiovascular ... Smoking	Educational Let...	50 Years - 80 Years	American College of Radiology
Prevention of Chest Pain in Chemo-treated Cancer Patients	NCT03486340	Solid Carcinoma 5-Fluorouracil ... Cardiotoxicity Chemotherapeuti... Acute Coronary ... Coronary Artery... Chest Pain	Cardiologic ass...	18 Years -	Vejle Hospital
Quebec Lung Cancer Screening PLUS Trial	NCT05444062	COPD Coronary Artery...	Educational mat...	55 Years - 74 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for coronary artery calcification