Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Exemestane

Letrozole

Mitogens

Palbociclib

Anastrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Protein Kinase Inhibitors

Antineoplastic Agents, Hormonal

Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare

Adult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy

Palbociclib with an aromatase inhibitor therapy

Aromatase Inhibitor

Pfizer CT.gov Call Center

A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States

Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.

Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor (AI vs. AI Alone)

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Pfizer

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Heart and Blood Diseases

Rare Diseases

Diabetes Mellitus

Depressive Disorder

Mental Disorders

Alzheimer Disease

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Depressive Disorder, Major

Depression

Heart Failure

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Lung Diseases

Cerebrovascular Disorders

Psychotic Disorders

Heart Diseases

Dementia

Brain Diseases

Central Nervous System Diseases

Tauopathies

Neurodegenerative Diseases

Neurocognitive Disorders

Respiratory Tract Diseases

Ischemia

Arteriosclerosis

Arterial Occlusive Diseases

Vascular Diseases

Chronic Disease

Disease Attributes

Schizophrenia

Schizophrenia Spectrum and Other Psychotic Disorders

Familial Alzheimer Disease

Chronic Graft Versus Host Disease

Care coordination, consisting variously (depending on the demonstration site)--nurse telephonic counseling, nurse in-person home visits, home telemonitoring equipment, and physician education and feedback.

Usual care in Medicare fee-for-service from beneficiaries' physicians and other health care providers

Depending on the demonstration site, may consist of nurse telephonic counseling and monitoring, nurse in-person or home visits, home telemonitoring equipment, patient educational materials, patient group educations classes, physician education and feedback.

Care Coordination

Randall S. Brown, Ph.D.

Carol A. Magee, Ph.D.

This is a Congressionally mandated study. In the original study, 16 demonstration programs provided care coordination services to beneficiaries with chronic illness in Medicare's fee-for-service program. A five-year CMS-funded study tested whether the programs can improve patients' use of medical services, improve patients' outcomes and satisfaction with care, and reduce Medicare costs. The study also assessed physicians' satisfaction with the programs.

In 2008 Congress extended the project for two of the original programs--Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare beneficiaries and provide care coordination services into the spring of 2010.

Mathematica Policy Research, Inc. (MPR) evaluated 16 independent demonstration sites that provide coordinated care interventions to Medicare beneficiaries with chronic illnesses. The rationale for the demonstration is the lack of coordination among the multiple providers typically serving Medicare beneficiaries with chronic illnesses, as well as the adverse consequences of the lack of coordination for the beneficiaries and for Medicare costs. The demonstration sites, selected in early 2001, offered programs designed to improve both the care that patients receive and patients' knowledge of, and adherence with, recommended self-care and behavior. The study estimated the effects of each site on patients' well-being and satisfaction, in addition to the site's effects on the use and cost of Medicare covered services. This analysis relied on a patient survey conducted 6 to 12 months after enrollment, and on Medicare claims data and any data available from the demonstration sites that could enhance the study. The study included two rounds of physician surveys. In each site, eligible applicants were randomly assigned to treatment and control groups. An extensive process analysis was conducted to describe the interventions in detail, with the key goal being an assessment of those factors that account for program success and failure. The study included case studies of each site, program profiles, interim site-specific memos, two interim summary reports, two reports to Congress (based on the interim summary reports), and a final summary report. This original study enrolled 18,277 beneficiaries.

In 2008 Congress extended the study for 2 of the sites, Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania, and they will recruit beneficiaries and provide demonstration intervention services through the spring of 2010. Mathematica Policy Research will evaluate the results of this extended demonstration using Medicare claims data and qualitative site visits to the two programs.

Evaluation of Programs of Coordinated Care and Disease Management

Centers for Medicare and Medicaid Services

Mathematica Policy Research, Inc.

Blood and Lymph Conditions

Immune System Diseases

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Multiple Myeloma

Neoplasms, Plasma Cell

COVID-19

Lymphoma

Leukemia

Communicable Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Graft vs Host Disease

Syndrome

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

Homologous Wasting Disease

Participants in this group will complete the baseline study activities, as described above. Additionally, participants will be instructed to create a Cue Health account and download the Cue Health App. Using the app and the 10 Cue Health COVID-19 molecular tests that are provided (or Cue Health Flu+COVID molecular tests if available and FDA authorized), the participant will perform tests after exposure or if symptoms arise. Participants can also use the test for close contacts who are exposed to COVID-19 and/or have symptoms. If COVID-19 infection occurs, participants will have access to telemedicine to discuss further with a healthcare professional. When clinically indicated, medication for the treatment of COVID-19 (and/or Influenza in case of Cue Health Flu+COVID test availability) will be prescribed and delivered to the participants' delivery address. Participants can also seek care through other healthcare providers or not seek care, at their discretion.

Participants in the control group will complete the baseline study activities, as described above. If symptoms arise or COVID-19 infection occurs, participants will test and seek care as they normally would.

Participants will receive at home COVID-19 test for themselves and others in their household.

Access to Cue Health COVID-19 Remote testing and treatment for COVID-19

The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients and those who are 65 years and older. They will also analyze whether these efforts lower the cost of care compared to standard of care.

This study is a randomized control trial with 10,000 participants. Participation will last for a minimum of 3 months and maximum of 8 months, depending upon COVID-19 case rates. Half of participants will be randomized to the control group and continue their existing testing and healthcare practices. The remaining participants will be randomized into the intervention arm. Participants in the intervention will receive one Cue Cartridge Reader for the duration of the study and up to 10 Cue COVID Molecular tests per month for their own use and to share with others in their household. In the case that a Cue Flu+COVID Molecular Test is available through FDA EUA or other authorization, participants may be provided this multiplex test in lieu of the Cue COVID Molecular Test. All intervention participants will be asked to test themselves if they are exposed or when symptoms arise and share tests with members of their household who are exposed to COVID or symptoms arise. The primary outcome will be the number of hospitalizations. This study will also compare infection rates, ICU admissions, deaths, and cost of care between the control and intervention group. The hypothesis is that access to high sensitivity portable molecular testing and subsequent telemedicine and prescription delivery can significantly decrease hospitalization and thereby the cost of care.

Interested individuals will access the study via the MyDataHelps platform by web or app to complete the eligibility and informed consent process. Within the MyDataHelps experience, participants will complete study activities such as surveys and sharing of claims data. Participants who are randomized to the intervention group will have the option to use Cue Care should they test positive for COVID-19. Cue Care contracts licensed Healthcare providers to deliver telemedicine and treatment for COVID-19. In the case that the COVID Flu+COVID test is available, the intervention group will also have the option to use Cue Care should they test positive for Influenza.

To learn more and take the eligibility survey, visit https://ImmunoCARE.scripps.edu/

ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals

Investigators will compare the number of hospitalizations between the control and intervention arms.

Investigators will compare the cost of care for COVID-19 infections between the control and intervention arms.

Cue Health

Scripps Translational Science Institute

Program Director

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.	NCT06086340	Breast Cancer	Palbociclib Aromatase Inhib...	65 Years -	Pfizer
Evaluation of Programs of Coordinated Care and Disease Management	NCT00627029	Congestive Hear... Diabetes Coronary Artery... Chronic Obstruc... Cancer Cerebrovascular... Alzheimer's Dis... Psychotic Disor... Major Depressio...	Care Coordinati...	-	Mathematica Policy Research, Inc.
ImmunoCARE: Rapid, Accurate COVID Testing to Reduce Hospitalization of Immunocompromised Individuals	NCT05655546	Immunodeficienc... Immunosuppressi... HIV Infections Graft Versus Ho... Leukemia Lymphoma Cancer Multiple Myelom... Transplant Age-Related Imm...	Access to Cue H...	18 Years - 120 Years	Scripps Translational Science Institute
Evaluation of Programs of Coordinated Care and Disease Management	NCT00627029	Congestive Hear... Diabetes Coronary Artery... Chronic Obstruc... Cancer Cerebrovascular... Alzheimer's Dis... Psychotic Disor... Major Depressio...	Care Coordinati...	-	Mathematica Policy Research, Inc.
Evaluation of Programs of Coordinated Care and Disease Management	NCT00627029	Congestive Hear... Diabetes Coronary Artery... Chronic Obstruc... Cancer Cerebrovascular... Alzheimer's Dis... Psychotic Disor... Major Depressio...	Care Coordinati...	-	Mathematica Policy Research, Inc.
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.	NCT06086340	Breast Cancer	Palbociclib Aromatase Inhib...	65 Years -	Pfizer

Spots Global Cancer Trial Database for medicare

Every month we try and update this database with for medicare cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for medicare

Every month we try and update this database with for medicare cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for medicare cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.