# data[].attributes.title
BO 011 - UNA OPERATIONS AND TECHNICAL SUPPORT SERVICES (OTSS)

# data[].attributes.funder_divisions[]
National Center for Advancing Translational Sciences (NCATS)

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National COVID-19 Cohort Collaborative (N3C): The National COVID-19 Cohort Collaborative (N3C) sponsors the NIH COVID-19 Data Enclave, one of the largest data enclaves in the world supporting COVID-19 research. N3C is a partnership among the NCATS-supported Clinical and Translational Science Awards (CTSA) Program hubs, with overall stewardship by NCATS. The N3C program consists of thousands of researchers, requiring enterprise level information technology (IT) support as part of a virtual research organization (VRO). This contract is necessary to ensure that NCATS and N3C can continue to provide adequate support for a secure, collaborative, VRO. This contract allows for continued support of the VRO which supports all of the required information technology functions to support an environment of over 4,000 users, including cloud-based productivity tools, a service desk, commercial and open-source deployments of analytical tools for the community to use, and expansion of the data types available for analysis, such as imaging, viral variant genomic sequences, etc. The common need is to share a collaborative cloud environment capable of ingesting billions of data points and performing a variety of complex analyses against multimodal data types, ranging from pathology and radiology data, synthetic data, genomic information, electronic health records (EHRs) and a wide variety of others. All of this must be done while meeting the highest levels of security and privacy, given the sensitivity of some of the data types being collected and the importance of the work being done in the environment. This contract provides support for all of these enterprise IT efforts.

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SECURE PLATFORMS SUPPORT FOR THE N3C, NIDAP, AND ASPIRE

# data[].attributes.funder_divisions[]
National Center for Advancing Translational Sciences (NCATS)

# data[].attributes.abstract
National COVID-19 Cohort Collaborative (N3C): The National COVID-19 Cohort Collaborative (N3C) sponsors the NIH COVID-19 Data Enclave, one of the largest data enclaves in the world supporting COVID-19 research. N3C is a partnership among the NCATS-supported Clinical and Translational Science Awards (CTSA) Program hubs and the NIGMS-supported Institutional Development Award Networks for Clinical and Translational Research (IDeA-CTR), with overall stewardship by NCATS. The N3C Data Enclave is a secure platform storing harmonized clinical data provided by more than 60 contributing members. The Enclave hosts over 670 million clinical observations on over 6.8 million persons, including over 2.2 million COVID cases, amounting to more than 7.8 billion rows of data. To protect privacy, this data consists only of limited data sets, de-identified data sets, and synthetic data sets; there is no personally identifiable information kept in the Enclave. The Enclave resides in the NCATS Secure Scientific Platforms Environment. The Environment is a specialized cloud-based data aggregation and analytics enclave that can integrate, manage, secure, and analyze any kind of scientific data, and provide secure, controlled access to internal and external collaborators. Within the Environment, multiple NIH ICs, Federal agencies, and Federal task forces integrate, manage, secure, and analyze all types of scientific data using dedicated platforms, and, equally importantly, make that data available in specific and controlled collaborations with each other and with external collaborators.

# data[].attributes.title
NCI PATTERNS OF CARE STUDY FOR DIAGNOSIS YEAR 2021 (PROSTATE CANCER AND OVARIAN CANCER)

# data[].attributes.abstract
The National Cancer Institute (NCI) Patterns of Care (POC) studies describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. POC Studies are conducted periodically, typically annually, to satisfy a congressional directive (under Public Law 100-607, Sec. 413 (a)(2)(C) adopted on November 4, 1988) to the NCI to “assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessment in the biennial reports…”. To satisfy the directive and to update and enhance the utility of the POC Studies, a working group including representatives from the NCI’s Divisions of Cancer Control and Population Sciences and Cancer Treatment and Diagnosis and a representative from the American Cancer Society was developed to review knowledge gaps in cancer therapy dissemination and to develop priority areas for study. The group reached a consensus that a gap remains regarding factors associated with guideline use of biomarker tests and targeted therapy. Furthermore, the group determined there is limited information about the effects of the COVID-19 pandemic on cancer screening, diagnosis, treatment, and receipt of supportive/palliative care among individuals diagnosed with cancer. For feasibility reasons, the group also recommended that this POC Study be focused specifically on the patterns of care for patients newly diagnosed with prostate or ovarian cancer. This POC Study will also collect data on documentation of palliative care and patient financial impacts of the COVID-19 pandemic. Relevant information on cancer diagnosis, cancer recurrence and metastasis, patterns of care (e.g., utilization of biomarker testing, specific cancer treatments, supportive/palliative care), and patient financial stability shall be abstracted from medical records among patients aged 20 years of older who were diagnosed with prostate or ovarian cancer in 2021.

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NCI PATTERNS OF CARE STUDY FY24 - DIAGNOSIS YEAR 2021 (PROSTATE CANCER AND OVARIAN CANCER)

# data[].attributes.abstract
The National Cancer Institute (NCI) Patterns of Care (POC) studies describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. POC Studies are conducted periodically, typically annually, to satisfy a congressional directive (under Public Law 100-607, Sec. 413 (a)(2)(C) adopted on November 4, 1988) to the NCI to “assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessment in the biennial reports…”. To satisfy the directive and to update and enhance the utility of the POC Studies, a working group including representatives from the NCI’s Divisions of Cancer Control and Population Sciences and Cancer Treatment and Diagnosis and a representative from the American Cancer Society was developed to review knowledge gaps in cancer therapy dissemination and to develop priority areas for study. The group reached a consensus that a gap remains regarding factors associated with guideline use of biomarker tests and targeted therapy. Furthermore, the group determined there is limited information about the effects of the COVID-19 pandemic on cancer screening, diagnosis, treatment, and receipt of supportive/palliative care among individuals diagnosed with cancer. For feasibility reasons, the group also recommended that this POC Study be focused specifically on the patterns of care for patients newly diagnosed with prostate or ovarian cancer. This POC Study will also collect data on documentation of palliative care and patient financial impacts of the COVID-19 pandemic. Relevant information on cancer diagnosis, cancer recurrence and metastasis, patterns of care (e.g., utilization of biomarker testing, specific cancer treatments, supportive/palliative care), and patient financial stability shall be abstracted from medical records among patients aged 20 years or older who were diagnosed with prostate or ovarian cancer in 2021.

# data[].attributes.title
NCI PATTERNS OF CARE STUDY- DIAGNOSIS YEAR 2021 (PROSTATE CANCER AND OVARIAN CANCER)

# data[].attributes.abstract
The National Cancer Institute (NCI) Patterns of Care (POC) studies describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. POC Studies are conducted periodically, typically annually, to satisfy a congressional directive (under Public Law 100-607, Sec. 413 (a)(2)(C) adopted on November 4, 1988) to the NCI to “assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessment in the biennial reports…”. To satisfy the directive and to update and enhance the utility of the POC Studies, a working group including representatives from the NCI’s Divisions of Cancer Control and Population Sciences and Cancer Treatment and Diagnosis and a representative from the American Cancer Society was developed to review knowledge gaps in cancer therapy dissemination and to develop priority areas for study. The group reached a consensus that a gap remains regarding factors associated with guideline use of biomarker tests and targeted therapy. Furthermore, the group determined there is limited information about the effects of the COVID-19 pandemic on cancer screening, diagnosis, treatment, and receipt of supportive/palliative care among individuals diagnosed with cancer. For feasibility reasons, the group also recommended that this POC Study be focused specifically on the patterns of care for patients newly diagnosed with prostate or ovarian cancer. This POC Study will also collect data on documentation of palliative care and patient financial impacts of the COVID-19 pandemic. Relevant information on cancer diagnosis, cancer recurrence and metastasis, patterns of care (e.g., utilization of biomarker testing, specific cancer treatments, supportive/palliative care), and patient financial stability shall be abstracted from medical records among patients aged 20 years or older who were diagnosed with prostate or ovarian cancer in 2021.

# data[].attributes.title
NCI PATTERNS OF CARE STUDY FY24 - DIAGNOSIS YEAR 2021 (PROSTATE CANCER AND OVARIAN CANCER)

# data[].attributes.abstract
The National Cancer Institute (NCI) Patterns of Care (POC) studies describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. POC Studies are conducted periodically, typically annually, to satisfy a congressional directive (under Public Law 100-607, Sec. 413 (a)(2)(C) adopted on November 4, 1988) to the NCI to “assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessment in the biennial reports…”. To satisfy the directive and to update and enhance the utility of the POC Studies, a working group including representatives from the NCI’s Divisions of Cancer Control and Population Sciences and Cancer Treatment and Diagnosis and a representative from the American Cancer Society was developed to review knowledge gaps in cancer therapy dissemination and to develop priority areas for study. The group reached a consensus that a gap remains regarding factors associated with guideline use of biomarker tests and targeted therapy. Furthermore, the group determined there is limited information about the effects of the COVID-19 pandemic on cancer screening, diagnosis, treatment, and receipt of supportive/palliative care among individuals diagnosed with cancer. For feasibility reasons, the group also recommended that this POC Study be focused specifically on the patterns of care for patients newly diagnosed with prostate or ovarian cancer. This POC Study will also collect data on documentation of palliative care and patient financial impacts of the COVID-19 pandemic. Relevant information on cancer diagnosis, cancer recurrence and metastasis, patterns of care (e.g., utilization of biomarker testing, specific cancer treatments, supportive/palliative care), and patient financial stability shall be abstracted from medical records among patients aged 20 years or older who were diagnosed with prostate or ovarian cancer in 2021.

# data[].attributes.funder_divisions[]
National Center for Advancing Translational Sciences (NCATS)

# data[].attributes.abstract
National COVID-19 Cohort Collaborative (N3C): The National COVID-19 Cohort Collaborative (N3C) sponsors the NIH COVID-19 Data Enclave, one of the largest data enclaves in the world supporting COVID-19 research. N3C is a partnership among the NCATS-supported Clinical and Translational Science Awards (CTSA) Program hubs and the NIGMS-supported Institutional Development Award Networks for Clinical and Translational Research (IDeA-CTR), with overall stewardship by NCATS. The N3C program consists of thousands of researchers, requiring enterprise level information technology (IT) support as part of a virtual research organization (VRO). This contract is necessary to ensure that NCATS and N3C can continue to provide adequate support for a secure, collaborative, VRO. This contract allows for continued support of the VRO which supports all of the required information technology functions to support an environment of over 4,000 users, including cloud-based productivity tools, a service desk, commercial and open-source deployments of analytical tools for the community to use, and expansion of the data types available for analysis, such as imaging, viral variant genomic sequences, etc. The common need is to share a collaborative cloud environment capable of ingesting billions of data points and performing a variety of complex analyses against multimodal data types, ranging from pathology and radiology data, synthetic data, genomic information, electronic health records (EHRs) and a wide variety of others. All of this must be done while meeting the highest levels of security and privacy, given the sensitivity of some of the data types being collected and the importance of the work being done in the environment. This contract provides support for all of these enterprise IT efforts.

# data[].attributes.title
NCI PATTERNS OF CARE STUDY - DIAGNOSIS YEAR 2021 (PROSTATE CANCER AND OVARIAN CANCER)

# data[].attributes.abstract
The National Cancer Institute (NCI) Patterns of Care (POC) studies describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. POC Studies are conducted periodically, typically annually, to satisfy a congressional directive (under Public Law 100-607, Sec. 413 (a)(2)(C) adopted on November 4, 1988) to the NCI to “assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessment in the biennial reports…”. To satisfy the directive and to update and enhance the utility of the POC Studies, a working group including representatives from the NCI’s Divisions of Cancer Control and Population Sciences and Cancer Treatment and Diagnosis and a representative from the American Cancer Society was developed to review knowledge gaps in cancer therapy dissemination and to develop priority areas for study. The group reached a consensus that a gap remains regarding factors associated with guideline use of biomarker tests and targeted therapy. Furthermore, the group determined there is limited information about the effects of the COVID-19 pandemic on cancer screening, diagnosis, treatment, and receipt of supportive/palliative care among individuals diagnosed with cancer. For feasibility reasons, the group also recommended that this POC Study be focused specifically on the patterns of care for patients newly diagnosed with prostate or ovarian cancer. This POC Study will also collect data on documentation of palliative care and patient financial impacts of the COVID-19 pandemic. Relevant information on cancer diagnosis, cancer recurrence and metastasis, patterns of care (e.g., utilization of biomarker testing, specific cancer treatments, supportive/palliative care), and patient financial stability shall be abstracted from medical records among patients aged 20 years or older who were diagnosed with prostate or ovarian cancer in 2021.

# data[].attributes.title
Integrated Cognitive Rehabilitation and Cognitive Behavioral Therapy Intervention for patients with Post-COVID-19 Cognitive Impairment and Depression

# data[].attributes.funder_divisions[]
National Institute of Mental Health (NIMH)

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Research: The post-acute sequelae of SARS-CoV-2 infection (PASC) continues to pose an unprecedented public health burden, and cognitive impairment (CI) and depression are among the most common symptoms, which profoundly impacts functioning and quality of life. The purpose of this study is to develop and pilot a novel intervention to treat post-COVID CI and depression in patients with PASC by integrating two evidence-based interventions, cognitive rehabilitation (CR) based on Goal Management Training (GMT) and cognitive behavior therapy (CBT), and adapting the intervention specifically for ethnoculturally diverse patients with PASC. The specific aims are to: 1) Develop a manualized intervention for diverse patients with post- COVID CI and depression by adapting and enhancing a GMT CR+CBT approach and 2) Determine the feasibility and preliminary efficacy of the intervention on diverse patients with post- COVID CI and depression. To accomplish these aims, we will employ a mixed methods, design. Qualitative findings from focus groups with patients with PASC will guide the development of the intervention, which will be iteratively refined through additional semi-structured individual interviews and evaluated for feasibility and preliminary impact in a pilot randomized controlled trial (RCT). Candidate: The primary objective of this application is to support Dr. Jacqueline Becker's career development into an independent investigator studying the bidirectional impact of cognitive and mental health on chronic illnesses. Dr. Becker's proposed training activities are: 1) qualitative methodology; 2) psychosocial intervention development; and 3) RCT design, implementation, and evaluation. To achieve these goals, she has assembled a multidisciplinary mentoring team. Dr. Wisnivesky, her primary mentor, is a health services researcher with expertise in PASC, health disparities research, biostatistics, and RCT design and implementation. Her co-mentors include Dr. Lin, a clinician-investigator with expertise in qualitative research and chronic disease self- management in diverse adults, Dr. Feldman, a psychologist and expert in behavioral medicine psychosocial interventions, Dr. Murrough, a world-renowned psychiatrist with expertise in clinical trials for depression, and Dr. Bagiella, an expert in biostatistics and RCT design and evaluation. Environment: The Icahn School of Medicine at Mount Sinai has a strong tradition of outstanding research and the Department of Medicine is ranked 12th nationwide in NIH funding. The Division of General Internal Medicine has a well-established research infrastructure with an exceptionally strong record of successful and well-funded, mentored and independent investigators.

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Understanding Circuit Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection

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National Institute of Mental Health (NIMH)

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Individuals with neuropsychiatric manifestations of post-acute sequelae of SARS-CoV-2 infection (neuro-PASC) report cognitive impairment, new or worsening anxiety and/or depression, altered sleep, autonomic dysfunction, headache, dizziness, post-exertional malaise, and/or neuropathy, among other symptoms. Currently, an estimated 10% of individuals who contract SARS-CoV-2 go onto develop PASC, which represents an enormous disability as well as clinical, social, and economic burden worldwide. Yet, there is a large gap in our understanding of how neuro-PASC alters the function of the brain leading to persistent symptoms and deficits. In response to RFA-NS-23-021, this proposal is aimed at merging two powerful lines of investigation here at Yale to provide a biological basis for the clinical symptoms observed. The first strength is the NeuroCOVID Clinic at Yale, which has seen over 600 patients with neuro-PASC. We then created The COVID Mind Study at Yale under the leadership of Dr. Spudich and have enrolled over 90 participants with neuro-PASC and 60 controls with no PASC. The clinic and study will serve as key sources of subject recruitment. The second strength is the robust and innovative neuroscience and neuroimaging group at Yale under the leadership of Dr. Constable. His group has leveraged the NIH interest in the human connectome and developed methods that link circuit-level (dys)function in the brain to cognitive profiles measured through standardized testing and clinical symptoms. This framework uses a powerful predictive modeling approach and machine learning strategies to localize circuit (dys)function and quantify the contributions of different networks to clinical symptoms and behavior. With both of these strengths, we are ideally positioned to investigate this critical public health issue. Our preliminary data from The COVID Mind Study demonstrates significant cognitive deficits in individuals with neuro-PASC, particularly in language, working memory, declarative memory, non-dominant motor function, and perception compared to COVID negative controls. They also demonstrate greater negative valence issues, including depression, rumination, apathy, anxiety, and perceived stress. We also demonstrated the neuro-PASC group had significantly lower cerebral blood flow in the left superior parietal lobule compared to PASC negative controls using MRI perfusion imaging. To date, there have been no comprehensive assessments of the impact of neuro-PASC on brain function. Using novel methodology developed for this project centered on predictive models for generating reliable associations, we will identify the circuit level brain changes, potential compensatory mechanisms in each cognitive domain, and understand the distinct role of mood alterations in neuro-PASC. We will generate targets for the development of future treatment strategies in neuro-PASC. Our overarching hypothesis is that there are distinct changes in the brain-behavior circuits in individuals with neuro- PASC that will provide key insight into the pathophysiology of this disorder and guide future treatments. The outcome of these studies will have a major impact in how such patients are perceived and managed.