DP21-003_Final - Amended NOFO_v3_01.28.2021.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Reducing Inequities in Cancer Outcomes through Community-Based Interventions on Social

Determinants of Health

RFA-DP-21-003

Application Due Date: 02/10/2021

Reducing Inequities in Cancer Outcomes through Community-Based Interventions on Social

Determinants of Health

RFA-DP-21-003

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Reducing Inequities in Cancer Outcomes through Community-Based Interventions on Social Determinants of Health Activity Code U01

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-DP-21-003

Assistance Listings (CFDA) Number(s) 93.068 Category of Funding Activity:

Health NOFO Purpose The purpose of this NOFO is to conduct evaluation research to build an evidence base of innovative, community-based interventions across multiple social determinants of health to reduce racial and ethnic disparities related to cancer outcomes. The purpose will be achieved through three (3) components.

Component A: Primary Cancer Prevention – evaluation of the implementation, impact, and causal mechanisms of an intervention’s effect to reduce racial or ethnic inequities in cancer risk at the population level.

Component B: Cancer Screening – evaluation of the implementation, impact, and causal mechanisms of an intervention’s effect to reduce racial or ethnic inequities in the receipt of appropriate screening services for breast, cervical, colorectal or lung cancer.

Component C: Health and Wellbeing of Cancer Survivors – evaluation of the implementation, impact, and causal mechanisms of an intervention’s effect to reduce racial or ethnic inequities in the health and wellbeing of cancer survivors.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-21-003, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/11/2021

Application Due Date: 02/10/2021

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/09/2021

Secondary Review: 05/12/2021

Estimated Start Date: 09/30/2021

Expiration Date: 02/11/2021 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 Apply Electronically

Executive Summary

Purpose. The purpose of this NOFO is to conduct evaluation research to build an evidence base of innovative, community-based interventions across multiple social determinants of health to reduce racial and ethnic disparities related to cancer outcomes.

For this NOFO, evaluation research is defined as the systematic application of public health research procedures for assessing the conceptualization, design, implementation, effectiveness and utility of public health interventions. Cancer prevention is defined as reduced population risk for cancer. The purpose will be achieved through three (3) components.

Component A: Primary Cancer Prevention – evaluation of the implementation, impact, and causal mechanisms of an intervention’s effect to reduce racial or ethnic inequities in cancer risk at the population level.

Component B: Cancer Screening – evaluation of the implementation, impact, and causal mechanisms of an intervention’s effect to reduce racial or ethnic inequities in the receipt of appropriate screening services for breast, cervical, colorectal or lung cancer.

Component C: Health and Wellbeing of Cancer Survivors – evaluation of the implementation, impact, and causal mechanisms of an intervention’s effect to reduce racial or ethnic inequities in the health and wellbeing of cancer survivors.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. The estimated total funding

(direct and indirect) for the five-year period of performance, September 30, 2021 to September 29, 2026, is $15,000,000 to fund three (3) awards, one in each of the three Components.

Budget and Period of Performance. The estimated total funding for the first budget period, 9/30/2021-9/29/2022, is $3,000,000 (direct and indirect). The estimated total funding for the entire period of performance, 9/30/2021-9/29/2026, is $15,000,000 (direct and indirect).

Component A: Primary Cancer Prevention Period of Performance: 5 years (09/30/2021 to 09/29/2026)

Estimated Funding Per Year: Up to $1,000,000 Component B: Cancer Screening Period of Performance: 5 years (09/30/2021 to 09/29/2026) Estimated Funding Per Year: Up to $1,000,000 Component C: Health and Wellbeing of Cancer Survivors Period of Performance: 5 years (09/30/2021 to 09/29/2026) Estimated Funding Per Year: Up to $1,000,000

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic minority groups as well as individuals with disabilities are always encouraged to apply through their organization.

Number of PDs/PIs. Applications may include more than one PI; however, the first PI listed on the application will be the “contact PI” for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

Number of Applications. Only one application per institution (normally identified by having a unique DUNS number) is allowed. Applicants may apply for one (1) Component of funding (Component A, or Component B, or Component C).

Application Type. New Special Date(s). None Application Materials. See Section IV.1 for application materials. Please note that

Form F is to be used when downloading the application package that is available at https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/research-forms-f .pdf

A link to this NOFO on Grants.gov is available at https://www.cdc.gov/chronicdisease /programs-impact/nofo/index.htm

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority This program is authorized under the Public Health Service Act, 42 U.S.C. § 241(a) and 247b

(k) (2).

1. Background and Purpose It has been said that a person’s zip code is more important than their genetic code for health.[1]

This statement reflects the large body of scientific evidence linking nonmedical factors, such as economic opportunities and systemic racism, with health.[2-7] Today, the COVID-19 pandemic has increased national attention on the many societal-level inequities that impact racial and ethnic minority groups and can shape opportunities over a lifetime.[2, 8] These factors, commonly referred to as social determinants of health, also explain long-standing disparities in cancer outcomes across different racial and ethnic groups.[9] Cancer-related health outcomes often follow similar geographical gradients as social determinants of health.[10] Residential segregation based on race has had consequences for race-based disparities in cancer and other health outcomes.[11, 12] Neighborhoods provide a set of social and environmental circumstances and resources that can be either healthful or harmful.

A review of 17 studies on residential segregation [13] found most studies reported racial segregation contributed to cancer disparities, including later stage at diagnosis, higher mortality rates, and lower survival rates, even after adjustment for socioeconomic status. In addition, under-resourced and racially segregated communities are more likely to have higher levels of environmental pollution,[14, 15] which could negatively impact cancer outcomes. Racial residential segregation is regarded as one of the fundamental causes of racial disparities in health.[16] To reduce disparities and improve population health, the socio-ecological framework highlights the interrelationships between aspects of the social and physical environments that operate at multiple levels to influence health.[17] Consistent with this framework, change can occur at individual, interpersonal, community, and structural levels to promote cancer prevention and significantly reduce health disparities. The structural social determinants, the focus of this NOFO, correspond to the bottom tiers of the Health Impact Pyramid, where action taken can have the greatest population impact [18, 19], see figure. Structural social determinants influence opportunities, resources, and living conditions at the individual level.[9, 20] Scholars have noted that race disparities affect all aspects of the social and physical environments through a system of race discrimination, and disparities in one aspect reinforce disparities in another.[12, 21]

Several authors have pointed to the inability of traditional studies of health disparities and program evaluation to inform and affect structural and policy change.[2, 9, 22-24] In 2008, the Commission on Social Determinants of Health of the World Health Organization issued a report with findings and recommendations for closing the gap in health equity within a generation.[4] The commission emphasized the need to improve the conditions of daily life and tackle inequities in the distribution of power, money, and resources. Among the many factors discussed by this commission, working conditions and the nature of work were identified as important to health. Work provides financial security and often health insurance, and paid leave, when available, can increase the uptake of cancer screening.[25] This report also emphasized the need for evidence on the effectiveness of action on social determinants to reduce health inequities.

A recent review article examined the implementation of interventions to address social determinants of health within the healthcare sector involving mostly people with low-incomes from specific racial or ethnic minority groups and cancer screening.[26] Many of the interventions addressed immediate social needs, such as transportation and childcare assistance to attend screening appointments and patient navigators, rather than the structural factors underlying those needs. In contrast, other authors have described efforts to engage community residents and leaders as equal partners in structural and systemic interventions, not just as the recipients of social services.[27, 28] An equity-based approach would involve those most impacted and aim for sustained community change and transformative change in power, equity, and justice.[28] In 2020, the American Society of Clinical Oncology (ASCO) issued a policy statement on cancer disparities and health equity.[29] Among its recommendations, ASCO called upon professional organizations to pursue community partnerships, multisector collaborations, and local capacity building to address societal conditions (structural barriers) that preserve and promote inequities.

Various interventions including policy change are being implemented in communities across the country to address social determinants of health, but their impact on health has rarely been evaluated or quantified.[30-32] The Community Preventive Services Task Force has reviewed evidence on intervention approaches for health equity.[33] However, the available evidence is limited on the impact of interventions to address social determinants of health related to cancer prevention, cancer screening, and the health and wellness of cancer survivors.[9] Moreover, some have argued that persistent racial and ethnic disparities in cancer and other health outcomes cannot be eliminated without addressing the fundamental causes for these disparities:

socioeconomic status and racism.[12, 16] A recent review of the complex relationship between various forms of racism and health called for more research on interventions to mitigate the impact of racism on health.[21] Purpose The purpose of this NOFO is to conduct evaluation research to build an evidence base of innovative, community-based, structural interventions across multiple social determinants of health to reduce racial and ethnic disparities in cancer outcomes. The purpose will be achieved through three (3) components.

Component A: Primary Cancer Prevention – evaluation of the implementation, impact, and causal mechanisms of an intervention’s effect to reduce racial or ethnic inequities in cancer risk at the population level.

Component B: Cancer Screening – evaluation of the implementation, impact, and causal mechanisms of an intervention’s effect to reduce racial or ethnic inequities in the receipt of appropriate screening services for breast, cervical, colorectal or lung cancer.

Component C: Health and Wellbeing of Cancer Survivors– evaluation of the implementation, impact, and causal mechanisms of an intervention’s effect to reduce racial or ethnic inequities in the health and wellbeing of cancer survivors.

Healthy People 2030 and other National Strategic Priorities This research NOFO supports Healthy People 2030 (https://health.gov/healthypeople) [34] objectives within multiple topic areas. This NOFO will support the cancer goal to reduce the number of new cancer cases, as well as illness, disability, and death caused by cancer. The specific cancer objectives supported under this topic include:

C-3 Increase the proportion of adults who receive a lung cancer screening based on the most recent guidelines C-5 Increase the proportion of females who receive a breast cancer screening based on the most recent guidelines C-7 Increase the proportion of adults who receive a colorectal cancer screening based on the most recent guidelines C-9 Increase the proportion of females who receive a cervical cancer screening based on the most recent guidelines C-RO1 Increase the mental and physical health-related quality of life for cancer survivors In addition, this NOFO supports the Healthy People 2030 focus on social determinants of health. Although Healthy People 2030 identifies discrimination as a key issue within the social determinants of health, no measurable objectives are included to address systemic racism, an aim of the NOFO. The objectives related to this NOFO that address additional social determinants of health include:

NWS-01 Reduce household food insecurity and hunger EH-06 Reduce the amount of toxic pollutants released into the environment PA-10 Increase the proportion of adults who walk or bike to get places SDOH-01 Reduce the proportion of people living in poverty SDOH-02 Increase employment in working-age people HC/HIT-R01 Increase the health literacy of the population The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) seeks to achieve health equity through multisectoral and multilevel collaboration on the social determinants of health.[35] This research NOFO will support NCCDPHP work in these priority areas:

Built environment: human-made surroundings where people live, learn, work, play, worship and age that influence overall community health and individual behaviors that drive health. A healthy built environment facilitates access to transportation and physical resources that enhance quality of life, minimizes exposure to environmental contaminants, and supports physical activity, safe recreation, a safe workplace, and other protective factors.

Community-clinical linkages: connections made among health care systems and services, public health agencies, and community-based organizations to improve population health. Effective community-clinical linkages improve cancer outcomes by increasing access to and utilization of preventive and chronic care services in local communities.

Social connectedness: the degree to which individuals or groups of individuals have a desired number, quality, and diversity of relationships that create a sense of belonging and being cared for, valued, and supported. A high degree of social connectedness can increase the likelihood of individuals engaging in positive health behaviors, ultimately improving health outcomes by moderating the negative health effects of adversities such as stress, trauma, adversity, anxiety, and depression. Social connectedness can create opportunities to access resources that might otherwise be unavailable. In addition, social connectedness can contribute to collective efficacy to change policy, programs, and social norms.

Public Health Impact This NOFO will generate evidence on interventions to reduce cancer-related disparities by race and ethnicity by implementing and evaluating community-based efforts to improve cancer outcomes through structural changes in social determinants of health. Rigorous evaluation research will advance our understanding of what works, for whom and why.[24] This research will fill important gaps in knowledge about 1) the implementation and potential for scaling of innovative interventions to reduce racial and ethnic disparities in cancer outcomes, 2) the resources required for implementation and scaling, and 3) the impact of novel community-based approaches to reduce health inequities and improve cancer-related outcomes in economically or socially disadvantaged populations. In addition, the evaluation research will contribute to an underlying theory of causation or reveal specific elements and strategies that contribute to intervention effectiveness.

Relevant Work None

2. Approach There are three separate components to this NOFO. Applicants may apply for one of the following components: Component A: Primary Cancer Prevention, Component B: Cancer Screening, or Component C: Health and Wellbeing of Cancer Survivors. The application should clearly indicate which Component is being applied for.

Applicants should propose rigorous evaluation research of an on-going intervention, expanded as needed, to generate evidence about cancer prevention and control strategies that involve structural/systemic changes in social determinants of health (see lower tiers of the impact pyramid in Section1.1 Background and Purpose), including systemic racism. The research is expected to go beyond measures of effectiveness to address theories of causation and issues of implementation and adaptation for well-defined racial or ethnic minority populations under specific community contexts.

Systemic racism describes the accumulation and incorporation of long-standing racialized practices into social and economic structures. Systemic racism is broadly used in this NOFO to capture the related concepts of structural racism and institutional racism.[36, 37] Interventions should be community-based and address 1) systemic racism; and 2) one or more of the following: the built environment; community-clinical linkages; and social connectedness.

For this NOFO, the following definitions apply:

1. Built environment is broadly defined to include physical structures, the advertising environment, the distribution of community institutions and services, and the workplace.

2. Community-clinical linkages are defined as connections made among health care systems and services, public health agencies, agencies from other sectors, and community-based organizations, as well as efforts to promote inclusion and diversity in the clinical setting, to improve population health.

3. Social connectedness is the degree to which an individual or group of individuals are socially close, interrelated, or share resources with each other [38], and it is related to social isolation.[39] Social connectedness applies broadly to include the related concept of social capital, networks of relationships within and across communities that are a source of shared group resources and benefits to individuals.[40] These networks can be strengthened to expand their power and influence and, therefore, contribute to the collective efficacy needed to change policies, programs, and social norms to improve health.[41,42]

Applicants are encouraged to be innovative and opportunistic. For example, novel interventions to address systemic inequities, when carefully investigated, could serve as a natural experiment to inform future public health practice. Multi-sector and multilevel interventions are encouraged. The NOFO is not intended to fund evaluations of interventions that involve only counseling and education (see top of the impact pyramid in Section 1.1 Background and Purpose), but multi-level interventions could include this element.

For all components, this evaluation research could involve nonrandomized studies with rigorous attention to comparability and bias (quasi-experimental research). Depending on the complexity of the intervention strategies to be evaluated, multiple and mixed methods could be employed, such as an examination of large data sets combined with case studies, and various types of evaluation analyses.

Applicants under each component are expected to identify and engage key community partners from relevant sectors and community residents from the racial or ethnic minority groups of focus to participate throughout the research process.

Objectives/Outcomes Component A: Primary Cancer Prevention – to conduct evaluation research on an innovative, community-based intervention to reduce cancer risk in one or more racial or ethnic minority populations who experience disproportionate exposure to cancer risk factors. This research will assess the implementation, impact, and causal mechanisms of the intervention’s effect to reduce cancer risk at the population level. Research in this component will build the evidence base for community-based interventions for reduced cancer incidence at the population-level (primary cancer prevention) among racial and ethnic minority populations.

1. Generate evidence regarding the effectiveness of a multi-factor community-based intervention focused on the built environment to reduce exposures to carcinogens or change cancer-related health behaviors to reduce cancer risk and/or social connectedness to increase the adoption of healthy behaviors and influence on policies, programs and social norms associated with lower cancer risk.

2. Generated evidence regarding the impact of addressing systemic racism on the effectiveness of the intervention focused on one or more racial and ethnic minority populations.

3. Inform the theory of causation underlying the different elements of the intervention.

4. Determine challenges in implementation and adaptation for one or more racial and ethnic minority groups in a specific setting and make recommendations for challenges to be addressed when repeating or scaling the intervention.

Recipient is expected to:

Select a promising, on-going intervention being implemented in a community that focuses on the built environment and/or social connectedness to reduce cancer risk among people from one or more racial or ethnic minority groups. The intervention should be informed by evidence that suggests the proposed approach, which could involve influencing policies, programs or social norms, could result in change in exposures to carcinogens or cancer-related health behaviors within the study period. The original purpose of the intervention need not be cancer prevention, provided the intended outcomes include reduced carcinogenic exposures or changes in behaviors that lead to reduced cancer risk. Interventions that address multiple or clusters of cancer risk factors (exposures and/or health behaviors) are encouraged. The intervention should not include: 1) chemo-preventive agents, drugs, or nutritional supplements of any kind; 2) vaccines; 3) prophylactic surgery; or 4) screening tests for cancer or pre-cancer conditions.

Use an evidence-based theoretical framework of causation to address systemic racism.

Expand the intervention population, as needed, to achieve a sufficiently large number of persons within a well-defined racial or ethnic minority group to allow findings to be generated for that group and yield stable estimates of intervention effects. A power analysis should be used to demonstrate that the proposed sample size is adequate to detect an intervention effect within the study period.

Anticipate, identify, and address problems in the implementation of the project in a transparent and timely manner.

Implement the multi-factor intervention, in collaboration with the entity implementing the original, on-going intervention and other community partners.

Conduct an evaluation research study to assess the effectiveness of the intervention overall and the core elements of the intervention. The primary outcomes should be measures of exposures or health behaviors.

Examine research questions within a framework of causal mechanisms of effectiveness.

Assess factors that serve as barriers or facilitators for successful implementation and adaptation.

Convene a Community Advisory Board that includes representatives of key community partners, government agencies, nonprofit organizations, and community residents that meets at least semi-annually to provide input and discuss progress and challenges. This board should include members who provide testing or other services to the population of focus related to the cancer risk factor, if the intervention relies on such services.

Analyze and disseminate study findings to public health audiences, community partners and residents, and other persons who may be interested in applying the study findings.

Prepare a final report that includes recommendations for translation, adaptation, scaling and sustaining the intervention focused on one or more racial or ethnic minority groups under specific community contexts.

Develop multiple manuscripts for publication in the scientific literature that present project findings and provide insights for adaptation and scaling.

Prepare a budget that includes travel costs for up to four people, including the PI, for annual meetings with CDC staff in the first Budget Period and in annual continuation plans and budgets. Funds may be used to cover reasonable, actual out-of-pockets costs incurred by Community Advisory Board members, as a result of attending scheduled meetings, and incentives for members who are not participating in meetings as part of their normal job duties.

Participate on monthly calls with CDC staff to discuss project progress, accomplishments and challenges.

Component B: Cancer Screening – to conduct evaluation research on an innovative, multi-sector intervention to reduce inequities in the receipt of appropriate screening and follow-up services for breast, cervical, colorectal or lung cancer (on-time initial screening, routine re-screening at recommended intervals, and appropriate follow-up after inconclusive/incomplete screening and abnormal test results) among one or more racial or ethnic populations who experience disparities in cancer screenings. This research will generate knowledge about the implementation, impact, and causal mechanisms of the intervention’s effect on the cancer screening outcomes. Research in this component will also build the evidence base for community-based, structural interventions on social determinants to decrease racial and ethnic disparities in the receipt of recommended cancer screening services.

1. Generate evidence regarding the effectiveness of a multi-factor community-based intervention focused on the built environment and/or community-clinical linkages to increase the receipt of appropriate cancer screening services.

2. Generate evidence regarding the impact of addressing systemic racism on the effectiveness of the intervention focused on one or more racial and ethnic minority populations.

3. Inform the theory of causation underlying the different elements of the intervention.

4. Determine challenges in implementation and adaptation for one or more racial and ethnic minority groups in a specific setting and make recommendations for challenges to be addressed when repeating or scaling the intervention.

Recipient is expected to:

Select a promising, on-going community-based intervention to improve the use of, and follow up for, one or more cancer screening tests as recommended in one or more racial or ethnic minority groups. The intervention should focus on one or more cancer screening tests with A or B recommendations from the U.S. Preventive Services Task Force: breast [43], colorectal [44], cervical [45], or lung cancer [46] and involve community-clinical linkages, and/or the built environment. An intervention that does not have cancer screening as its primary purpose may be studied, but the intervention should address one or more known barriers to cancer screening and be reasonably expected to improve cancer screening outcomes. Costs associated with the provision of medical services are not supported by this NOFO.

Use an evidence-based theoretical framework to address systemic racism.

Expand the intervention population, as needed, to achieve a sufficiently large number of persons within one or more racial or ethnic minority groups to allow findings to be generated for that group. A power analysis should be used to demonstrate that the proposed sample size is adequate to detect an intervention effect within the study period.

Anticipate, identify, and address problems in the implementation of the project in a transparent and timely manner.

Implement the multi-factor intervention, in collaboration with the entity implementing the original, on-going intervention and other community partners.

Conduct an evaluation research study to assess the effectiveness of the intervention overall and the core elements of the intervention. Consider all relevant outcomes across the screening continuum, including on-time initial screening, routine re-screening at recommended intervals, appropriate follow-up after inconclusive/incomplete screening, and follow up and treatment initiation after a positive test.

Examine research questions within a framework of causal mechanisms of effectiveness.

Convene a Community Advisory Board that includes representatives of key community partners (including health care providers who provide screening services to the community), government agencies, nonprofit organizations, and community residents that meets at least semi-annually to provide input and discuss progress and challenges.

Assess factors that serve as barriers and facilitators for successful implementation and adaptation.

Analyze and disseminate study findings to public health audiences, community partners and members, and other persons who may be interested in applying the study findings.

Prepare a final report that includes recommendations for translation, adaptation, scaling and sustaining the intervention focused on one or more racial or ethnic minority groups under specific community contexts.

Develop multiple manuscripts for publication in the scientific literature that present project findings and provide insights for adaptation and scaling.

Prepare a budget that includes travel costs for up to four people, including the PI, for annual meetings with CDC staff in the first Budget Period and in annual continuation plans and budgets. Funds may be used to cover reasonable, actual out-of-pockets costs incurred by Community Advisory Board members, as a result of attending scheduled meetings, and incentives for members who are not participating in meetings as part of their normal job duties.

Participate on monthly calls with CDC staff to discuss project progress, accomplishments and challenges.

Component C: Health and Wellbeing of Cancer Survivors – to conduct evaluation research to address barriers to health and well-being among adult cancer survivors from one or more racial or ethnic minority populations who experience disparities in mental or physical health after a cancer diagnosis. This research will generate knowledge about the implementation, impact, and causal mechanisms of the intervention’s effect on the health and wellbeing of cancer survivors. Research in this component will build the evidence base to support policies to assist cancer survivors from racial and ethnic minority groups to lead productive, healthy lives.

1. Generate evidence regarding the effectiveness of a multi-factor community-based intervention focused on the built environment and/or social connectedness and/or community-clinical linkages to improve the health and well-being of cancer survivors.

2. Generate evidence regarding the impact of addressing systemic racism on the effectiveness of the intervention focused on one or more racial and ethnic minority populations.

3. Inform the theory of causation underlying the different elements of the intervention.

4. Determine challenges in implementation and adaptation for one or more racial and ethnic minority groups in a specific setting, and make recommendations for challenges to be addressed when repeating or scaling the intervention.

Recipient is expected to:

Select a promising, on-going community-based intervention focused on community-clinical linkages and/or the built environment and/or social connectedness to address one or more known barriers to health and wellbeing among survivors of adult cancers from one or more racial or ethnic minority groups. Costs associated with the provision of medical services are not supported by this NOFO. The intervention outcomes of interest should include one or more of the following:

o reduced barriers to healthy behaviors;

o improved access to recommended preventive health services and behavioral counseling;

o reduced financial toxicity from recurring medical care costs;

o improved management, reduction or elimination of co-occurring chronic conditions such as diabetes and obesity;

o reduced barriers to returning to/remaining at work;

o improved quality of mental and physical health-related quality of life.

Use an evidence-based theoretical framework to address systemic racism.

Expand the intervention population, as needed, to generate evidence about the effectiveness of this intervention and generate stable estimates of outcome measures for cancer survivors from one or more racial or ethnic minority groups. A power analysis should be used to demonstrate that the proposed sample size is adequate to detect an intervention effect within the study period.

Implement the multi-factor intervention, in collaboration with the entity implementing the original, on-going intervention and other community partners.

Conduct an evaluation research study to assess the effectiveness of the intervention overall and the core elements of the intervention.

Examine research questions within a framework of causal mechanisms of effectiveness.

Convene a Community Advisory Board that include representatives of key community partners (including health care providers for cancer survivors in the community), government agencies, nonprofit organizations, and cancer survivors who are community residents that meets at least semi-annually to provide input and discuss progress and challenges.

Assess factors that serve as barriers or facilitators for the successful implementation and adaptation.

Analyze and disseminate study findings to public health audiences, community partners and members, and other persons who may be interested in applying the study findings.

Prepare a final report that includes recommendations for translation, adaptation, scaling and sustaining the intervention focused on one or more racial or ethnic minority groups under specific community contexts.

Develop multiple manuscripts for publication in the scientific literature that present project findings and provide insights for adaptation and scaling.

Prepare a budget that includes travel costs for up to four people, including the PI, for annual meetings with CDC staff in the first Budget Period and in annual continuation plans and budgets. Funds may be used to cover reasonable, actual out-of-pockets costs incurred by Community Advisory Board members, as a result of attending scheduled meetings, and incentives for members who are not participating in meetings as part of their normal job duties.

Participate on monthly calls with CDC staff to discuss project progress, accomplishments, and challenges.

Target Population Component A: Primary Cancer Prevention - The intervention should be designed to address the needs of people from one or more racial or ethnic minority groups who experience disparities in cancer incidence, exposure to carcinogens, or the prevalence of cancer-related health behaviors. The intervention population should be persons without a personal history of cancer and span multiple age groups, consistent with a lifespan approach to cancer prevention.

The age range of the population of focus should not be limited to children.

Component B: The intervention should be designed to address the needs of people from one or more racial or ethnic minority groups who experience disparities in cancer screening. The population of focus should be adults without a personal history of the cancer being screened for and not known to be at high risk of cancer. The age range of the intervention population should include the ages for which the selected cancer screening test is currently recommended by the U.S. Preventive Services Task Force (USPSTF).[43-46] Component C: Cancer Survivors - The intervention should be designed to address the needs of people from one or more racial or ethnic minority groups who experience disparities in health outcomes after a cancer diagnosis. The intervention population should be adults with a personal history of adult-onset cancer of any type (other than non-melanoma skin cancer) who have completed initial course of treatment with the intent to cure but may be continuing long-term hormonal treatment. Most of the intervention population should fall within the age range of 45- 84 years.

Collaboration/Partnerships Component A: Primary Cancer Prevention, Component B: Cancer Screening, and Component C: Health and Wellbeing of Cancer Survivors Investigators are expected to build on and expand collaborations and partnerships with researchers or agencies (e.g., community health clinics, cancer centers, community-based organizations, nonprofits, local governments, employers) that have interests in reducing cancer disparities, or that do not have established interests but nonetheless may influence key levers in reducing cancer disparities (such as influencing the availabilities of resources within communities). Such relationships could be useful for planning and/or implementation of their evaluation research plans. Applicants are expected to engage community residents with a commitment to reducing disparities, for instance, residents from the targeted population, in their research process (including planning and implementation).

Evaluation/Performance Measurement Component A: Primary Cancer Prevention, Component B: Cancer Screening, and Component C: Health and Wellbeing of Cancer Survivors Applicants should submit an evaluation plan with key dates and milestones for the first year of the project. In subsequent funded years, evaluation is expected to include assessment of the degree to which the research fills important research gaps related to advancing health equity for cancer prevention and control.

Translation Plan Component A: Primary Cancer Prevention, Component B: Cancer Screening, and Component C: Health and Wellbeing of Cancer Survivors

At the start of the final project year, awardees are expected to submit plans for presenting findings to CDC, at professional meetings, at formal briefings for health and policy makers, and to the community residents where the intervention was implemented, highlighting opportunities for policy, environmental, and system changes (the lower tiers of the impact pyramid in Section

1.1 Background and Purpose). One or more reports of findings and recommendations for implementing, translating, adapting or scaling the intervention are expected to be submitted to peer-reviewed journals and disseminated through diverse media such as a study website, guidelines, toolkits, and policy briefs.

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39. National Academies of…