CDC-RFA-DP19-1905.pdf

Centers for Disease Control

National Center for Chronic Disease Prevention and Health Promotion

The CDC Cancer Genomics Program: Translating Research into Public Health Practice

CDC-RFA-DP19-1905

Application Due Date: 04/15/2019

The CDC Cancer Genomics Program: Translating Research into Public Health Practice

CDC-RFA-DP19-1905

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-DP19-1905. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

The CDC Cancer Genomics Program: Translating Research into Public Health Practice C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DP19-1905

E. Assistance Listings (CFDA) Number:

93.380 F. Dates:

1. Due Date for Letter of Intent (LOI): 03/15/2019

2. Due Date for Applications: 04/15/2019, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

Informational Conference Call will be held on 03/01/19 at 3:00pm EST. The conference call information is: 888-945-5897, Participant passcode: 8685234

G. Executive Summary:

1. Summary Paragraph:

The CDC Division of Cancer Prevention and Control (DCPC) announces the availability of Fiscal Year 2019 funds to implement DP19-1905, The CDC Cancer Genomics Program:

Translating Research into Public Health Practice. This program addresses the utilization of cancer genetic services as a strategy for cancer prevention and control. The primary outcomes of this NOFO are to increase screening of cancer family history and to increase the use of genetic counseling and testing for hereditary cancer syndromes, specifically Hereditary Breast and Ovarian Cancer (HBOC) Syndrome and Lynch Syndrome (LS), among individuals meeting recommendations for referral. This funding opportunity supports the implementation and evaluation of public health activities within four strategies to build the evidence base and disseminate best practices. These priorities will be accomplished by funding up to five https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov recipients to develop, implement, and evaluate state-level programs in cancer genomics.

Funding will support applicants to:

Increase organizational capacity to address public health priorities in cancer genomics Expand and develop surveillance systems to measure the hereditary cancer burden Educate the public on family cancer history as a risk factor for cancer Educate providers about family history screening and referring patients to cancer genetic services Develop partnerships to facilitate policy and systems changes that increase access to and use of cancer genetic services

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 5

d. Total Period of Performance Funding: $5,250,000

e. Average One Year Award Amount: $450,000

f. Total Period of Performance Length: 3

g. Estimated Award Date: 08/30/2019

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Hereditary cancer syndromes increase cancer risk and may present as multiple primaries, cancers diagnosed at advanced stages, and cancers diagnosed at younger ages. Individuals with hereditary breast and ovarian cancer syndrome (HBOC) face a higher risk for developing breast and ovarian cancers by age 70 years than do women in the general population (65/100 vs. 12/100 and 39/100

vs. 1/100, respectively). Similarly, those with Lynch syndrome (LS) have a higher lifetime risk for colorectal cancer than that of the general population (40/100 vs. 4/100, respectively).

Individuals with HBOC, LS or a pathogenic variant in other genes have also been shown to have a higher risk of prostate, pancreatic, and uterine/endometrial cancers. In addition to increased cancer risk for the individual, family members have a high probability of carrying the same gene mutations. Individuals with a hereditary cancer syndrome may present with specific patterns of personal and family history of cancer, which can be evaluated using recommendations by the United States Preventive Services Task Force (USPSTF), National Comprehensive Cancer Network (NCCN), and Evaluation of Genomic Applications in Practice and Prevention (EGAPP).

Screening for cancer risk using family history may indicate increased risk for multiple cancer types or varying genetic mutations. While most recommendations focus on genetic testing for a single gene or specific genetic syndrome, the advent of multi-gene panel genetic testing requires new approaches to patient-provider communication, systems and policy change, and patient education. With decision support, individuals who have a high risk of developing cancer can make informed risk management decisions to reduce their cancer risk.

HBOC and LS present opportunities for public health intervention in cancer prevention and control through the evaluation of family history and identification of inherited mutations that increase cancer risk. The goal of this NOFO is to: 1) increase the collection of cancer family history and provider discussion about family history, and 2) increase the rate of genetic counseling and testing for hereditary cancer syndromes, specifically HBOC and LS, in individuals meeting recommendations for referral. These outcomes can be achieved by implementing strategies and activities in surveillance, provider education, public education, and systems and policy change.

The USPSTF found sufficient evidence to recommend the screening of family cancer history for referral to genetic counseling and testing for HBOC. In addition, EGAPP concluded that all newly diagnosed colorectal cancers should be screened for LS. NCCN has released consensus-based guidelines on the evaluation of HBOC and LS for tumor testing and germline testing. In addition, the most recent recommendation from NCCN on Prostate Cancer discusses considerations for genetic testing for patients with a strong family history.

A previous funding opportunity in this area, DP14-1407, funded state health departments to implement activities in education, surveillance and policy. From this funding opportunity, we have learned about the importance of collaborating with state cancer programs and state surveillance systems to implement and evaluate program activities. Other lessons learned include the importance of program structure and capacity to carry out key functions, such as program management, health education, data analysis, and evaluation.

b. Statutory Authorities This program is authorized under the following sections: Section 317(k)(2) of the Public Health Service Act (PHS Act), Section 42 U.S.C. 247b (k)(2), and Section 301(a) of the PHS Act, 42 U.S.C. 241(a).

c. Healthy People 2020 This cooperative agreement is most closely aligned with HP2020 goals relevant to genomics (https://www.healthypeople.gov/2020/topics-objectives/topic/genomics).

d. Other National Public Health Priorities and Strategies N/A

e. Relevant Work This NOFO builds upon the work of a previous funding opportunity in this area, DP14-1407, https://www.healthypeople.gov/2020/topics-objectives/topic/genomics which funded state health departments to implement activities in education, surveillance and policy (https://www.cdc.gov/cancer/dcpc/about/genomics/index.htm).

This NOFO primarily relates to the four National Center for Chronic Disease Prevention and Health domains (https://www.cdc.gov/chronicdisease/center/nccdphp/how.htm) of action to transform the nation’s health and support Americans to take charge of their own health: 1) epidemiology and surveillance, 2) environmental approaches, 3) health care system interventions, and 4) community programs linked to clinical services.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-term Outcomes Intermediate Outcomes Long-Term Outcomes

Strategy 1:

Surveillance

Improved data on hereditary cancer burden and utilization of cancer genetic services

Strategy 2:

Public Education and Awareness

Increased public awareness and knowledge about family history of cancer and benefits of genetic counseling and testing

Strategy 3:

Provider Education

Increased provider knowledge and self-efficacy to apply professional recommendations, clinical communication, record family health history, use referral tools as recommended by USPSTF and to refer to genetic counseling and testing

Increased proportion of individuals report that they are aware of their family history of cancer and report having discussed their associated cancer risk with a provider

Increased number of providers using family history screening and tumor testing to identify individuals at high risk for hereditary cancer Improved referral patterns for cancer genetic services Increased health systems with universal tumor screening protocols for LS among newly diagnosed cancer patients

Increased appropriate utilization of genetic counseling and genetic testing

Increased proportion of individuals at high risk for a hereditary cancer who are counseled on and utilize risk management strategies https://www.cdc.gov/cancer/dcpc/about/genomics/index.htm https://www.cdc.gov/chronicdisease/center/nccdphp/how.htm

Strategy 4:

Partnerships

Policy and systems change to improve access to and utilization genetic counseling, testing and risk management for HBOC and

LS

Reduced system barriers for the access of screening and genetic services

i. Purpose Recipients of this NOFO will be asked to implement and evaluate activities and strategies in surveillance, provider education, public education, and the development of partnerships to facilitate policy and systems change in order to increase awareness of family history as a cancer risk factor, and the use of genetic counseling and testing for HBOC and LS.

ii. Outcomes Intermediate outcomes:

Increased proportion of individuals report that they are aware of their family history of cancer and report having discussed their associated cancer risk with a provider

Improved referral patterns for cancer genetic services o This outcome relates to health systems and payers having policies and practices that are concordant with recommendations for family history screening and tumor testing and referral of patients with increased risk to genetic counseling and testing.

o This could also include health systems and clinics having established referral networks for cancer genetic services, including tele-genetics, or phone-based genetic counseling.

o In addition, health systems and clinics having policies and practices that help facilitate cascade screening would be included under this outcome.

Long-term outcomes:

Increased appropriate utilization of genetic counseling and genetic testing

iii. Strategies and Activities Recipients shall develop or expand programs focused on the implementation of innovative strategies through activities addressing hereditary cancer syndromes, specifically HBOC and LS.

Programs shall assist in the development of the public health practice evidence-base describing how to implement genomic-based approaches to cancer prevention and control, which may serve as a model for other state and national work.

Applicants should utilize several activities within each strategy, all of which should be informed by ongoing data collection and surveillance. Applicants should consider approaches at the policy, community, organizational, interpersonal, and intrapersonal levels when developing and proposing activities. Applicants should develop activities consistent with each of the four strategies below. While examples of activities are provided below, applicants should not consider these activities a menu from which to select, unless otherwise indicated. The development and implementation of activities should be driven by local context, partnerships, program capacity, and available data or evidence.

Each applicant should take a state-based approach, meaning that all funded activities should be implemented and evaluated within a particular state’s geographic boundaries. However, applicants are allowed to apply jointly for funding across multiple organization types and jurisdictions (e.g., multiple states, multiple local jurisdictions, border areas, Tribes and state/local jurisdictions). Applicants must clarify in their project narrative and work plan which strategies will be implemented by each entity.

All programs are required to exercise strong skills in program management with minimum requirements described below.

Program Management

1. Hire or retain adequate and qualified staff to manage the program. Core staff should include staff with expertise in program management, program evaluation, and epidemiology.

2. Develop an evaluation plan, with CDC guidance, based on the four strategies; plan should be updated, as needed, throughout the period of performance. Plan must include stakeholders, program description, evaluation questions, process and outcome measures, plans for data collection, analytic methods, reporting methods, and dissemination strategies. Evaluation plan is due six months after award.

3. Participate in required CDC meetings and trainings to facilitate the accomplishment of proposed outcomes.

Programs are required to implement activities in alignment with Strategies 1-4. If applicants choose to apply jointly for funding, the application must still address strategies 1-4, but each entity may address one or all of the strategies. Applicants must clarify in their narrative which strategies each entity will be implementing.

Strategy 1 - Surveillance

1. All funded programs are required to work with a state cancer registry to conduct surveillance activities. Required surveillance activities include:

Analysis of cancer registry data to estimate cancer burden associate with hereditary cancer syndromes (yearly analysis of most recent data available) Mapping or GIS-related analyses to understand overlap between burden and access (completed once in first year of funding)

2. Optional surveillance activities to conduct in collaboration with the state cancer registry may include but are not limited to:

Pilot testing of new registry fields Monitoring of cancer genetic testing use or tumor testing (for LS) through laboratory reporting to the registry

3. All funded programs are required to field questions on a state Behavioral Risk Factor

Surveillance System (BRFSS) survey at least once during the period of performance.

Funding for the fielding of questions on BRFSS must be included in the program budget.

Questionnaire content will be consistent across all funded programs. Questions to be fielded will be decided by recipients and CDC within 3 months of funding award.

4. Funded programs are strongly encouraged to use, expand, or develop additional data sources for measuring and monitoring cancer genetic services use (e.g. family history screening, referrals to cancer genetic services, utilization of genetic counseling and testing, use of differing types of genetic tests such as cancer genetic panel tests, universal screening of Lynch Syndrome, and/or cascade screening). This may include, but is not limited to, claims data, clinical or health systems data, or other survey data.

5. All data-related activities and products, including results summaries, data briefs, posters/presentations, or publications should be reported to CDC yearly as part of reporting requirements.

6. All programs should develop dissemination plans for analyses of surveillance or other data. Dissemination plans should address methods for dissemination to all relevant stakeholders.

Strategy 2 - Public Awareness and Education

1. Topics for activities in public awareness and education may include, but are not limited to:

Screening of family history for cancer risk

Benefits of genetic counseling and testing for individuals at increased risk Types of genetic testing available, including panel-testing Limitations of direct to consumer testing options Existing privacy protections for genetic information, such as GINA Decision making on genetic testing Cancer screening considerations for those at increased risk Methods to manage or reduce cancer risk

2. Educational efforts should discuss cancer types associated with hereditary cancer syndromes, specifically HBOC and LS, including breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, and uterine/endometrial cancer.

Genes associated with HBOC and LS include BRCA1/2 and the mismatch repair genes. In addition, genes other than BRCA1/2 and the mismatch repair genes may be included in education efforts, as relevant, such as when discussing additional cancer types, other hereditary cancer syndromes, and multi-gene panel testing.

3. The types of resources that should be developed and disseminated to aid in education efforts may include, but are not limited to: pamphlets, brochures, and fact sheets; decision aids; public service announcements and other campaign materials; websites and other digital/online resources; instructional or educational videos; and family history collection tools.

4. Modes of activity implementation can include, but are not limited to: small media, one-on-one education, group education, mass media or digital media outreach, or multi-component educational approaches.

5. In high-risk populations, programs should explore conducting activities beyond the individual level and consider family-based educational activities that may promote use of cascade screening.

Strategy 3 - Provider Education

1. Topics for provider education, whether addressing primary care or specialty providers, may include, but are not limited to:

Conducting family history screening and ordering tumor testing Engaging in shared decision making in the use of genetic counseling and/or testing Appropriately referring to cancer genetic services Working with payers to get cancer genetic services covered Recommending appropriate cancer screening for those with a family history of cancer Interpreting and discussing results of genetic testing, including results of genetic panel tests Recommending risk management practices for high risk patients

2. Educational efforts should discuss cancer types associated with hereditary cancer syndromes, specifically HBOC and LS, including breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, and uterine/endometrial cancer.

Genes associated with HBOC and LS include BRCA1/2 and the mismatch repair genes. In addition, genes other than BRCA1/2 and the mismatch repair genes may be included in education efforts, as relevant, such as when discussing additional cancer types, other hereditary cancer syndromes, and multi-gene panel testing.

3. Modes of activity implementation may include, but are not limited to CME courses or opportunities; workshops; mentoring programs; tumor boards, case conferences, or journal clubs; webinar or website engagement; or curriculum for trainees.

4. Dissemination of provider resources, including training on how to use these resources is required. Resources could include, but are not limited to paper or digital versions of clinical decision aids, guides to genetic testing options and interpretation, family history collection and screening tools, genetic counseling and testing referral guides, and/or guides on managing high risk patients.

Strategy 4 – Partnerships as a tool for Policy/Systems Change (see Collaborations section) The following partnership activities are required:

1. Collaborations with a state cancer registry and a state BRFSS will be used to implement activities in Surveillance (Strategy 1). These data will be used to evaluate activities, develop health education materials, and for program planning.

2. Collaborations with health systems, academic health centers, community clinics, other clinical locations, and/or private and public payers to facilitate policy and systems change are required. These collaborative activities may include, but are not limited to:

Stakeholder education about hereditary cancer syndromes Dissemination of data on hereditary cancer burden to stakeholders and decision makers Reducing structural barriers for access to cancer genetic services through navigation programs, promoting telephone genetic counseling, or tele-genetics, etc.

Provider assessment and feedback programs using surveillance data Clinical and patient decision aids on genetic testing options, including panel testing Assessing and disseminating health plan coverage policies, gaps in coverage, and providing model plans for coverage Assessing health systems policies and practices in family history and cancer genomics Assessing health systems needs and priorities in family history and cancer genomics Dissemination of guides for providers on how to work with payers on coverage for cancer genetic services State and federal policy education and analysis Promotion and dissemination on health system or clinic best practices on family history screening and/or tumor screening

3. Collaborations with other state cancer programs, specifically the Comprehensive Cancer

Control Program, the Breast and Cervical Cancer Early Detection Program, and the Colorectal Cancer Control program are required. Activities may include, but are not limited to:

Meeting regularly for information sharing Cross-promotion of events and activities

Sharing or providing technical expertise Co-sponsoring or jointly implementing activities or events Promoting and sharing resources Collecting and sharing data Leveraging partnerships and other program resources Integrating genomics into existing educational materials and resources from other programs

The following partnership activities are strongly encouraged:

1. Developing relationships with community-based organizations (e.g. non-profit organizations, community clinics, advocacy organizations, academic institutions, etc.) to aid in the implementation of activities and dissemination of information.

2. Developing relationships with other relevant chronic disease programs that address topics in genomics, such as Familial Hypercholesterolemia.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

Collaborations with a state cancer registry and the state BRFSS are required, and a letter of support from each must be provided. These letters of support should express willingness to work with the applicant to provide access to data and/or field questions.

Collaborations with other state cancer programs, such as the Comprehensive Cancer Control Program, the Breast and Cervical Cancer Early Detection Program, and the Colorectal Cancer Control Program are required. Letters of support from these programs are strongly encouraged.

All letters of support should be combined into one pdf document, name the “LettersSupport”, and upload it as a pdf at www.grants.gov

b. With organizations not funded by CDC:

In order to effectively implement activities within policy and systems change, collaborations and engagement with key stakeholders will be required. Potential collaborators for these activities should be identified in the application. Letters of support from potential collaborators are strongly encouraged.

Applicants are strongly encouraged to collaborate with relevant community-based organizations.

Such stakeholders can help develop the necessary partnerships for successful implementation, increase reach of the program, improve dissemination, and provide for sustainability at the end of CDC funding. Applicants should, when possible, provide evidence of prior collaborations or experience working with such partners (e.g. memorandum of agreement, memorandum of understanding, data use agreements) or documentation of intent to work collaboratively (e.g., letters of support, letters of intent).

All letters of support should be combined into one pdf document, name the “LettersSupport”, and upload it as a pdf at www.grants.gov

2. Target Populations http://www.grants.gov/ http://www.grants.gov/

If desired, applicants can choose to target populations who have a greater burden of HBOC and/or LS, or populations who have lower levels of access and utilization of cancer genetic services in their jurisdiction. If an applicant elects to target a specific population, data sources used to define and describe the target population(s) should be cited in the justification. Target populations should not be limited to demographic characteristics, e.g. race/ethnicity and gender.

Research has indicated that the following populations may be relevant for targeted efforts in cancer genomics, however additional target populations may be identified and justified by the applicant:

Ashkenazi Jewish populations o Those of Ashkenazi Jewish ancestry are more likely to carry BRCA mutations.

African American/Black o Some research indicates that this population has lower utilization rates of genetic counseling and testing.

o African American women have higher rates of triple negative breast cancer.

Cancer survivors o Individuals diagnosed with certain cancers may benefit from genetic counseling and testing as part of the diagnostic and treatment process.

Relatives of high risk individuals (BRCA1/2 or Lynch carriers) o Those with a family history of cancer or with a known mutation in their family are more likely to be mutation carriers and are at increased risk for cancer.

Rural communities o Genetic counselors are most often located in urban centers, and research indicates that rural populations may have less access.

a. Health Disparities Previous research indicates that those in rural communities and members of minority racial/ethnic groups, particularly African Americans, are less likely to utilize cancer genetic services when clinically indicated. This NOFO encourages recipients to consider these groups when implementing activities. In addition, these groups are among the ones identified in the “Target Populations” section. Recipients may also choose to focus on target populations that are more likely to carry cancer-causing genetic mutations and have a greater need for cancer genetic services.

iv. Funding Strategy

NA

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Evaluation and performance measurement enables CDC and recipients to track implementation of recipient strategies and activities (process evaluation) and determine progress on achieving the period of performance outcomes (outcome evaluation). It will facilitate the CDC in 1) assessing the extent to which the activities and strategies were successfully implemented; 2) demonstrating whether activities produced the expected outputs and the projected outcomes; 3) informing program planning, decision making, and continuous program quality improvement; and 4) determining the public health impact of implementation of cancer genomics into practice.

CDC will use information collected through review of program documents, recipient surveys, and other reporting requirements to measure recipient progress in the following areas:

Use of available evidence in the development of new activities;

Use of surveillance data to further inform program practice;

Implementation of activities described in the work plan;

Use of rigorous evaluation methods to record the implementation strategy and to measure progress towards objectives and outcomes for each activity in the work plan;

Planning program sustainability and resource allocation; and Use of dissemination strategies to promote program resources, activities, and outcomes.

Progress made towards addressing short, intermediate, and long-term outcomes described in the NOFO and outputs that affect change described by the Science Impact Framework will be used to measure the overall impact of the Cancer Genomics Program.

As part of activities, recipients may collect and analyze data from multiple sources. Recipients must develop a data management plan (DMP) for all public health data collected as part of this funding opportunity. The DMP should include:

A description of the data to be collected or generated in the proposed project;

The standards to be used for the collected or generated data;

Mechanisms for, or limitations to, providing access to the data, including a description for the provisions for the protection of privacy, confidentiality, security, and intellectual property, or other rights;

Statement of the use of data standards that ensure all documentation that describes the method of collection, what the data represent, and

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified

While there is no template for a DMP, this link may be a helpful resource and guide as you create your DMP: https://www.icpsr.umich.edu/icpsrweb/content/datamanagement/dmp/plan.html. Your CDC Project Officer will work with you to determine if a DMP is needed for any of your data sources.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

https://www.icpsr.umich.edu/icpsrweb/content/datamanagement/dmp/plan.html

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

Performance measures serve as an integral source of data for CDC's evaluation efforts. The applicant must demonstrate the ability to monitor program performance by establishing a performance measurement strategy, including a description of the data source that will be used and frequency at which it will be measured. The tables below provide the performance measures which recipients will be required to report. In instances where more than one performance measure per outcome is provided, recipients must select at least one of the measures. Since this NOFO does not require recipients to conduct specific activities, measures may be altered to accommodate programs approach to strategy implementation and target population focus, as appropriate, with the approval of the project officer. Required performance measures must be collected and reported to CDC at least once over the period of performance.

Required performance measures:

Outcome Performance Measure

Intermediate outcomes

Increased proportion of individuals report that they are aware of their family history of cancer and report having discussed it with a medical provider.

1. Number of individuals who report that they have collected their family history of cancer

2. Number of individuals who report that they have discussed their family history of cancer with a medical provider

Improved referral patterns for cancer genetic services

1. Number of health systems and payers that have policies and practices that are concordant https://www.cdc.gov/grants/additionalrequirements/ar-25.html with recommendations for family history screening and referral of high-risk patients to genetic counseling and testing.

2. Number of health systems and clinics that have established referral networks for cancer genetic services, including tele-genetics, or phone-based genetic counseling.

3. Number of health systems and clinics that have policies and practices that help facilitate cascade screening.

Long-term outcomes

Increased appropriate utilization of genetic counseling and genetic testing

1. Number of individuals who are referred to, or utilize genetic counseling and/or testing when indicated

While there are no required performance measures for the short-term outcomes presented in the logic model, recipients should monitor progress toward achieving these outcomes. Recipients will work with project officers to monitor progress using the suggested, but not required, performance measures and outputs below.

Outcome Performance Measure/Output

Improved data on hereditary cancer burden and utilization of cancer genetic services

1. Number of data sources used for program planning or resources (such as development of educational materials, use in surveillance, and use to address performance measures/evaluation).

Increased public awareness and knowledge about family history of cancer and benefits of genetic counseling and testing

1. Number of events (in-person, digital, etc.), resources, or products developed, implemented, and/or disseminated to a general audience.

Increased knowledge and self-efficacy to apply professional recommendations, clinical communication, record family health history, use referral tools as recommended by USPSTF and to refer to genetic counseling and testing

1. Number of health care providers who report they are knowledgeable and confident in their ability to evaluate a patient’s family history of cancer and refer to cancer genetic services when appropriate

2. Number of specialty providers who report they are aware of universal genetic testing practices or identifying newly diagnosed cancer patients who may benefit from cancer genetic services.

3. Number of providers who participate in educational opportunities, or who receive program materials

Policy and systems change to improve access to and utilization of HBOC and LS genetic counseling, testing and risk management

1. Number of partners and stakeholders engaged in program efforts to create systems and policy change

2. Assessment of policy, systems, and environmental factors that may improve access and utilization of HBOC and LS counseling, testing, and risk management

3. Assessment of health plans to identify policies consistent with recommendations in referral to genetic counseling, testing, and risk management for high-risk patients.

Reduced system barriers for the access of screening and genetic services

1. Assessment of barriers and facilitators for accessing cancer genetic services

2. Dissemination of results of assessment to relevant partners and stakeholders

Recipients will be responsible for developing and implementing a comprehensive formal written evaluation plan that defines both process and outcome (short-term, intermediate, and long-term) measures that will be evaluated during the three-year period. Evaluation efforts should focus both on the implementation of activities and measuring progress towards objectives and program outcomes. Program evaluators may consider using the constructs described in the Consolidated Framework for Implementation Research and the CDC Evaluation Framework to guide their evaluation of key activities. Program outcomes should be measured at the population level in the state in which the activities are occurring. If an applicant will perform activities in multiple states, evaluation should occur in each state in which the activity was implemented. Recipients will be responsible for developing evaluation reports that summarize their implementation and outcomes findings. Through the receipt of evaluation reports, the CDC will be able to identify and disseminate best practices.

In the first 6 months of the period of performance, applicant must provide an initial evaluation and performance plan to indicate how they will identify progress in implementing program strategies, activities, and achieving program outcomes. This evaluation plan should:

Identify key evaluation stakeholders, how they will be engaged, and their role in program planning and evaluation.

Describe how evaluation stakeholders will utilize evaluation findings.

Include a logic model to illustrate program design and its relationship to program outcomes. Programs should start with the logic model in this NOFO. However, the logic model may be adapted or altered to suit program goals with the approval of the CDC project officer.

Describe specific, measurable, and realistic yearly program objectives that are indicative of progress toward program outcomes.

Describe plans and processes for data collection for all indicators, performance measures, and/or outcomes.

Describe how evaluation findings will be used to enhance implementation efforts.

Recipients must provide an evaluation report summarizing key findings at the completion of each budget period and an updated version of the evaluation plan. The annual evaluation report should:

Report details on the implementation of each activity to the level of detail required for replicability in other public health settings.

Describe direct costs of developing and implementing each activity described in the work plan, including estimates of staff time.

Describe the roles of partners to facilitate the implementation of each activity in the work plan, focusing on the provision of additional public health capacity (e.g. improve reach, access to target population, technical skills, data access).

Report progress toward objectives and outcomes through indicators and process measures, including data sources that were used and methods for primary data collection.

Describe facilitators, challenges and barriers to implementing activities as described in the work plan Describe whether activities have yielded the expected outcomes and what progress has been made in addressing program outcomes.

c. Organizational Capacity of Recipients to Implement the Approach Recipients must be able to readily implement a cancer genomics program upon receipt of award.

To ensure that recipients are able to execute program requirements and meet period of performance outcomes, applicants must demonstrate: 1) a staffing plan and project management structure sufficient to implement activities and achieve the project outcomes with clearly defined staff roles; 2) capacity to implement the program work plan and evaluation plan; 3) relevant experience to implement the activities and achieve project outcomes; and 4) support from organization leadership.

Staffing and Project Management

Program should describe a staffing plan, as well as a plan to maintain staff to manage the program Applicants should submit an Organizational Chart and CVs showing the core staff and their assigned duties Core staff should include staff with expertise in program management, program evaluation, and epidemiology Programs should also demonstrate access to subject matter expertise in public health cancer genomics and/or clinical genetics

Capacity and Infrastructure

Demonstrate staff that have experience or organizational experience with conducting activities in cancer genomics Demonstrate prior experience collaborating with state-based surveillance systems that include state cancer registries and state BRFSS Demonstrate prior experience building relationships and collaborating with partners to conduct activities in cancer genomics Demonstrate capacity and infrastructure by describing any staff, activities, and partners at the state- or organizational-level that will able to plan, prioritize, and implement cancer prevention and control strategies in cancer genomics Discuss readiness to implement activities in cancer genomics (e.g. currently available staff, existing partnerships, partner commitment to activities, leadership support for program goals, relationships with target populations or program stakeholders, organizational experience conducting similar activities or strategies)

Previous Experience

Describe experience working with state cancer registry, BRFSS, and other surveillance systems to identify high risk cancer populations, collect program data, or to conduct other programmatic activities Describe previous experience using population-level or surveillance data for program planning and assessment Describe previous experience working with target populations, if any Describe previous experience conducting public education, provider education, and/or systems and policy change activities Describe experience collaborating with CDC-funded program and community-based organizations to accomplish goals Describe experience developing program evaluation plans and evaluating programmatic activities Describe your organization’s process for program improvement processes based on continuous assessment and evaluation Describe previous experience reporting on program outcomes and activities (e.g.

conference presentations or posters, publications, data briefs, etc.)

Support from Organizational Leadership Applicants should demonstrate support from organizational leaders for conducting work in cancer genomics. This support could come from a relevant organizational leader (such as medical directors, heads of cancer or chronic disease programs, chronic disease directors, department chairs, etc.). Letters of support are encouraged.

d. Work Plan Applicants must provide a detailed work plan. The work plan must include period of performance outcomes (outcomes to be achieved over the life of the cooperative agreement- see logic model) and annual objectives (yearly objectives that work toward the achievement of the period of performance outcomes) that are specific, measureable, achievable, realistic, and time-phased.

Applicants should provide a detailed work plan for the first year, while a high-level plan for subsequent years in support of NOFO outcomes will suffice.

At a minimum the work plan should include:

Per strategy, applicants should identify their period of performance outcomes.

These should reflect the intended outcomes in the program logic model.

Applicants should describe the indicator that will be used to measure each outcome.

Applicants should include a brief description of how they will monitor and report progress on outcomes.

Annual objectives should then be developed per period of performance outcome.

These annual objectives should also include an indicator to measure progress.

Activities that will support each annual objective should then be described.

Activities described in the project narrative and work plan must be in alignment with the proposed outcomes and the program strategies listed in the NOFO.

Activity descriptions should include a brief synopsis of the activity, the population targeted, the staff supporting or responsible for the activity, if any partners will be involved in the activity, and any evaluation measures for the activity or outputs from the activity.

If a particular activity leads to multiple outcomes, it should be described under each relevant outcome measure

Work Plan template

Outcome [#]: [What is the outcome being addressed?]

Description: [Include a brief description of how this outcome will be operationalized. If it was not described in the NOFO, how does it fit within the scope of the NOFO?] Measure: [How will this outcome be measured?] Data source: [From what data source will you measure changes in this outcome?]

Direction of change:

[Increased, decreased]

Baseline: [if available, what is the current number of units of this outcome?]

Target: [If relevant, how many units do you expect to see change in the period of performance?]

Annual Objective [#]: [Based on the activities being implemented in the next twelve months, write a SMART objective describing the expected change in the next twelve months. It should show progress towards a change in the outcome within the period of performance.]

Indicator: [What will be the indicator of success in meeting this objective? If this is a process measure, do not fill out the fields below.] Data source: [From what data source will you be able to measure changes in this outcome?]

Direction of change:

[Increased, decreased]

Unit of measure: [what is the unit you expect to see measurable change?]

Baseline: [if available, what is the current number of units meeting this objective?]

Target: [How many units would you expect to see change in the next 12 months?]

Activity [#.##] [should match the identifier in the Project Narrative]

Strategy: [Of strategies 1-4 described in the NOFO, which one is being addressed by this activity?] Brief Activity Description: [What is being done to affect change? This brief description of the activity should be similar to the complete description provided in the project narrative text.] Population affected: [Which population is being targeted by the intervention? If it is a population of convenience, please describe. If it is a target population described in the NOFO, please describe.] Staff supporting this activity: [List the staff persons who will be responsible for this activity.] Partnership: [Describe the intended contributions of specific partnerships in this activity. Are they providing capacity to facilitate this activity (e.g. improve reach, access to target population, technical skills, data)?] Process measure: [What measure will be used to judge whether the activity was completed?]

It is recommended that recipients use the first six months to collect and summarize baseline measures that describe the health outcomes in cancer genomics, access to care, and use of genetic services in the state(s) in which the program is being implemented. This gives recipients an opportunity to further tailor their activities described in the work plan to the gaps identified. This information will be provided to CDC as part of a Baseline Program Assessment. This assessment will ask recipients to provide specific and detailed information on each strategic area and identify strengths associated with their program in implementing their program plan, weakness they may face in implementing their program plan, opportunities the program may be able to leverage as they implement their program plan, and threats to program implementation. Recipients will receive guidance and a template for the Baseline Program Assessment from CDC at the time of award.

All applicants should include a site visit to CDC in Atlanta, GA for two days in Year 1. This meeting with all recipients will occur within the first three months of award. Funds to cover costs associated with this travel should be included in the budget.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting…