HT942526LCRPPCOSA_GG.pdf

This program announcement must be read in conjunction with the General Application Instructions, version CD26_01.

Program Announcement for the Defense Health Agency

Lung Cancer Research Program Patient-Centered Outcomes and Survivorship Award

Funding Opportunity Number: HT942526LCRPPCOSA

Pre-Application Due: August 18, 2026

Application Due: September 02, 2026 https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

FY26 Lung Cancer Patient-Centered Outcomes and Survivorship Award 2

Content

Before You Begin 3

Basic Information Summarizes the funding opportunity, funding details, submission deadlines and review dates

Eligibility Details eligibility factors for the applicant organization and Principal Investigator

Program Description Describes the program mission and intent of the Patient-Centered Outcomes and Survivorship Award; provides key award information and considerations; and outlines funding details

Application Contents Presents the two-step application process and instructions for preparing a pre-application and full application

Submission Requirements Provides locations for application packages, instructions for submitting pre-applications and full applications, and describes application verification

Application Review Information Outlines the processes for application compliance review, pre-application and full application selection/notification, and risk assessment. Also, details the review criteria for pre-application screening and both tiers of the CDMRP application review process – Peer Review and Programmatic Review

Federal Award Notices Outlines what a successful applicant can expect if recommended for funding

Post-Award Requirements References policy requirements for funded research; outlines reporting requirements and restrictions related to Principal Investigator changes and institutional award transfers

Other Information Outlines criteria for administrative actions including application rejection, modification, withdrawal and withhold

Appendix 1 Includes a checklist for all full application components to facilitate application submission

Appendix 2 Acronym List

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Before You Begin

• Active SAM.gov, eBRAP.org and Grants.gov registrations are required for application submission. User registration for each of these websites can take several weeks or longer.

Each applicant must ensure their registrations are active and up to date prior to application preparation.

• Read this funding opportunity announcement in the order it is written before beginning to prepare application materials. It is the responsibility of the applicant to determine whether the proposed research meets the intent of this funding opportunity and that all parties meet eligibility requirements.

• To support application preparation, additional resources are available including an application process FAQ, a Guide for Intragovernmental & Intramural Applicants and a CDMRP Video Series detailing the application process.

Who to Contact for Support

This document uses internal links; you can go back to where you were by pressing the Alt + left arrow keys (Windows) or command + left arrow keys (Macintosh) on your keyboard.

Click to be taken to additional guidance and instructions within the General Application Instructions (GAI).

eBRAP Help Desk

301-682-5507 help@eBRAP.org

Questions regarding funding opportunity submission requirements, as well as technical assistance related to pre-application or intramural application submission.

Grants.gov Support Center

800-518-4726 International: 1-606-545-5035 support@grants.gov

Questions regarding Grants.gov registration and Workspace.

https://sam.gov/ https://ebrap.org/eBRAP/public/index.htm https://grants.gov/register https://cdmrp.health.mil/#:%7E:text=Frequently%20Asked%20Questions%20%C2%BB https://cdmrp.health.mil/#:%7E:text=Guide%20for%20Intragovernmental%20%26%20Intramural%20Applicants https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Journey%20of%20an,Tier%20Review%20Process mailto:help@eBRAP.org mailto:support@grants.gov https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01

Section Shortcuts Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Lung Cancer Patient-Centered Outcomes and Survivorship Award 4

1. Basic Information About the Funding Opportunity

Summary: The fiscal year 2026 (FY26) Lung Cancer Research Program (LCRP) Patient- Centered Outcomes and Survivorship Award (PCOSA) promotes evidence-based and patient-centered approaches to improve health and lung cancer related outcomes and enhance the patient experience in defined populations. Research must address at least one of the FY26 LCRP areas of emphasis in the Health Outcomes and Survivorship category.

Distinctive Features:

• This funding mechanism requires the research team to include an advocate who is a lung cancer patient/survivor or caregiver.

• This funding mechanism allows proposed projects to include translational or clinical research, including pilot clinical trials.

Funding Details: The Congressionally Directed Medical Research Programs (CDMRP) expects to allot roughly $1.95M to fund approximately two PCOSA applications with total cost caps of $975,000 per award. The maximum period of performance is 3 years. It is anticipated that awards made from this FY26 funding opportunity will be funded with FY26 funds, which will expire for use on September 30, 2032. Awards supported with FY26 funds will be made no later than September 30, 2027.

Submission and Review Dates and Times

• Pre-Application (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern Time (ET), August 18, 2026

• Application Submission Deadline: 11:59 p.m. ET, September 02, 2026

• End of Application Verification Period: 5:00 p.m. ET, September 04, 2026

• Peer Review: October 2026

• Programmatic Review: January 2027 Announcement Type: Initial Funding Opportunity Number: HT942526LCRPPCOSA Assistance Listing Number: 12.420

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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2. Eligibility Information

2.1. Eligible Applicants

2.1.1. Organization

Extramural and intramural U.S. Department of War (DOW) organizations are eligible to apply, including foreign and domestic organizations, for-profit and nonprofit organizations, and public or private entities.

2.1.2. Principal Investigator

Independent investigators affiliated with an eligible organization are eligible to be named Principal Investigator (PI) on the application, regardless of ethnicity, nationality or citizenship status.

The PI must be an independent investigator at any career level.

An investigator may be named on only one application as PI for the Patient-Centered Outcomes and Survivorship Award program announcement.

2.2. Cost Sharing

Cost sharing is not an eligibility requirement.

2.3. Other

Awards are made to eligible organizations, not to individuals. Refer to the GAI for additional recipient qualification requirements.

https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Content_Form_Full_App_Submission:%7E:text=pre%2Dapplication%20submission.-,Extramural%20Organization%3A,-A%20foreign%20or https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=Intramural%20DOW%20Organization%3A%20A%20subset%20of%20intragovernmental%20organizations%3B%20refers%20specifically%20to%20DOW%20organizations%2C%20including%20DOW%20laboratories%2C%20DOW%20military%20treatment%20facilities%2C%20and/or%20DOW%20activities%20embedded%20within%20a%20civilian%20medical%20center.

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Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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3. Program Description

The Defense Health Agency Contracting Activity (DHACA) is soliciting applications to this funding opportunity using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The CDMRP is the program office managing this FY26 funding opportunity as part of the Lung Cancer Research Program (LCRP). The CDMRP is located within the Defense Health Agency Research and Development (DHA R&D), which is a part of the Department of Defense, DOD, herein referred to using the secondary title Department of War, DOW. Congress initiated the LCRP in 2009 to promote innovative and competitive research focused on the development of integrated disciplines to identify, treat, and manage early curable lung cancer (excluding mesothelioma). Appropriations for the LCRP from FY09 through FY24 totaled $245.5 million (M). The FY26 appropriation is $20M.

The vision of the FY26 LCRP is to eradicate deaths and suffering from lung cancer to better the health and welfare of Service Members, Veterans and the general public. As such, the LCRP will support and integrate research from multiple disciplines for risk assessment, prevention, early detection, diagnosis, management, and treatment for the control and cure of lung cancer and its sequelae.

To meet the intent of the funding opportunity, all applications must address at least one of the FY26 LCRP Areas of Emphasis in a way that can lead to or directly effect a breakthrough and have a major impact. The LCRP developed a strategy to address multiple issues in lung cancer research over the cancer continuum of care spectrum that will be considered for funding under the LCRP. These areas of emphasis are critical gaps in cancer research, care, and/or patient outcomes that, if addressed, will lead to reduced suffering from lung cancer and improved quality of life of Service Members, Veterans and the general public.

Simply identifying an area of emphasis is not sufficient.

3.1. Intent of the Patient-Centered Outcomes and Research Award

The FY26 LCRP Patient-Centered Outcomes and Survivorship Award (PCOSA) supports high-risk, high-reward research studies that span the spectrum of survivorship, health outcomes and comparative effectiveness research, including quality of life, symptom and side effect management, resilience, and co-morbid conditions.

The overall intent of the FY26 LCRP Patient-Centered Outcomes and Survivorship Award is to promote evidence-based and patient-centered approaches to improve health- and lung cancer-related outcomes and enhance the patient experience in defined populations. Research studies may include, but are not limited to:

• Studies to examine and improve quality of life, decision-making, and symptom and side effect management (e.g., toxicity of treatment, palliative/supportive care, psychological distress and anxiety).

• Studies to investigate the impact of prevention, diagnostics, treatment or health care delivery approaches on health outcomes.

• Studies to assess the relationship(s) between behavioral, cognitive, and/or social functioning in relation to lung cancer detection, initiation, progression, treatment and rehabilitation.

• Studies into the psychological health and well-being of those affected by lung cancer (e.g., patients, family members).

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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• Development and testing for efficacy of lifestyle interventions and symptom management approaches to minimize disease risk and maximize quality of life.

3.1.1. Areas of Emphasis for the PCOSA

To meet the intent of the funding opportunity, all applications must address at least one of three areas of emphasis for health outcomes and survivorship in a way that can lead to or directly effect a breakthrough and have a major impact.

• Health Outcomes and Survivorship

○ Identify and understand the long-term and cumulative effects of lung cancer and its treatment(s) on quality of life for patients and families.

○ Identify and understand the impact of comorbidities on survivorship care in all stages of lung cancer.

○ Reduce differences among high-risk groups and populations.

3.1.2. Key Elements for the PCOSA

Key elements of this award mechanism are as follows:

• Impact: The Patient-Centered Outcomes and Survivorship Award intends to support research that demonstrates the potential to have a major impact on patient outcomes.

Research should challenge paradigms with respect to impact on patient care and outcomes.

Proposed projects may include translational or clinical research, including pilot clinical trials.

Impactful research will accelerate the movement of promising ideas into clinical applications and advance quality of life and survivorship.

• Study Design: Applications should clearly articulate the chosen design of the study. Basic studies should demonstrate research strategy, feasibility, and how the study relates to the human experience with lung cancer. Studies entailing retrospective or prospective recruitment should define the type of architecture of the study (e.g., descriptive, correlational, field experimental, meta-analyses). Applications should define study populations. The rationale should support the chosen study design with statistical evaluation to back the design. Applications should describe questionnaires in sufficient detail to justify interpretation of potential results. Studies utilizing animal models are not supported by this funding opportunity and will be withdrawn.

• Preliminary Data: The Patient-Centered Outcomes and Survivorship Award requires preliminary data for all studies that propose the active (prospective) recruitment of human subjects. Studies not proposing active recruitment of human subjects are not required to present preliminary data but should be supported by sound reasoning and relevant literature.

• Patient Advocate Participation: Applications to the Patient-Centered Outcomes and Survivorship Award funding opportunity are required to include an advocate who is a lung cancer patient/survivor or caregiver. As part of the research team, the lung cancer advocate would assist in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. As a lay representative, the lung cancer advocate should be active in a cancer advocacy organization. Interactions with other team members should be well-integrated and ongoing, not limited to attending seminars and semi-annual meetings. The role of the lung cancer

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Lung Cancer Patient-Centered Outcomes and Survivorship Award 8 advocate should be focused on providing objective input on the research and its potential impact for individuals with or at risk for lung cancer.

• Clinical Study Initiation: Applications to the Patient-Centered Outcomes and Survivorship Award are required to include detailed plans for initiating a clinical study within the first year, including U.S. Food and Drug Administration (FDA) Investigational New Drug/Investigational Device Exemption (IND/IDE) application submission plans within 60 days of the award.

3.1.3. Other Important Considerations for the PCOSA

Relevance to Military Health: The LCRP seeks to support research that is relevant to the health care needs of Service Members, Veterans and their Families. The LCRP strongly encourages investigators to consider the following characteristics as examples of how a project may demonstrate relevance to military health:

• Use of military or Veteran populations, biospecimens, data/databases, or programs in the proposed research.

• Collaboration with DOW or U.S. Department of Veterans Affairs (VA) investigators.

• Explanation of how the project addresses an aspect of lung cancer that has relevance or is unique to the military, Veterans, other MHS beneficiaries, or Family readiness of Service Members, including environmental exposures other than tobacco.

All investigators applying to FY26 LCRP funding opportunities are encouraged to consider leveraging resources from the LCRP-funded Lung Cancer Biospecimen Resource Network (LCBRN) if retrospectively collected human anatomical substances and correlated clinical data are relevant to the proposed studies. Samples from the LCBRN are currently available through the Cooperative Human Tissue Network (CHTN). To request LCBRN samples, contact the Division Coordinator for the CHTN Mid-Atlantic Division (email: CHTN-MidAtl@hscmail.mcc.virginia.edu) located at the University of Virginia.

In accordance with the National Defense Authorization Act for Fiscal Year 2026, Section 732, CDMRP does not support the conduct of painful research (U.S. Department of Agriculture pain category D or E) involving domestic cats or dogs, except for studies relating to military or service animals.

Clinical research and clinical trials are allowed for this funding opportunity.

All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research, such as those described in the STROBE, CONSORT, SPIRIT and ARRIVE 2.0 guidelines.

Applications from investigators within the DOW and applications involving multidisciplinary collaborations among academia, industry, the DOW, the VA and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, their Families and the American Public. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

The following encouragement is broadly applicable across many CDMRP programs, including the LCRP. A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic mailto:CHTN-MidAtl@hscmail.mcc.virginia.edu https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=considered%20clinical%20trials.-,Clinical%20Research%3A,-For%20the%20purposes https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Definition_List:%7E:text=or%20hardware%20procurement.-,Clinical%20Trial%3A,-As%20defined%20in https://www.strobe-statement.org/ https://www.nature.com/articles/s41591-025-03635-5#:%7E:text=SPIRIT%20and%20CONSORT%20are%20evidence,relevant%20empirical%20evidence%20where%20possible https://www.nature.com/articles/s41591-025-03668-w?fromPaywallRec=false https://arriveguidelines.org/arrive-guidelines

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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Cancer Task Force, CDMRP encourages applicants to review the recommendations and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY26 LCRP priorities.

3.2. Funding Instrument

The funding instrument for awards made under the program announcement will be grants

(31 USC 6304).

3.3. Funding Details

Period of Performance: The maximum period of performance is 3 years.

Cost Cap: The application’s total costs budgeted for the entire period of performance should not exceed $975,000. If indirect cost rates have been negotiated, indirect costs are to be budgeted in accordance with the organization’s negotiated rate. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate.

All direct and indirect costs of any subaward or contract must be included in the direct costs of the primary award.

The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 3 years.

The appropriateness of the budget for the proposed research will be assessed during peer review.

Direct Cost Restrictions: For this award mechanism, direct costs:

May be requested for (not all-inclusive):

• Travel in support of multi-institutional collaborations.

• Costs for one investigator to travel to one scientific/technical meeting per year. The intent of travel to scientific/technical meetings should be to present project information or disseminate project results from the FY26 LCRP Patient-Centered Outcomes and Survivorship Award.

https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=Period%20of%20Performance%3A%20The%20time%20interval%20between%20the%20start%20of%20a%20federal%20award%20and%20the%20planned%20end%20date.

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Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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4. Application Contents and Format

4.1. Application Overview

Application submission is a two-step process requiring both a pre-application submitted via the Electronic Biomedical Research Application Portal (eBRAP) and a full application submitted through eBRAP or Grants.gov. Depending on the submission portal, certain aspects of the application will differ.

Intramural DOW organizations submitting a full application should follow instructions for submission through eBRAP.

Extramural organizations submitting a full application must follow instructions for submission through Grants.gov.

4.2. Pre-Application Components

Pre-application submissions must include the following components.

Letter of Intent (LOI) (one-page limit): Provide a brief description of the research to be conducted. Include the area of emphasis under which the application will be submitted.

LOIs are used for program planning purposes only (e.g., reviewer recruitment) and will not be reviewed during either the peer or programmatic review. An invitation to submit a full application is NOT provided after LOI submission. Applicants are encouraged to develop pre-application and full application components concurrently and submit a full application AFTER successful submission of the pre-application.

• Pre-Application Relevance Questions: Provide responses in appropriate eBRAP data fields for the following two questions.

○ Is the applicant and/or collaborator(s) currently affiliated with the military and/or VA?

(Yes/No)

○ Does the proposed research include the use of military and/or VA resources (e.g., data, patient samples)? (Yes/No) If yes, specify the resource and how the resource will be accessed to conduct the proposed research (500-character limit, including spaces).

4.3. Full Application Components

Each application submission must include the completed full application package for this program announcement. See Appendix 1 for a checklist of the full application components.

(a) SF424 Research & Related Application for Federal Assistance Form (Grants.gov submissions only):

IMPORTANT: When completing the SF424 R&R, enter the eBRAP log number assigned during pre-application submission into Block 4a – Federal Identifier.

(b) Attachments:

Each attachment of the full application components must be uploaded as an individual file in the format specified and in accordance with the formatting guidelines in the GAI.

https://ebrap.org/eBRAP/public/index.htm https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=APPENDIX%202.%0AFORMATTING%20GUIDELINES https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=(a)%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20SF424%20(R%26R)%20%E2%80%93%20Application%20for%20Federal%20Assistance%20Form https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_Grants:%7E:text=IV.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20GRANTS.GOV https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Full_App_Submission_eBRAP:%7E:text=V.%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%C2%A0%20FULL%20APPLICATION%20SUBMISSION%20THROUGH%20eBRAP

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

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○ Attachment 1: Project Narrative (15-page limit): Upload as “ProjectNarrative.pdf”.

Describe the proposed project in detail using the outline below.

Applications proposing a pilot clinical trial must include preliminary data.

– Background: Present the scientific rationale behind the proposed research with relevant literature citations, sound rationale and/or preliminary data (if applicable) in support of the idea. Describe the need or gap in understanding survivorship, including how the proposed research may have a major impact on patient outcomes.

Articulate how the study will assess the relationship(s) between behavioral and social functioning in at least one of the areas of lung cancer initiation, progression, detection, treatment, and rehabilitation. State the area of behavioral health science to be studied (e.g., basic behavioral, quality of life, decision-making and/or cognitive function, educational interventions, symptom management).

– Objectives/Specific Aims/Hypotheses: Provide a description of the purpose and objectives of the study with detailed specific aims and/or study questions/ hypotheses.

– Research Strategy and Feasibility: Describe the study design, methods, and analyses in sufficient detail for evaluation including availability of resources (if applicable). Studies entailing retrospective or prospective recruitment should define the type of study (e.g., descriptive, correlational, field experimental, meta-analyses).

Study populations should be defined. Address potential problem areas and pitfalls and present alternative methods and approaches. Consult appropriate guidelines to ensure relevant aspects of rigorous and reproducible research are adequately planned for and, ultimately, reported. If using psychometric measures, describe their reliability and validity. If use of a biorepository, patient medical files, and/or meta-analysis is proposed, describe the data to be collected and the process or methodology to collect the samples (i.e., for biorepositories, the standardization of procedures for collection). Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the FDA or an international regulatory agency, if applicable. If human subjects or human anatomical samples will be used, include a plan for the recruitment of subjects or the acquisition of samples and document the experience of the PI and/or key collaborators in recruiting human subjects for similar projects. Basic studies should demonstrate the research strategy and feasibility and how the study relates to the human experience with cancer.

Describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study, including a description of the composition of the proposed study population in terms of sex, racial, and ethnic group, and an accompanying rationale for the selection of subjects. If women and minorities are excluded, to what extent the application provides a rational justification.

If funds for a pilot clinical trial are requested, details regarding the Clinical Trial Strategy must be described in Attachment 9.

○ Attachment 2: Supporting Documentation: Combine and upload as a single file named “Support.pdf”.

There are no page limits for these components unless otherwise noted. Include only components described below; inclusion of items not requested or viewed as https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Project%20Narrative%3A,-Attach%20as%20%E2%80%9CProjectNarrative https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Supporting%20Documentation%3A,-Combine%20and%20attach

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FY26 Lung Cancer Patient-Centered Outcomes and Survivorship Award 12 an extension of the Project Narrative will result in the removal of those items or may result in administrative withdrawal of the application.

References Cited: List the references cited in the Project Narrative using a standard reference format (include URLs, if available).

List of Abbreviations, Acronyms and Symbols: Provide a list of abbreviations, acronyms and symbols.

Facilities, Existing Equipment and Other Resources: Describe the facilities and equipment available for performance of the proposed project; include any additional facilities or equipment proposed for acquisition at no cost to the award. Indicate whether government-furnished facilities or equipment are proposed for use. If so, reference the original or present government award under which the facilities or equipment items are now accountable. There is not a standardized form for this information.

Publications and/or Patents: Include a list of relevant publication URLs and/or patent abstracts. If articles are not publicly available, then copies of up to five published manuscripts may be included in Attachment 2. Extra items will not be reviewed.

Letters of Support (one-page limit per letter is recommended): Provide individual letters signed by collaborating individuals and/or organizational officials demonstrating that the PI has the support and resources necessary for the proposed work. Letters from the PI’s Department Chair, or appropriate organization official, should also confirm that the PI(s) meet eligibility criteria. If applicable, provide a letter of support, signed by the lowest-ranking person with approval authority, confirming participation of intramural DOW collaborator(s) and/or access to military populations, databases or DOW resources. If applicable, provide a letter of support signed by the VA Facility Director(s), or an individual designated by the VA Facility Director(s), confirming access to VA patients, resources and/or VA research space.

Letter of Lung Cancer Advocate Commitment: Provide a letter from an advocate who is a lung cancer patient/survivor or caregiver confirming their commitment to the research project.

Use of DOW and/or VA Resources (if applicable): If the proposed research involves access to military and/or VA patient populations and/or DOW or VA resources or databases, describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Also include a plan for obtaining any required data sharing, memorandum of understanding or other agreements required to access and publish data. Refer to the GAI, Appendix 4, for additional considerations.

Inclusion Enrollment Report (only required if clinical research is proposed):

Provide an anticipated enrollment table(s) for the inclusion of women and minorities using the “Public Health Service (PHS) Inclusion Enrollment Report”, a three-page fillable PDF form, that can be downloaded from eBRAP. The enrollment table(s) should be appropriate to the objectives of the study with the proposed enrollment distributed on the basis of sex, race, and ethnicity. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, ethnicity or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement.

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Sex as a Biological Variable Strategy (two-page limit is recommended):

Describe the strategy for how sex will be considered as a biological variable. This strategy should include a brief discussion of what is currently known regarding sex differences in the applicable research area. Clearly articulate how sex as a biological variable will be factored into the data analysis plan and how data will be collected and disaggregated by sex. If needed, provide a strong rationale for proposing a single-sex study, based on justification from scientific literature, preliminary data or other relevant considerations. Refer to the CDMRP Directive on Sex as a Biological Variable in Research for additional information.

Intellectual and Material Property Plan (if applicable): Provide a plan for resolving intellectual and material property issues among participating organizations.

Research Sharing Plan: Describe the type of data or research resources (e.g., bio-specimen, analysis tool/software, training material) to be made publicly available as a result of the proposed work. Describe the mechanism (e.g., direct sharing, repository, mixed mode) by which data and resources generated during the period of performance will be shared with the research community and other affected communities, including clinical research participants. Include the name of the repository(ies) where scientific data and resources arising from the proposed study will be archived, if applicable. Identify and provide the rationale for any data or resources that will not be shared (e.g. for intellectual property, feasibility, cost or other considerations). The plan should also protect participant privacy, confidential and proprietary data, and performer/third-party intellectual property. Provide a milestone plan for disseminating data/results including when data and resources will be made available to other users. In cases where the study participant could potentially derive medical or other benefit from the information, explain whether the results of screening and/or study participation will be shared with the participant or their primary care provider, including results from any screening or diagnostic tests performed as part of the study.

Do not submit a copy of the National Institutes of Health Data Management and Sharing Plan or duplicate the Data Management Plan which will be requested only after a recommendation for funding is made.

Refer to the CDMRP Directive on Sharing Data and Research Resources for more information about the CDMRP’s expectations for making data and research resources publicly available.

○ Attachment 3: Technical Abstract (one-page limit): Upload as “TechAbs.pdf”.

Write the technical abstract using the outline below. Clarity and completeness within the space limits are highly important.

Background: Present the scientific rationale behind the proposed research project.

Area(s) of Emphasis: State the FY26 LCRP Area(s) of Emphasis the project addresses.

Hypothesis/Objective(s): State the hypothesis to be tested and/or objective(s) to be reached. Provide evidence or scientific rationale that supports the hypothesis and/or objective(s).

Specific Aims: State the specific aims of the study.

Study Design: Describe the study design, including appropriate controls.

https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://cdmrp.health.mil/pubs/pdf/CDMRP%20SABV%20Directive_Revised_MAR2025_signed.pdf https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Directive%20on%20Sharing%20Data%20and%20Research%20Resources https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Technical%20Abstract%3A,-Attach%20as%20%E2%80%9CTechAbs

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Lung Cancer Patient-Centered Outcomes and Survivorship Award 14

Impact: Summarize the potential impact of the proposed project toward the goal of reducing suffering from lung cancer. State explicitly how the research will ultimately accelerate the movement of promising ideas toward clinical applications.

Military Relevance: Describe how the study is relevant to military health.

○ Attachment 4: Lay Abstract (one-page limit): Upload as “LayAbs.pdf”.

The lay abstract should address the points outlined below in a manner that is readily understood by readers without a background in science or medicine. Avoid overuse of scientific jargon, acronyms and abbreviations. Do not duplicate the technical abstract.

– Summarize the objectives and rationale for the proposed research.

– State the FY26 LCRP Area(s) of Emphasis the project addresses.

– What population will the research help, and how will it help them?

– What are the potential applications, benefits, and risks of the anticipated outcomes?

– What are the likely contributions of the proposed research project to advancing research, patient care and/or quality of life?

– What is the potential benefit of the proposed study and the anticipated outcomes to

Service Members, Veterans and/or their Families?

○ Attachment 5: Statement of Work (three-page limit): Upload as “SOW.pdf”.

Refer to eBRAP for the Suggested SOW Format.

For guidance on preparing the SOW, refer to either the Example: Assembling a Clinical Research and/or Clinical Trial Statement of Work or Example: Assembling a Generic Statement of Work, whichever is most appropriate for the proposed effort. Include milestones for data or research resource(s) sharing.

○ Attachment 6: Impact Statement (one-page limit): Upload as “Impact.pdf”.

The Impact Statement should be written in manner that is readily understood by readers without a background in science or medicine. Describe the patient-centered approaches of the proposed research that may lead to a potential major impact on patient outcomes. Articulate how the research will accelerate promising findings toward clinical applicability and leverage results to maximize impact on near-term patient outcomes. Describe how the proposed research is relevant to at least one of the FY26 LCRP Areas of Emphasis for health outcomes and survivorship. The relevance of all research, including basic, should relate to patient outcomes and how it benefits those affected by lung cancer. Describe how the proposed research will accelerate progress towards reducing suffering from lung cancer. If applicable, describe how the anticipated outcomes of the proposed study will make an impact in understanding health differences between sexes.

○ Attachment 7: Patient Advocate Involvement Statement (two-page limit):

Upload as “Advocate.pdf”. The Patient Advocate Involvement Statement should be written by the PI. Provide the name of the lung cancer advocate and their affiliation to a cancer advocacy organization(s). Describe the integral roles that the lung cancer advocate will play in the planning, design, implementation, and evaluation of the research. Describe how the lung cancer advocate’s knowledge of current lung cancer issues and how their background will contribute to the research project.

https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Suggested%20SOW%20Format https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Clinical%20Research%20and/or%20Clinical%20Trial%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=Example%3A%20Assembling%20a%20Generic%20Statement%20of%20Work https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Lay%20Abstract%3A,-Attach%20as%20%E2%80%9CLayAbs https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Lung Cancer Patient-Centered Outcomes and Survivorship Award 15

○ Attachment 8: Statistical Plan and Data Analysis (no page limit): Upload as “StatsData.pdf”. Describe the statistical methodology and plan, including how it supports the stated hypothesis or objective. If an existing dataset is to be used, describe the dataset and how it supports the aims of the project. State the inclusion and exclusion criteria for the subjects with sound rationale for the criteria, if applicable. Describe the power analysis and whether it determined population numbers; if not, justify why the power analysis is not essential to the statistical evaluation. State whether the study will include univariate, bivariate or multivariate analyses. State the variables to be used in the main analysis; include covariates and how the data will be adjusted to account for covariates, if applicable. Stratification of data (if applicable) should be described and justified. For data management, describe methods for data collection (e.g., identifiers, confidentiality). Describe how the study will conform to the 1996 Health Insurance Portability and Accountability Act, if applicable. Explain data capture, verification and disposition, if applicable. Describe how data will be evaluated for reproducibility and adjusted for confounding variables. Articulate how large datasets will be evaluated, if applicable.

○ Attachment 9: Clinical Trial Strategy, required if submitting to the PCOSA – Pilot Clinical Trial Option (no page limit): Upload as “Clinical.pdf”. If the application requests funding for a clinical trial, this attachment is required.

− Describe the rationale for the proposed clinical trial. Provide a description of the intervention and the endpoints to be measured. Describe the type of clinical trial to be performed (e.g., prospective, randomized, controlled) and outline the proposed methodology in sufficient detail to show a clear course of action. Describe potential challenges and alternative strategies where appropriate.

− If the proposed clinical trial was initiated using other funding prior to this application, explain the history and background of the clinical trial and declare the source of prior funding. Specifically, identify the portions of the study that would be supported with funds from this award.

− Provide detailed plans for initiating the clinical study within the first year, including FDA IND/IDE application submission plans within 60 days of the award, if applicable.

Describe how data will be reported and how it will be assured that the documentation will support a regulatory filing with the FDA, if applicable.

− Indicate the access to the study population, recruitment plans, and inclusion/exclusion criteria. Describe the informed consent process. Describe the strategy for the inclusion of women and minorities appropriate to the objectives of the study; include a description of the composition of the proposed study population in terms of sex, racial, and ethnic group; and include a rationale for the selection of subjects. Provide anticipated enrollment table(s) with the proposed enrollment distributed on the basis of sex, race, and ethnicity using the PHS Inclusion Enrollment Report. The enrollment table(s) should be appropriate to the objectives of the study.

○ Attachment 10: Questionnaires and Other Data Collection Instruments, if applicable (no page limit): Upload as “Question.pdf”. The Questionnaires and Other Data Collection Instruments attachment should include a copy of the most recent version of questionnaires, data collection forms, rating scales, interview guides, or other instruments. For each instrument, describe how the information collected is related to the objectives of the study. Describe how and when the instrument(s) will be administered. Describe how the instrument(s) will be adapted to the subject population, if https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report https://ebrap.org/eBRAP/public/Program.htm#:%7E:text=n/a-,Public%20Health%20Service%20Inclusion%20Enrollment%20Report https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW https://ebrap.org/eBRAP/public/gai.htm?version=CD26_01#_Recipient_Qualification_Restriction_Info:%7E:text=%C2%B7-,Statement%20of%20Work%3A,-Attach%20as%20%E2%80%9CSOW

Basic Information | Eligibility | Program Description | Application Contents and Format | Submission Requirements Application Review Information | Federal Award Notices | Post-Award Requirements | Other Information

FY26 Lung Cancer Patient-Centered Outcomes and Survivorship Award 16 applicable. For each instrument, describe the potential burden for the subjects participating in the study.

○ Attachment 11: Relevance to Military Health Statement (one-page limit):

Upload as “MilRelevance.pdf”. The FY26 LCRP Programmatic Panel will evaluate the Relevance to Military Health Statement during programmatic review only. Identify how the proposed research will support mission readiness by filling a gap in cancer prevention, early detection/diagnosis, prognosis, treatment, quality of life, and/or survivorship that may have a profound impact on the health and well-being of Service Members, their Families, Veterans or other beneficiaries. Articulate how the proposed research will advance the knowledge and understanding of cancer, patient care, and/or treatment options in the MHS for the benefit of active-duty Service Members, Veterans and other military beneficiaries. Describe the anticipated short-and/or long-term outcomes of the proposed research and their potential impact on the basic health, welfare, and/or psychosocial wellness of active-duty Service Members, Veterans and other military beneficiaries. If active-duty military, military Families, and/or Veteran population(s) will be used in the proposed research project, describe the population(s), the appropriateness of the population(s) for the proposed study and the feasibility of using the population(s). If a non-military population will be used for the proposed research project, explain how the population simulates the targeted population (i.e., the Armed Forces, their Family members and/or the Veteran population).

○ Attachment 12: Representations (Grants.gov submissions only): Upload as “RequiredReps.pdf”. All extramural applicants must complete and submit the Required Representations document available on eBRAP.

○ Attachment 13: Suggested Intragovernmental/Intramural Budget Form (if applicable): Upload as “IGBudget.pdf”. If an intramural DOW organization will be a collaborator in the performance of the project, complete a separate budget for that organization using the Suggested Intragovernmental/Intramural Budget form available on eBRAP.

(c) Additional Application Materials:

The following are additional forms for application submission. Follow the instructions specific to the submission portal, as found within the GAI.

i. Research & Related Senior/Key Person Profile (Expanded)

○ Biographical Sketch

○ Current/Pending Support

Intragovernmental applicants must include their internally supported research and development programs.

ii. Research & Related Budget

iii. Project/Performance…