Implementation of Community Engagement Techniques to Increase Accrual of Prostate Cancer Patients to the PROMISE Trial, Accrual of Under-Represented and Disadvantaged Populations.

(This grant may also be referred to as Community Engagement Grant or CEG)


Applications Due: Friday, October 28, 2022

Project Start Date: January–February 2023

Questions: This email address is being protected from spambots. You need JavaScript enabled to view it.


Advancing Cancer Treatment uses a two-step application process: Online for personnel information and email for proposal submission.

Step 1:
Fill out the initial online application:

Be prepared to provide the following information:

• Project Title and Brief Description

• Principal Investigators and any additional project personnel, Name and Contact information

• Applying organization information, TAX ID/EIN, IRS Designation, and Grant Office contact name and information

Step 2:
Submit your proposal by email:

Once you complete the online application, you'll receive a confirmation email that outlines Sections A and B for the Project Proposal.

Send your proposal by email to This email address is being protected from spambots. You need JavaScript enabled to view it.

Background of the Community Engagement Grant

This RFP seeks applications to address the challenges in accruing Black, Hispanic, Asian and Native American men to the PROMISE Registry Study, with the expectation that successful applicants will develop approaches that will improve accrual of such individuals, not only to PROMISE, but to other registries and trials, as well.

Although academic medical centers (AMCs) play a crucial role in cancer clinical research, most cancer care takes place in the community setting. Expanding clinical registry or trial accrual beyond the AMC environment allows access to a larger and more diverse patient population treated in a variety of healthcare delivery settings. This can accelerate accrual to cancer clinical studies and increase the generalizability and relevance of study findings. Research in community settings reflects the complexity of cancer care delivery and must engage community oncologists to aid in developing care delivery approaches that can be implemented within usual clinical workflow.

ACT will provide funding to support evidence-based programs that improve understanding of and access to the PROMISE Registry among under-represented minority and underserved populations. Successful applicants will develop approach(es) that increase participation of such populations and demonstrate increased accrual of Black, Hispanic, Asian, or Native American men. The successful applicants will also commit that system(s) proposed to improve PROMISE accrual will be extended to all other clinical registry and trial accrual in which the responding group or institution participates.

Background on PROMISE Registry Study

The PROMISE Registry is an important study designed to prospectively define a population of men with prostate cancer (localized, biochemically recurrent or metastatic) in whom germline pathogenic variants, likely pathogenic variants and variants of uncertain significance in certain cancer risk genes (ATM, ATR, BRCA1, BRCA2, FAM175A, GEN1, HOXB13, MRE11A, PALB2 and XRCC2) exist. This study is led by Dr. Heather Cheng, MD, PhD of the University of Washington and Dr. Channing Paller, MD of Johns Hopkins University and is supported by Prostate Cancer Clinical Trials Consortium (PCCTC) to create a nationwide registry of 500 men as defined above. The broad goal of PROMISE is to facilitate a better understanding of the incidence and role of pathogenic variants in DNA repair genes in prostate cancer treatment responsiveness, disease characteristics, and overall survival. Approximately 5000 men will be evaluated to define a study population of 500.

Participants will be recruited and screened over a five-year period. Study participants will be asked to provide a saliva sample to be tested for germline cancer risk variants through Color Healthâ. If the results identify a pathogenic or likely pathogenic variant, an appointment with a genetic counselor from Color Healthâ will be scheduled to discuss the results which will be kept confidential and shared by patient doctors if patient chooses. All of these services are free to the patients and providers. There are no commercial / for profit interests involved. See Reference Section – end of document.

The structure of this study is such that accrual is expected to require much less oversight and input by personnel in institutional programs as all enrollment can be completed on line by a patient. Recognizing this may require substantial support for some men, this should, nonetheless, involve considerably less engagement by institutional personnel than most registries or trials. In addition, PROMISE provides phone assistance for individuals requesting assistance with enrollment completion. (https://clinicaltrials.gov/ct2/show/NCT04995198)

There are considerable data supporting the observation that racial, ethnic and socioeconomic disparities limit the access of several populations to all clinical registries and trials (1-3). Arguably, studies based on access to genomic testing (such as PROMISE Registry) pose even greater challenges (4-11).

For more information on PROMISE, please visit: www.prostatecancerpromise.org

Eligibility

  1. For profit and non-profit hospitals, cancer centers, and large practice groups as well as regional or state-based research collaboratives are eligible to apply. National cooperative groups funded directly by the NCI are not eligible to apply.
  2. Since the goal of this RFP is to increase substantially the accrual of underrepresented minority and underserved men to the PROMISE trial institutions, applicants must demonstrate access to sufficient baseline numbers of such individuals to meet the above-cited accrual objective (50 patients/2 years).

Reporting and Other Requirements

  • If a proposal is funded, contract includes:
    • Agreement to submit a brief status report every six months, including a financial accounting of resource expenditures.
    • Multi-year grant submissions are required to include 12-month milestones for the purpose of evaluating progress towards overall project goals. These milestones must be achieved in order to qualify for the following year of funding.
    • Notify ACT in writing of any changes in address affecting the grant's principal investigators (PI), change in PI while the grant is active, or changes in the party or parties accepting responsibility for the grant.
    • Identify Advancing Cancer Treatment as a funder of the research in scientific reports and papers. When possible, please provide the web address: http://www.actclinicaltrials.org
    • Submit a final report including a non-technical, scientific description of work accomplished, challenges met, and financial accounting of resource expenditure during the conduct of the grant.
    • Agreement to share process and best practices with others through publication or through other channels supported by Advancing Cancer Treatment.

Submission Process

Initial applications can be completed and submitted here.
Proposals should be received by Friday, October 28, 2022.

Application:
Complete portion A of this application in no more than five pages

Project title:

  1. Effort Description

Abstract:

  1. Describe your approach and supporting evidence that the approach can provide a reliable and sustainable accrual mechanism for your catchment area. Describe catchment area.
    • Provide numbers and data on catchment area, including demographics that substantiate ability to enroll underrepresented minority and underserved men: >50 Black, Hispanic, Asian or Native American individuals to enroll in the PROMISE trial and undergo genetic testing on or before February 28, 2025. 
    • Comment on challenges of accrual in this catchment area and how you will address them.
    • A plan to sustain the infrastructure developed to accomplish this accrual objective beyond February 28, 2025.
  2. Provide a summary of the tools, technology, data and other resources that will be utilized.
    • Outline how data will be collected
    • Describe how patients would be recruited to PROMISE
    • Describe the institutional environment, resources and support and how that environment will facilitate the objectives of this project
    • Comment on scalability
  3. Timetable: Provide a timetable for the project with monthly/quarterly benchmarks.
  4. Mid-Grant Milestones: Two-year grant applications to include mid-grant milestones approximately 12 months) for the purpose of evaluating progress towards the overall project goals. Your project should provide a target number of accruals that can be reasonably achieved by end of Year One. These milestones must be achieved in order to qualify for the following year of funding.

The following are NOT included in the 5-page limit:

  1. Project Budget, Personnel, Funding History and Project Investigator
  2. Budget: Provide a detailed budget, broken down by year 1 and 2, if applicable. Indirect Costs are limited to 12% or less.
  3. Project personnel: Provide the name, title, role and responsibilities of all individuals who will be involved in the project, including the Principal Investigator (PI)/Co-PI(s). Indicate the percent effort that each person is expected to devote to the project.
  4. Funding history: If applicable, indicate any other sources of funding for the proposed or related projects, including the amounts and granting organizations.
  5. Project Investigator Biographies: Provide bios of all key project personnel and collaborator(s), preferably in NIH format or similar format that is abbreviated to emphasize experience relevant to this proposal. More information on this format can be found at: https://grants.nih.gov/grants/forms/biosketch.htm

References

  1. Seruga B, Sadikov A, Cazap EL, et al. Barriers and challenges to global clinical cancer research. Oncologist. 2014;19(1):61-67. doi:10.1634/theoncologist.2013-0290
  2. Cartmell KB, Bonilha HS, Simpson KN, Ford ME, Bryant DC, Alberg AJ. Patient barriers to cancer clinical trial participation and navigator activities to assist. Adv Cancer Res. 2020;146:139-166. doi: 10.1016/bs.acr.2020.01.008. Epub 2020 Feb 24. PMID: 32241387; PMCID: PMC8623462.
  3. https://www.fightcancer.org/sites/default/files/National%20Documents/Clinical-Trials-Landscape-Report.pdf
  4. Cragun D, Weidner A, Lewis C, et al. Racial disparities in BRCA testing and cancer risk management across a population-based sample of young breast cancer survivors. Cancer. 2017;123(13):2497-2505. doi:10.1002/cncr.30621
  5. Ademuyiwa FO, Salyer P, Tao Y, et al. Genetic counseling and testing in African American patients with breast cancer: a nationwide survey of US breast oncologists. J Clin Oncol. Published online October 18, 2021. doi:10.120
  6. Saulsberry K, Terry SF. The need to build trust: a perspective on disparities in genetic testing. Genet Test Mol Biomarkers. 2013;17(9):647-648. doi:10.1089/gtmb.2013.1548
  7. Racial and Ethnic Disparities in Genetic Testing at a Hereditary Breast and Ovarian Cancer Center Eloise Chapman-Davis M.D., Zhen Ni Zhou M.D., Ph.D, Jessica C. Fields M.D., Melissa K. Frey M.D, Bailey Jordan B.S, Katherine J. Sapra M.P.H., Ph.D., Sudeshna Chatterjee-Paer M.D., Ann D. Carlson M.S., C.G.C. & Kevin M. Holcomb M.D. Journal of General Internal Medicine volume 36, pages 35–42 (2021)
  8. Racial/Ethnic Disparities in Genomic Sequencing Daniel E. Spratt, MD; Tiffany Chan, MA; Levi Waldron, PhD et alJAMA Oncol. 2016;2(8):1070-1074. doi:10.1001/jamaoncol.2016.1854
  9. Disparities in Genetic Testing: Thinking Outside the BRCA Box Michael J. Hall and Olufunmilayo I. Olopade Journal of Clinical Oncology 2006 24:14, 2197-2203
  10. New study results presented by Foundation Medicine and collaborators at ASCO21 on cancer care underscore importance of equitable access to precision medicine advances. News release. Foundation Medicine; June 4, 2021. Accessed June 6, 2021. https://www.foundationmedicine.com/press-releases/aa904bd1-4854-44e9-8d03-24b5af5ff392.
  11. Martin AR, Kanai M, Kamatani Y, et al. Clinical use of current polygenic risk scores may exacerbate health disparities. Nat Gen. 2019;51(4):584-591