Statement of Work.docx

Statement of Work

Procurement Request #: 61577

Period of Performance: September 1, 2022 – August 31, 2023

Title: Should low risk (Gleason score 6) prostate cancer be considered cancer? Modeling potential outcomes of a change in nomenclature

SECTION 1 – BACKGROUND

The Gleason grading system is used to help evaluate the prognosis of men with prostate cancer using samples from a prostate biopsy. Together with other parameters, it is incorporated into a strategy of prostate cancer staging which predicts prognosis and helps guide therapy. Gleason scores range from 6 (low-grade) to 10 (high-grade) and are strongly associated with prognosis.1 Among the projected 248,530 new prostate cases in 2021 in the U.S.,2 half of those men will have low-risk tumors that pathologists rate as Gleason score 6 (GS6) (Grade Group 1: GG1) disease,3 the most common diagnosis.4 Multiple large longitudinal series, commencing in the mid-1990’s have reported excellent long-term outcomes for active surveillance of GS6.5-10 Strong evidence suggests that GS6 disease almost never (<0.1%) develops into aggressive cancer requiring treatment. Thus, multiple groups have questioned whether GS6 meets the clinical criteria of a cancer,11-13 and others have proposed renaming it IDLE (indolent neoplasm of epithelial origin)14 or INeRRT (indolent neoplasm rarely requiring treatment) following the example used for indolent thyroid tumors 15 and bladder tumors.16 A CDC-spearheaded NIH State-of-the-Science Conference from 2011 suggested “strong consideration should be given to modifying the anxiety-provoking term ‘cancer’ for this condition”.17

SECTION 2 – PURPOSE

Should low risk (GS 6) disease be considered cancer? We propose to contract with Fred Hutch Cancer Center, which houses the CISNET prostate group consortium, to model possible downstream implications of changing nomenclature of GS6 prostate cancer. These findings will be used to inform policy decisions on appropriate nomenclature for GS6 tumors.

SECTION 3 – SCOPE OF WORK

The scope of work is as follows:

There are many potential implications to a change in nomenclature, particularly for a highly prevalent cancer such as prostate. We propose a series of models to be conducted by the CISNET prostate cancer working group, housed at Fred Hutch Cancer Center, to explore impacts of a change in nomenclature on clinical treatment profiles to include the number of follow up biopsies, number of men requiring treatment, metastases, and prostate cancer deaths that may occur as a function of the change. Models may include other biomarkers or imaging tests that are often included in clinical active surveillance protocols.

The target audience for dissemination of results consists of medical providers who advise, consult, and treat newly diagnosed prostate cancer patients as well as those that may be involved in their medical and psychological care and payment of treatment and other services. This audience may consist of pathologists, urologists, radiation oncologists, medical oncologists, molecular biologists, bioethicists, psychometricians, economists, health services researchers, cancer registrars and reporters, and patient advocates.

Report Summarizing CISNET findings CISNET investigators, together with CDC collaborators, will produce a report on this project summarizing the comparative modeling of the outcomes of reclassifying GS6 cancers as non-cancers along with suggested clinical protocols for managing the reclassified GS6 patient.

We expect no ramifications for cancer registry operations that will still capture GS6 tumors as GS6.

SECTION 4 – TASKS TO BE PERFORMED

Task

Year 1

· Establish contract with Fred Hutch Cancer Center which houses CISNET PWG

· Engage Erasmus University and OR Health and Sciences University modeling groups in refinement of study scope and questions

· Develop key input parameters needed for model

· Develop modeling scenarios that reflect reliable information available for modeling and the research interest of CDC.

· Conduct modeling study

· Draft and finalize study report describing analysis and results

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

N/A

SECTION 6 – PERIOD OF PERFORMANCE

Sept 1, 2022 – Aug 31, 2023

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

· Summary of the kick-off meeting

· Summary of monthly conference call

· Project workplan

· Periodic progress reports

September 2022

· Draft model structure

· List of variables to parameterize the model

January 2023

· Make revisions to the drafted model structure

· Make revisions to the list of variables to parameterize the model

March 2023

· Begin analysis in the project

April 2023

· Submission of final project report to CDC

· The product of this research should include draft manuscripts to peer reviewed publications

August 2023

SECTION 8 – REFERENCE MATERIALS

1. Eggener SE, et al. Predicting 15-year prostate cancer specific mortality after radical prostatectomy. J Urol. 2011 Mar;185(3):869-75

2. American Cancer Society. Prostate at a glance. https://cancerstatisticscenter.cancer.org/?_ga=2.25768061.1959797463.1592161586-1247855393.1592161586#!/cancer-site/Prostate. Accessed October 6, 2021.

3. The ASCO Post. When Can Patients With Gleason 6 Prostate Cancer Safely Undergo Active Surveillance? A roundtable discussion. https://www.ascopost.com/issues/july-25-2018/when-can-patients-with-gleason-6-prostate-cancer-safely-undergo-active-surveillance/. Accessed June 14, 2020.

4. Jang TL, et al. More favorable tumor features and progression-free survival rates in a longitudinal prostate cancer screening study: PSA era and threshold-specific effects. Urology. 2006 Feb;67(2):343-8.

5. Tosian JJ, et al. Active Surveillance of Grade Group 1 Prostate Cancer: Long-term Outcomes from a Large Prospective Cohort. Epub: Eur Urol. Jan 2020.

6. Klotz L, et al. Long-term follow-up of a large active surveillance cohort of patients with prostate cancer. J Clin Oncol. 2015 Jan 20;33(3):272-7.

7. Anderson BB, et al. Extraprostatic Extension Is Extremely Rare for Contemporary Gleason Score 6 Prostate Cancer. Eur Urol. 2017 Sep;72(3):455-460.

8. Ross HM, et al. Do adenocarcinomas of the prostate with Gleason score (GS) ≤6 have the potential to metastasize to lymph nodes? Am J Surg Pathol. 2012 Sep;36(9):1346-52.

9. Stark JR, et al. Gleason score and lethal prostate cancer: does 3 + 4 = 4 + 3? J Clin Oncol 2009; 27: 3459.

10. Haffner MC, et al. Tracking the clonal origin of lethal prostate cancer. J Clin Invest. 2013 Nov;123(11):4918-22.

11. Eggener SE, et al. Gleason 6 Prostate Cancer: Translating Biology into Population Health. J Urol. 2015 Sep;194(3):626-34.

12. Carter HB, et al. Gleason score 6 adenocarcinoma: should it be labeled as cancer? J Clin Oncol. 2012 Dec 10;30(35):4294-6.

13. Ahmed HU, et al. Do low-grade and low-volume prostate cancers bear the hallmarks of malignancy? Lancet Oncol. 2012 Nov.

14. Esserman LJ, et al. Addressing overdiagnosis and overtreatment in cancer: a prescription for change. Lancet Oncol. 2014.

15. Nikiforov YE, et al. Nomenclature Revision for Encapsulated Follicular Variant of Papillary Thyroid Carcinoma: A Paradigm Shift to Reduce Overtreatment of Indolent Tumors. JAMA Oncol. 2016 Aug 1; 2(8): 1023–1029.

16. Epstein JI, et al. The World Health Organization/International Society of Urological Pathology consensus classification of urothelial (transitional cell) neoplasms of the urinary bladder. Bladder Consensus Conference Committee. Am J Surg Pathol. 1998 Dec:1435-48.

17. Ganz PA, et al. National Institutes of Health State-of-the-Science Conference: role of active surveillance in the management of men with localized prostate cancer. Ann Intern Med. 2012 Apr 17;156(8):591-5.

SECTION 11 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

Permissible vendor(s) should have demonstrated expertise in the development, conduct, and reporting of high visibility systematic reviews and/or the planning, convening, and facilitation of consensus conferences for federal clients.

SECTION 12 – EVALUATION FACTORS

A. Award: This task order will be awarded to the contractor whose quote is considered to be the most advantageous to the Government, price and other factors identified below considered. Technical factors will be more important in the evaluation than price. The Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance.

B. Notice of Intent to Award Contract without Discussions: The Government reserves the right to evaluate quotes and award a task order without conducting discussions with the Contractors.

C. Technical Evaluation:

Suggested technical evaluation for this RFTOQ. Evaluation Factors listed below will be evaluated on a Pass/Fail basis. Yellow sections in the descriptors below should be completed for each requirement.

Technical Approach:

Contractors shall provide a discussion of their technical approach for providing the services required for this task order. This discussion shall be in the contractor’s own words; not simply a regurgitation of the requirements listed. This criterion will be evaluated according to the extent that it reflects a clear understanding of the subject areas to be accomplished and on the soundness, practicality, and feasibility of the contractor’s technical approach for providing the services required for this task order.

Management Plan:

Contractors shall provide a management plan that describes their approach for managing the work outlined in this task order by demonstrating their understanding of the labor requirements listed in this RFTOQ. Contractors shall provide (1) a detailed description of how conflicts are managed; (2) a plan to ensure client satisfaction; and (3) a measurement of fiscal responsibility and accountability paying particular attention to the deliverable timeline in this task order. This criterion will be evaluated according to the soundness, practicality, and feasibility of the contractor’s management plan for this task order.

Staffing Plan:

Contractors shall provide a detailed statement of staffing proposed for this task order, including (1) resumes from key personnel (limited to _25_ pages) outlining the credentials and background of key management, professional, and technical personnel to be used for this task order, including the percent time on this and other projects; (2) a detailed plan that describes current staff available for this task order and how the team will interface with CDC, as well as descriptions of methods used to recruit professional and technical staff as workloads increase, and/or emergencies or staff turnovers occur; and (3) staffing plan must include a PhD-level social scientist with extensive experience collecting quantitative/qualitative data and conducting health disparities research with African American women and breast cancer survivors. This criterion will be evaluated according to the soundness, practicality, and feasibility of the contractor’s staffing plan for this task order.

Similar Experience:

Provide information reflecting the contractor’s organizational capacity for projects similar in complexity and scope. Proposed staff and company should have demonstrated experience in in survey methodology, developing and fielding online surveys, EHR pathology data and chart abstraction, and conducting research in cancer health disparities. In addition, experience with preparation of OMB packages is desired. This criterion will be evaluated to determine appropriate experience of assigned personnel and of the company.

HHSAR Provision, 352.239-73: Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 504 Authoring Tools 602 Support Documentation 603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

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