POC SOW 25.07.2023.pdf

| POC Statement of Work dated July 25, 2023 Page 1 of 5

STATEMENT OF WORK

Patterns of Care (POC) Study: Diagnosis Year 2021 (Prostate Cancer, Ovarian Cancer, and

Small Intestines Cancer)

Dated July 25, 2023

Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work.

A. Background

The National Cancer Institute (NCI) Patterns of Care (POC) studies describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. POC Studies are conducted to satisfy a Congressional directive (under Public Law 100- 607, Sec. 413 (a)(2)(C) adopted on November 4, 1988) to the NCI to “assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessment in the biennial reports…”. To satisfy the directive and to update and enhance the utility of the POC Studies, a working group including representatives from the NCI’s Divisions of Cancer Control and Population Sciences and Cancer Treatment and Diagnosis and a representative from the American Cancer Society was developed to review knowledge gaps in cancer therapy dissemination and to develop priority areas for study. The group reached a consensus that a gap remains regarding factors associated with guideline use of biomarker tests and targeted therapy. Furthermore, there is limited information about the effects of the COVID-19 pandemic on cancer screening, diagnosis, treatment, and receipt of supportive/palliative care among individuals diagnosed with cancer and little information regarding treatment patterns for cancers of the small intestines. Therefore, this POC Study shall investigate patterns of care for patients with prostate, ovarian, and small intestines cancers. The Study will also collect data on documentation of palliative care and patient financial impacts of the COVID-19 pandemic in the medical record.

B. Objectives

The primary objectives of this POC Study are to: 1) describe the use of recommended biomarker tests which shall be verified with the treating physician/physician office staff or with a unified medical record (record with all inpatient and outpatient records in a single file) or complete medical records (all inpatient and outpatient cancer treatment records obtained from more than one hospital/healthcare system/medical practice); and 2) describe the use of targeted therapy which shall be verified with the treating physician/physician office staff or with a unified or complete medical records. Other objectives are to: 3) describe the use of adjuvant therapy, which shall be verified with the treating physician/physician office staff or with a unified or complete medical records; 4) characterize the practice patterns in different communities; 5) compare the patterns of treatment: surgery, radiation therapy, systemic therapy, (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, and other adjuvant therapy) over time and by age, sex, race/ethnicity, and insurance status; 6) describe comorbidities and the effect of co-morbid conditions on treatment; 7) describe treatment by hospital characteristics (i.e., for profit vs. not for profit, teaching vs. non-teaching, bed size, etc.); 8) describe the use of diagnostic tests and compare their use by demographic variables; 9) abstract information documented in the medical record on

| POC Statement of Work dated July 25, 2023 Page 2 of 5 delays or changes in diagnosis, treatment, and supportive/palliative care among individuals diagnosed with cancer specifically due to the COVID-19 pandemic; 10) assess the incidence of cancer recurrence and metastasis following initial diagnosis; and 11) describe medical record documentation of patient financial impacts due to the COVID-19 pandemic potentially affecting cancer care.

C. Technical Requirements

The Contractor shall perform the following tasks:

1. Abstract from the medical record all items on the abstract form as specified in the Diagnosis Year 2021 POC Data Acquisition Manual, which will be provided with the Request for Quotes.

Verify with the treating physician/physician’s office staff or by abstracting a unified or complete medical records the biomarker tests completed, radiation therapy, systemic therapy (targeted therapy, chemotherapy, immunotherapy, hormonal therapy), and other adjuvant therapy given to each patient to treat their selected cancers. Participation in treatment protocols and therapy provided shall also be verified with the treating physician/ physician’s office staff or with unified or complete medical records. If additional physicians who provided therapy are identified, they shall be contacted by the Contractor as well.

Multiple attempts shall be made, as needed, to obtain complete therapeutic information from the treating physicians. In the case of facilities with a unified or complete medical records, reviewing the unified or complete medical records shall be considered equivalent to reviewing the physician's office records. Review of hospital records that do not contain all of the inpatient and outpatient records shall not be considered equivalent to reviewing the physician’s office records. Additional information shall be collected on diagnostic tests, surgery, pathologic margins, tumor characteristics, tumor recurrence, and hospital and physician characteristics. Information on insurance status and discussions about palliative care and effects of the COVID-19 pandemic shall be abstracted from the medical record.

2. Identify a stratified random sample of prostate cancer cases diagnosed between January 1, 2021 and December 31, 2021 selected for data abstraction. Non-Hispanic Blacks, Hispanics, Asian/Pacific Islanders and Native American/Alaskan Natives shall be oversampled to obtain more stable estimates. Sampling shall also be by age group, stage, and tumor biomarker status where appropriate. Eligible cancer patients shall be sampled from cases age 20 years or older. Patients shall be ineligible if they have previous malignancies (except prior basal cell or squamous cell carcinoma of the skin), simultaneously diagnosed cancers of more than one site (e.g., a patient diagnosed with primary prostate and primary lung cancer simultaneously) or were diagnosed at autopsy or on death certificate only.

Identify a stratified random sample of ovarian cancer cases diagnosed between January 1, 2021 and December 31, 2021 selected for data abstraction. Non-Hispanic Blacks, Hispanics, Asian/Pacific Islanders and Native American/Alaskan Natives shall be oversampled to obtain more stable estimates. Sampling shall also be by age group, stage, and tumor biomarker status where appropriate. Eligible cancer patients shall be sampled from cases age 20 years or older. Patients shall be ineligible if they have previous malignancies (except prior basal cell or squamous cell carcinoma of the skin), simultaneously diagnosed cancers of more than one site (e.g., a patient diagnosed with primary ovarian and primary lung cancer

| POC Statement of Work dated July 25, 2023 Page 3 of 5

For small intestines cancer, identify a stratified random sample of cases diagnosed between January 1, 2021 and December 31, 2021 selected for data abstraction. Non-Hispanic Blacks, Hispanics, Asian/Pacific Islanders and Native American/Alaskan Natives shall be oversampled to obtain more stable estimates. Sampling shall also be by age, stage, and sex where appropriate. Eligible cancer patients shall be sampled from cases age 20 years or older. Patients shall be ineligible if they have previous malignancies (except basal cell or squamous cell carcinoma of the skin), simultaneously diagnosed cancers of more than one site (e.g., a patient diagnosed with primary small intestines cancer and primary lung cancer

3. The Contractor shall: 1) obtain local Institutional Review Board (IRB) approval as appropriate for their institution, 2) select eligible cases with assistance from the NCI DCCPS’ Biomedical Computing Contractor, 3) provide the Contracting Officers Representative (COR) with documentation regarding the sampling procedure and all data necessary to determine the appropriate sample for their registry, 4) obtain requested data from medical record review and physician/physician office staff contact, 5) follow up with multiple attempts to obtain the treatment data from each patients’ physician(s)/physician office staff, 6) abstract data obtained from the medical record onto data collection forms following the specification in the Diagnosis Year 2021 POC Data Acquisition Manual, 7) edit and collate the collected data, 8) enter the data into the abstracting software provided by the NCI or abstract directly from the medical record into the abstracting software with the appropriate consolidation of data from multiple sources, 9) appropriately sample new cases registered after the initial sample was drawn, 10) track study progress, noting successes and failures, and 11) upload the electronic databases to the NCI DCCPS’ Biomedical Computing Contractor.

4. The Contractor shall provide Progress Reports that shall include, but is not limited to:

a. a discussion of the activities and tasks completed.

b. a discussion of any barriers or challenges and plans to overcome them and lessons learned, if any.

c. a discussion of plans for the next reporting period (not required for Final Progress

Report).

d. tables presenting the number of abstracted cases with data collection completed during the current reporting period and cumulative since the start of the project.

Separate tables will be prepared by cancer site. Each table will present the number of abstracted cases by cancer site with data collection in four mutually exclusive categories: from complete medical charts (i.e., inpatient and outcome medical charts);

from physician verification forms (with or without medical charts); from hospital/inpatient medical charts only (i.e., no outpatient data); and unverified cases (i.e., cases with neither medical charts nor physician verification forms used for date collection). Each table will also present the total number of cases with data collection during the current reporting period and cumulative since the start of the project.

5. The Contractor shall designate one Abstractor/quality assurance individual to attend

Abstractor Training to discuss uniform and standardization of procedures for sampling cases from each registry and for the coding of variables under the Diagnosis Year 2021 POC Study.

The NCI Centralized Abstractor Training report (see table below) will include the name and position of person(s) who attended training and plans to implement training to conduct the Statement of Work.

| POC Statement of Work dated July 25, 2023 Page 4 of 5

6. The Contractor shall provide a Final Progress Report that will include technical progress inclusive of the work performed for the entire contract period of performance in the same level of detail as provided in the Quarterly Progress Reports. The Final Progress Report will also include:

a. Objectives of the project.

b. Work completed.

c. Problems and resolution of the problems.

d. The sampling process for the initial sample and for subsequently identified cases.

e. Result tables presenting number of abstracted cases as described for Quarterly

Progress Reports.

f. Number of cases with substantial (25% or more) missing data.

7. The Contractor shall submit deliverables as follows:

Deliverable Quantity Delivery

Schedule Deliver to

(1) NCI Centralized Abstractor Training Report

1 Due no later than 15 calendar days after the Abstractor Training.

CO, COR, and ncibranchbinvoices@mail.nih.gov

(2) Quarterly Progress Reports

3 Due no later than 10 calendar days after end of each quarterly reporting period.

(3) Electronic Database Files of Abstract submissions:

abstracted Prostate Cancer data

1 Due on or before the expiration date of the contract.

NCI DCCPS’ Biomedical Computing Contractor via the SEER*DMS portal or via file transfer protocol (FTP) for those registries not on SEER*DMS.

Also send certification that this deliverable was submitted in the appropriate system via email to CO, COR, and ncibranchbinvoices@mail.nih.gov

(4) Electronic Database Files of Abstract submissions:

abstracted Ovarian Cancer data

1 Due on or before the expiration date of the contract.

NCI DCCPS’ Biomedical Computing Contractor via the SEER*DMS portal or via file transfer protocol (FTP) for those registries not on SEER*DMS.

Also send certification that this deliverable was submitted in the

| POC Statement of Work dated July 25, 2023 Page 5 of 5

Deliverable Quantity Delivery Schedule

Deliver to

(5) Electronic Database Files of Abstract submissions:

abstracted Small Intestines Cancer data

1 Due on or before the expiration date of the contract.

NCI DCCPS’ Biomedical Computing Contractor via the SEER*DMS portal or via file transfer protocol (FTP) for those registries not on SEER*DMS.

Also send certification that this deliverable was submitted in the

(6) Final Progress Report with Abstract Submission

1 Due on or before the expiration date of the contract.

8. Quality Control (QC)

Identify a sample comprising 5% of randomly sampled POC cases to be re-abstracted for quality control purposes. This shall be done by a staff member other than the one who performed the initial medical record abstraction. Re-abstracting shall be conducted as the abstracts are completed, not at the conclusion of the study. The re-abstracted data shall be edited by the supervisor, marked “QC”, and uploaded with the other abstracts. Retraining of the abstracting staff shall occur as needed as the QC is performed.

9. Each Contractor shall complete the number of abstracts for its registry as proposed in its final quote. (The number of cases will be updated at the time of award to reflect the negotiated case counts).

Solicitation Instructions (Delete upon award)- For solicitation purposes, Quoter must propose a minimum of 125 prostate cancer cases, 50 ovarian cancer cases, and 25 small intestines cancer cases.

Quoter will initially propose the number of case abstracts its registry is proposing it can perform at the proposed price. This number can include no more than 50% of the total number of prostate cancer cases that were diagnosed in 2021 and reported to the Quoter/registry.

Case counts will change upon negotiation AND will be based on number of cases identified by your registry that it proposes to perform in the final quote. (Case counts per registry are subject to change, and will be negotiated after initial quote based on several factors to include the number of offers received and total number of cases proposed by Quoters overall.)