Attachment 1 SOW 06.12.23.pdf

June 12, 2023

Attachment 1 - Statement of Work

Pediatric Proton and Photon Therapy Comparison Cohort Coordinating Center

1.0 BACKGROUND

The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics

(DCEG), National Cancer Institute (NCI) carries out studies to quantify second cancer risks associated with ionizing radiation exposures in pediatric cancer patients. The Branch has a specific interest in the risk of second tumors following proton therapy in children, because concerns have been raised about whole-body scatter doses from neutrons, brain necrosis and other late effects including second tumors.

Pediatric radiation oncology is undergoing rapid changes due to the widespread introduction of proton therapy. By reducing high-dose exposure to nearby normal tissue protons should reduce a wide-range of serious adverse-effects, such as second cancers. To date, no studies have directly evaluated the potential benefits or risks of protons for children, and some case series have raised concerns about some serious unanticipated side-effects, such as brain necrosis. There is widespread agreement amongst the clinical and scientific community that large-scale collaborative efforts are urgently required to address these questions. The REB/DCEG aims to create the first prospective cohort study including pediatric cancer patients treated with proton therapy and a comparison group of similar patients treated with photon therapy. This new cohort will build upon a foundation created by the US Pediatric Proton Consortium Registry (PPCR).

This state-of-the-art registry, currently includes 18 US proton therapy centers and has recruited more than 3,000 pediatric proton patients who have actively enrolled in the registry since 2012.

Thus, the coordinating center study team has developed infrastructure and expertise critical to management of contributing study centers and data collection processes. For the Pediatric Proton and Photon Therapy Comparison Cohort, there is a critical need to obtain data from proton patients who are not enrolled in the PPCR and a control group of patients treated with photon therapy, which will allow for comparisons between patients treated with proton versus photon therapy. To obtain a sufficient number of proton and photon therapy patients, data will need to be obtained from multiple different proton and photon therapy centers, requiring a coordinating center to ensure uniform procedures and systems for data handling across the centers. Data from the PPCR will be incorporated into the new cohort study to form the foundation of the proton therapy cohort, so it is important that equivalent data is obtained from proton and photon centers using the same procedures and systems. A primary aim for NCI in the development of the

Pediatric Proton and Photon Therapy Comparison Cohort will be to quantify the subsequent cancer risks after proton therapy compared to photon therapy.

2.0 OBJECTIVE

The Contractor shall assemble existing data from medical records for a group of pediatric cancer patients who received proton or photon therapy. The objective is to acquire a high-quality data set through uniform acquisition of standard data elements across multiple participating proton and photon treatment centers, with data acquired so that it is consistent with similar data from proton-treated patients in the PPCR. Data obtained will be used to compare outcomes in patients treated with proton versus photon therapy.

3.0 SCOPE

The Contractor shall obtain and monitor data acquisition and management by individual hospital centers where pediatric cancer patients have been treated with protons or photons in order to form a cohort of data from medical records. The Contractor shall maintain and manage a data platform that mirrors the platform used in the PPCR for acquisition and storage of de-identified proton and photon patient data, provide training and access to study staff at participating centers, and provide summary reports of data obtained for quality control purposes. The Contractor shall provide technical and informational assistance to individual centers to define, access, de-identify, and upload copies of required radiotherapy and imaging data, to be comparable to the proton radiotherapy and imaging data in the PPCR.

4.0 CONTRACT REQUIREMENTS

The Contractor shall perform the following tasks:

4.1 Coordinate and monitor data collection from existing medical records for eligible pediatric cancer patients treated with proton or photon therapy at participating hospital centers. This shall include orientation of staff at participating sites to the data requirements for the study and institution of procedures that will result in the systematic collection of de-identified medical and radiotherapy treatment data from existing medical records of eligible patients.

Orientation and monitoring activities will typically occur via email communication, teleconference or video conference, with travel to the participating centers considered on an as-needed basis to monitor study progress and data quality.

4.2 Assign unique study participant IDs to all eligible pediatric cancer patients treated with proton or photon therapy to facilitate creation of a cohort of data from medical records.

4.3 Monitor data collection progress through regular communication and occasional site visits on an as-needed basis with participating hospital centers.

4.4 Maintain a data acquisition and storage system to house de-identified data for a multi-center cohort of pediatric patients treated with protons or photons. Provide access and training to participating centers.

4.5 Maintain systems for data collection and transfer of de-identified radiotherapy plans, images and dose data. Provide access and training to participating centers.

4.6 Monitor data obtained from participating centers regularly for quality and completeness across all participating sites. Consult with study centers, if needed, to provide guidance and facilitate resolution of data quality issues or questions about collection of specific data elements. Provide NCI with quarterly progress reports to show progress of data collection and notify NCI of missing data fields or other data quality issues.

4.7 Consult with study centers, if needed, to review archived and current radiotherapy plans.

The Contractor shall provide guidance and technical support to participating centers to facilitate collection and de-identification of final radiotherapy plans at participating hospital sites. This work, to be performed by the participating sites, may include locating and unarchiving older radiotherapy plans. The Contractor shall provide support for centers to upload these plans for transfer to the Contractor’s system.

5.0 TYPE OF ORDER

This is a firm fixed price purchase order.

6.0 PERIOD OF PERFORMANCE

The period of performance is twelve (12) months from the effective date.

7.0 PLACE OF PERFORMANCE

Work shall be performed at the Contractor’s facility.

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall submit Quarterly Progress Reports describing the general progress of the work and any problems encountered. The Quarterly Progress Report shall also include a numerical summary of the number of proton and photon patients with deidentified data collected into the Contractor’s data collection system from each participating hospital or institution. The first quarterly report shall cover the first full three months of the contract, in addition to any fractional part of the initial month. Thereafter, reports shall be submitted on a quarterly basis.

Reports shall be due thirty (30) calendar days after the end of the reporting period. A fourth quarterly report will not be required for the period when an annual report or final report is due.

At the conclusion of data collection (due by 15 days before expiration date or as agreed upon by the Contractor and NCI), the Contractor will provide a data set to the NCI containing de-identified individual-level data for patients treated with protons or photons. The NCI shall review the deliverables submitted by the Contractor for acceptance within 14 days of receipt and approve the submitted reports. At the completion of the review, the NCI’s technical point of contact shall notify the Contractor as to the acceptability of the deliverable. If any changes or revisions are required of the Contractor, the revised deliverables shall be submitted to NCI within 5 days of the date of notification. If no comments or request for revisions are provided within 14 business days, the deliverables will be considered acceptable. In general, the NCI’s technical point of contact will provide technical scientific review and approval of all deliverables submitted by the Contractor.

All deliverables shall be sent electronically per the following schedule:

Table of deliverables – Pediatric Proton and Photon Therapy Comparison Cohort Coordinating

Center

Deliverable Description Due Date

#1 Quarterly

Progress

Report

Report shall include a brief qualitative description of the general progress of the work and any problems encountered, and also a numerical report of the number of proton and photon patients abstracted at each center to date.

Due within thirty

(30) days after three (3) months of performance

#2 Quarterly

Progress

Report

Report shall include a brief qualitative description of the general progress of the work and any problems encountered, and also a numerical report of the number of proton and photon patients abstracted at each center to date.

Due within thirty

(30) days after six

(6) months of performance

#3 Quarterly

Progress

Report

Report shall include a brief qualitative description of the general progress of the work and any problems encountered, and also a numerical report of the number of proton and photon patients abstracted at each center to date.

Due within thirty

(30) days after nine (9) months of performance

#4 Final Report Report shall include a summary description of the work performed and a numerical summary to include the total number of proton and photon patients abstracted at each center, overall and by calendar year of diagnosis and by type of cancer diagnosis.

15 days before expiration date.

#5 Final Data

Set

Data set containing de-identified individual-level data for patients treated with protons and photons.

15 days before expiration date.

9.0 Section 508 Accessibility Requirements

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998

(P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

Products, platforms and services delivered as part of this work statement that are ICT, or contain

ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 &

Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines.

All deliverable products provided shall be in compliance with Section 508 requirements.

Technical Criteria:

• E205.1 General - Electronic content shall comply with E205.

Functional Performance Criteria:

• 301.1 Scope - The requirements of Chapter 3 shall apply to ICT where required by 508

Chapter 2 (Scoping Requirements), 255 Chapter 2 (Scoping Requirements), and where otherwise referenced in any other chapter of the Revised 508 Standards or Revised 255

Guidelines.

• 302.1 Without Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that does not require user vision.

• 302.2 With Limited Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited vision.

• 302.3 Without Perception of Color - Where a visual mode of operation is provided, ICT shall provide at least one visual mode of operation that does not require user perception of color.

• 302.4 Without Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that does not require user hearing.

• 302.5 With Limited Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited hearing.

• 302.6 Without Speech - Where speech is used for input, control, or operation, ICT shall provide at least one mode of operation that does not require user speech.

• 302.7 With Limited Manipulation - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that does not require fine motor control or simultaneous manual operations.

• 302.8 With Limited Reach and Strength - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that is operable with limited reach and limited strength.

• 302.9 With Limited Language, Cognitive, and Learning Abilities - ICT shall provide features making its use by individuals with limited cognitive, language, and learning abilities simpler and easier.

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