Pilot study to evaluate follow-up methods for a prospective study of late effects in patients enrolled in the Pediatric Proton Consortium Registry.

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E1644, Bethesda, MD 20852, UNITED STATES. Description The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Radiation Epidemiology Branch (REB) plans to procure on a sole source basis services required to conduct a pilot study to evaluate follow-up methods for a prospective study of late effects in patients enrolled in the Pediatric Proton Consortium Registry from Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114-2696. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The North American Industry Classification System code is 541380 and the business size standard is $15.0M. Period of performance will be six (6) months from date of award. It has been determined that there is no opportunity to acquire green products or services under this contract. The research mission of the Radiation Epidemiology Branch (REB) is to identify, understand, and quantify the risk of cancer in populations exposed to medical, occupational, or environmental radiation, and to advance understanding of radiation carcinogenesis. The Pediatric Proton Consortium Registry (PPCR) was established in 2012 to focus on research into short and long-term outcomes of proton therapy. The PPCR currently registers and collects data from 1500 enrolled patients in nine participating centers in the US. All pediatric patients (<22 years of age) receiving proton radiation at participating centers are eligible for study. The coordinating center for the PPCR is the Massachusetts General Hospital. As the coordinating center for the PPCR, MGH is the only group that is collecting data from all 9 proton centers participating in the registry, and they are the only group that has sole access to the data that are collected from all nine centers. The data are captured via REDCap, a secure, web-based data collection platform with online survey capabilities. Currently, there are over 2000 potential data fields collecting information on demographics, diagnosis, baseline treatment and health details, as well as follow up health information. MGH is uniquely positioned to conduct a pilot study to evaluate the best methods for following proton-treated pediatric patients prospectively for up to 10 or more years after treatment at multiple hospital centers in the US, because they have sole access to the collected data from all 9 centers. Further, they have the contacts and relationships in place to conduct the pilot study required by the statement of work. OBJECTIVES and PURPOSE: The National Cancer Institute is proposing to conduct a pilot study to investigate the feasibility of methods for prospective follow-up of pediatric cancer patients who have received protons with the long-term goal of evaluating late effects such as second tumors and cardiac events. In order to be able to determine second cancer risk in pediatric patients treated with protons, the patients need to be prospectively followed over time at least up to 10 years after treatment. Both active (patient contact) and passive follow-up (linkage with the National Death Index) may be used to evaluate second cancer risk. Therefore, the National Cancer Institute propose to have the Contractor investigate the feasibility of active and passive approaches for patient follow-up. The Contractor shall describe approaches used at individual centers that are participating in the PPCR and determine the practicality and feasibility for active and passive follow-up of patients. This study will enable the National Cancer Institute to achieve a better understanding of the follow-up procedures currently used at these centers and possible future procedures. CONTRACTOR TASKS: The contractor shall: 1) Contact each participating PPCR center and document follow-up procedures of proton treated patients at each center. Prepare questions about follow-up procedures in collaboration with the National Cancer Institute. Administer questions about follow-up procedures of proton treated patients. 2) Prepare a report that includes the following topics: a. Summarize current follow-up procedures at each participating PPCR center and determine how effective they are at keeping track of patients. For example, how long do the centers keep in contact with patients and what percent of patients have been followed for more than 5 years? Once treatment is completed, describe who keeps in contact with the patients, for example, family physician, radiation oncologist, and/or medical oncologist, etc. b. Determine what Personal Health Information (PHI) is currently being collected by each center. c. Describe strategies currently used at the centers for maximizing long-term follow-up of pediatric proton patients by direct patient contact to obtain health outcomes. d. Evaluate the practicality of relying on patient self-reported outcomes of adverse events. What is the center's current experience with this method? e. Evaluate possible options for obtaining social security numbers and other PHI from individual centers in the PPCR to enable future electronic linkages with the National Death Index and the National Cancer Institute virtual pooled cancer registry. CONTRACTOR QUALIFICATIONS The Contractor shall have at least 3 years of experience collecting clinical data from pediatric cancer patients treated with protons from multiple treatment centers. The Contractor shall also have at least 5 years of experience in treating pediatric patients with proton radiation therapy, and provide consultation, advice, and guidance in the interpretation of the result of the pilot study. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The National Cancer Institute Technical Point of Contact, with input from the study Principal Investigator (PI), will be responsible for reviewing and approving all deliverables. The National Cancer Institute Technical Point of Contact shall provide the protocol to the Contractor prior to the beginning of the contract. The Contractor shall provide the following deliverables to the National Cancer Institute Technical Point of Contact, via email, in Microsoft Word format: DELIVERABLE NUMBER DELIVERABLE DESCRIPTION DUE DATE Base period (non-severable discrete work segment): Task 1 Work plan with project milestones and time line One month after award Task 2 Brief progress report describing contacts with collaborators at individual PPCR centers Three months after award Task 3 Draft written final report summarizing follow up procedures used at individual PPCR centers Five months after award Task 4 Written final report summarizing the contents Six months after award or end of contract GOVERNMENT RESPONSIBILITIES The government will furnish a list of questions to be asked of all of the participating proton treatment centers within two weeks of the award. The government will also review the draft final report and make recommended revisions. INSPECTION AND ACCEPTANCE CRITERIA The NCI Principal Investigator (PI) and technical point of contact shall review the deliverables submitted by the Contractor for acceptance within 30 days of receipt, to ensure consistency with the contract terms, and approve the submitted reports. At the completion of the review, the NCI and 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 the PI within 30 days of the date of notification. If no comments or request for revisions are provided within 30 business days, the deliverables will be considered acceptable. In general, the NCI PI will provide technical scientific review and approval of all deliverables submitted by the Contractor. This is not a solicitation for competitive quotations. However, if any interested parties, especially small businesses, believe they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. A copy of the capability statement must be received in the NCI Office of Acquisition on or before 5:00 PM EST on April 14, 2017. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Kathy Elliott, Contract Specialist at Elliottk@mail.nih.gov. A deter6mination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification on Sam.gov, www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02RC72541-61 on all correspondence.