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Title: Development and Validation of Patient Reported Outcome (PRO) Measures for individuals with Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs) Document Type: Combined Synopsis / Solici... Title: Development and Validation of Patient Reported Outcome (PRO) Measures for individuals with Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs) Document Type: Combined Synopsis / Solicitation Notice Solicitation Number: 75N91022Q00061 Proposed Posted Date: 4/27/2022 Proposed Response Date: 5/4/2022 Classification Code: DE02 - IT and Telecom - Mobile Device Support Services (labor) NAICS Code: 519190 – All Other Information Services Business Size Standard: $27.5 million Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E122, Bethesda, MD 20892, UNITED STATES. Non-USPS mail such as Fedex UPS and other private carriers please use Rockville, MD 20850. The National Cancer Institute (NCI), Center for Cancer Research (CCR), Pediatric Oncology Branch (POB), Office of Acquisitions (OA) would like to procure services to enable the design of PAINS-pNF and PII-pNF measures to be administered via a mobile application or web-based platform. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. 75N91022Q00061 includes all applicable provisions and clauses in effect through FAR FAC 2022-04 (JAN 2022) simplified procedures for commercial items. The North American Industry Classification System code is 519190 and the business size standard is $27.5 million. Only one award will be made as a result of this solicitation. This will be awarded as a non-severable firm fixed price type contract. BACKGROUND Neurofibromatosis 1 (NF1) is a genetic disease with multiple clinical manifestations, including plexiform neurofibromas (pNF) that can cause pain and may significantly impact daily functioning and quality of life (QOL). Patient-reported outcomes (PROs) are useful in trials for conditions that are disabling and chronic like NF1, where symptom reduction and improved functioning and QOL currently are important treatment outcomes, which may occur with pNF shrinkage. A critical step toward approval of drugs to treat pNFs is to evaluate clinical benefit in conjunction with a reduction in tumor volume as assessed by imaging endpoints. Currently, no valid PRO measures exist that are specific to the NF1 population to assess pNF pain or its functional impact on an individual’s life. The Pediatric Oncology Branch (POB), Health Psychology and Neurobehavioral Research Program has conducted extensive qualitative research to modify existing pain interference and pain intensity PRO measures to ensure they accurately capture patients’ pNF-related pain experiences. The next phase of the study involves evaluating the final electronic versions of these new PRO measures on reliability, validity, sensitivity to change, and feasibility in individuals with NF1 and pNFs. The measure assessing pain intensity (PAIN-pNF) will be administered every evening for two consecutive weeks (it takes about 1-2 minutes to complete) and the measure assessing pain interference (PII-pNF) will be administered at the end of the week (it takes about 5 minutes to complete) for two consecutive weeks. Administration will occur in participants’ homes over the past 24 hours to ensure real-time assessments of pain in their natural environments. POB is seeking this acquisition to develop a mobile application (app) to be able to administer these PRO pain measures easily to youth and adults from the comfort of their homes for this validation study. Once the measures are validated, this platform will be used to administer the measures in clinical trials evaluating therapies to treat plexiform neurofibromas. Based on qualitative research results from extensive patient input, the two pain measures must look and function exactly like those POB used in cognitive debriefing interviews and must be able to fit and be useable on a range of devices including computers, tablets, and smartphones. Further, the location of the physician-selected pNF target tumor area must be able to be circled on a body figure, which is re-populated at each evaluation in a clinical trial. The National Cancer Institute (NCI) supports projects to develop and evaluate PROs in order to assess participants’ experiences and clinical outcomes more accurately. Both of the PRO measures have been accepted into the rigorous FDA Clinical Outcome Assessment program and will be reviewed as potential new clinical outcome assessments for pNF-related pain. OBJECTIVE The primary purpose of this acquisition is to design the PAINS-pNF and PII-pNF measures to be administered via a mobile application or web-based platform to conduct the second phase of POB’s study which consists of evaluating the final electronic versions of these two pain PRO measures on reliability, validity, and feasibility in individuals with NF1 and pNFs ages 8 years and older. These pain PRO measures need to be administered in participants’ homes daily for two weeks to ensure real-time assessments of pain in their natural environments. Thus, POB will work with the Contractor to develop a mobile application (app) to: (1) Be able to administer these PRO pain measures easily to youth and adults from the comfort of their homes via a web-based platform or via mobile phone; (2) Have the measures exactly like POB had developed them using patient input; and (3) Be able to have questionnaires work on a range of devices including computers, tablets, and smartphones. Developing and administering these PRO measures at home using the app or web-based platforms will allow POB to validate these measures to assess tumor pain and pain intensity in children through adults with pNF for use in clinical trials. These would be the first measures specifically developed to assess NF-related pain which are sorely needed to document changes associated with new treatments being evaluated in clinical trials being done in collaboration with the POB, NCI. SCOPE POB needs a mobile software platform that is able to facilitate data collection in a private and confidential way in participants’ homes via their own smartphone devices or via web links. The mobile or web application must enable research participants to complete electronic versions of the pain intensity measures in their homes daily and other measures (e.g., pain interference measures) weekly. POB also requires the software platform to provide a researcher portal through which the research team will have access participants’ dashboards to indicate data completion. The Contractor’s development team will provide training on the administration of these questionnaires as well as to be available to troubleshoot any technical problems as needed during the study. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS The personnel qualifications, specific tasks and services required of the contractor, and submission requirements for this project are described below. Personnel Qualifications: Previous experience collecting electronic PRO data and conducting remote research studies as evidenced by study results published in numerous refereed journals and applications for ePRO data collection previously used by at least 100 researchers. Previous experience developing custom electronic PRO measures, conducting validation studies and supporting technology requirements for multi-site clinical trials as evidenced by portfolio projects. Experience providing similar services to NCI and other NIH branches. Project personnel must have all the following: 1) At least a Master’s degree, five or more years of experience developing mobile and web applications for remote clinical research, 2) expertise supporting multi-site clinical trials, including providing site staff training and technical support, and 3) a deep understanding of data privacy & security practices for remote data collection. Measures Development and Requirements: The Contractor shall develop an overall plan for incorporating the study and validation PRO measures within its platform. The two electronic study PRO measures (PAINS-pNF and PII-pNF) should be developed to look as close as possible to the screenshots below (see section 4.5.1). The target tumor area needs to be able to be drawn on the human figure for each patient and then populate for each of his/her pain assessments to be completed throughout the duration of the study period. These electronic PROs should be able to facilitate data collection in a private, secure, and confidential way in participants’ homes via their own smartphone devices or via web links. The timing/delivery of the electronic PRO measures should be tailored based on individual patient and parent schedules and measures. Once delivered, electronic PROs should be available for patients to complete within a given timeframe (e.g. 2 hours) and include automated reminders across multiple channels (email, SMS, push notifications) to facilitate completion. Patients should be able to view their completion rates for all study measures throughout the duration of the study. Platform should include additional capabilities to provide content to patients (e.g. Study Contacts, Help Guides, etc.) and facilitate secure communications with Site Staff and Research team. Clinical Site Staff Application Requirements: Set up a secure password-protected portal, through which Site Staff can access and manage all study related functions including: 1) Patient enrollment and customization of electronic PROs measures and assessment schedules for individual patients and their parents; 2) viewing patient dashboards indicating completion rates, real-time safety or compliance related alerts, and secure communications; and 3) managing Site Staff access and permission levels. Provide training materials to site staff to facilitate study execution. Have a customer service team to provide ongoing support during the study should any technical difficulties arise that require software support. Research Team Portal Requirements: Set up a secure password-protected researcher portal, through which the research team will have access to all protocol materials. Research portal must include tools for managing electronic PRO measures including customizing content, delivery, and reminder schedules. Research portal must be flexible enough to include measures not defined in this SOW from sources such as the PROMIS database. Research portal must include real-time monitoring tools for patient compliance and safety. Research portal must include tools for creating and managing clinical sites including site staff permissions. These permissions must be different for the NCI site and participating sites, whereby the NCI team will have permissions to view data collection across sites. All study data collected should be available in real-time and downloadable at any time. Have a customer service team to provide ongoing support should any technical difficulties arise that require software support. Submission requirements: Please submit mock-ups of the Patient experience demonstrating the two different electronic PRO measures (PAINS-pNF and PII-pNF) to fit on a smartphone screen (see screenshots below). Please submit mock-ups of the Site Staff experience demonstrating patient enrollment and monitoring. Please submit mock-ups of the Research Team experience demonstrating study configuration and sample data outputs. 1.6 Timeline requirements: 1.6.1 Solution requirements must be field ready to administer to study participants no later than 30 days after the award of this project. TYPE OF ORDER This shall be issued as a Non-Severable Firm Fixed-Price Purchase Order. PERIOD OF PERFORMANCE The period of performance shall be from May 15, 2022 to May 14, 2023. PLACE OF PERFORMANCE Pediatric Oncology Branch (POB), Behavioral Health Core Health Psychology and Neurobehavioral Research Program National Cancer Institute, National Institutes of Health Address: Center for Cancer Research, National Cancer Institute Building 82, Room 105 9030 Old Georgetown Rd Bethesda, MD 20896-8200 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE Complete deliverables for listed below. All deliverable products (measures within the application and researcher portals) shall be submitted for review and comment to Technical Point of Contact (TPOC) per the following deliverable schedule: DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE #1 Develop and incorporate all study and validation measures, including the study measures (PAINS-pNF, PII-pNF) and validation measure (e.g., eCAS), within the platform 30 days after award #2 Set up the secure data collection platform to be used across all participating sites and to be nested within the NCI 30 days after award #3 Provide a training for all sites on the download, administration, and tracking compliance of participant’s responses via the Contractor’s system 30 days after award #4 Provide troubleshooting and customer service support for any difficulties that may arise with the application