Rationale: UCSF and the Benioff Children's Hospital have been selected by the national Children's Oncology Group Consortium (COG) of the National Cancer Institute (NCI) to conduct new Phase I Pediatric Oncology studies. Patients enrolled in these studies who are not admitted to the Pediatric Clinical Research Center (PCRC) Inpatient Unit, will require evening and weekend support for study procedures, including timed blood draws, sample processing and EKGs. We propose a “Mobile Study Support” (MSS) Pilot, under the CTSI/Clinical Research Services-PCRC to improve the conduct of translational research. MSS services would assist in providing research procedural care to oncology inpatients participating in clinical trials on the 7-Long Oncology Floor, as well as other UCSF investigator studies. We anticipate the MSS model will become widely utilized as we transition to our new pediatric hospital at Mission Bay.

Plan: A PCRC research nurse, 60% FTE, will become an Administrative Nurse (AN) I and will increase her effort to 90%, to include MSS nursing, PCRC outpatient unit clinical care, and administrative duties. The nurse in this position will be familiar with related study procedures, since procedures for Oncology protocols to be supported, mirror the 70 current active research studies in the CTSI/CRS-PCRC. Immediate benefits of this pilot are continuity with knowledge of investigator studies and teams, clinical research nursing expertise to these teams, and expert care to patients participating in these phase I trials. The new AN I position of the MSS PIlot is an innovative role that will add value to the growing demand for pediatric Outpatient and mobile visits. Because this position contains an administrative component, the hours will be flexible to meet the demands of the clinical care and administrative needs without requiring to pay for on call time for mobile visits. The MSS pilot design will dedicate maximal effort to protocols approved under the COG Consortium while accommodating variability in protocol volume as this new service line grows. Sustainability will be measured by the increase in investigators supported and the expansion of site locations beyond the Benioff oncology unit on 7 Long. (see collaborators below). Six active Oncology studies are requesting immediate support: ADVL0912, ADVL1112, ADVL1013, ADVL1011, ADVL0921, NANT0702. Three additional, new leukemia phase 1 studies in various stages of development are also strong candidates: AALL1121, ADVL1114, TACL0903.

Criteria and metrics for success: Measures of success will include number of studies, number of patient locations, number of patients served, patient contact hours, investigator satisfaction with nursing and study support, and cost per patient vs. alternative costs (such as admission to PCRC beds). Challenges and barriers to success will be presented to the CTSI CRS leadership to improve the pilot design. Funding contributions to support this pilot will be sought from investigator grants to ensure the pilot's success and sustainability. Alignment with CTSI Strategic Goals includes responsiveness to; 1) "CRS-without-walls" model to increasingly support investigators outside the current eight CRS sites, 2) Creating cross-cutting initiatives with consortium partners, thus increasing new and potential collaborations to accelerate research, 3) Work with CTSI's Program Evaluation Unit to apply dashboard/metrics methods to monitor and report on progress. This MSS Pilot can also serve as a model for the national COG-NCI group, other CTSA sites, and is in alignment with the model of the National Center for Advancing Translational Sciences (NCATS/NIH).

Cost and sustainability: Administrative Nurse I salary and benefits at 60% are as follows:

$147,394 (salary base) x 60% (effort) = $88,438 (salary) + $20,438 (benefits) = $108,876. $100K is requested for this pilot. After initial start-up cost, cost recovery is anticipated for services to offset 20-30% costs in YR1, with further increases in out years. As MSS demand increases, service providers other than RNs may be included to perform research procedures not requiring RNs, such as performing EKGs and processing specimens during non-business hours.

Collaborators: NCI Children’s Oncology Group (UCSF investigators Drs. Kate Matthay, Steven DuBois, Robert Goldsby, and others), UCSF Intensive Care Unit Research Team, UCSF Cancer Center, UCSF Benioff Children’s Hospital at Mission Bay.