# Creating an efficient clinical trial build system via the Clinical Trials Rapid Activation Consortium (CTRAC)

> **NIH NIH P30** · UNIVERSITY OF WISCONSIN-MADISON · 2021 · $150,000

## Abstract

ABSTRACT
Scientific Rationale. Childhood cancer survivors (CCS) represent a vulnerable population at high risk of
medical and psychosocial sequelae of cancer and cancer treatment necessitating survivorship care supported
by Children’s Oncology Group (COG) long-term follow-up guidelines. However, current data indicate that most
CCS are not receiving recommended survivorship care. To date, approaches to identify receipt of guideline-
concordant care fail to routinely include community and organizational factors that may influence receipt of this
care. There is a critical need to develop an approach to identify receipt of guideline-concordant care in real
time, incorporating CCS-generated and community and organizational-level data to explore disparities in care
and ultimately support future interventions targeting the sources of those disparities.
Hypothesis. We hypothesize that development of an electronic health record (EHR)-based CCS registry
supplemented with patient-generated data will (1) be feasible and acceptable to CCS, (2) provide actionable
identification of CCS not receiving guideline-concordant care, and (3) enable assessment of community and
organizational factors associated with receipt of guideline-concordant care.
Project Design. In Aim 1, our multi-disciplinary research team will draft CCS data elements to incorporate into
our existing EHR-based cancer registry system, Healthy Planet (Epic Systems™). We will emphasize data
elements that are not traditionally part of EHR-registries including community (e.g., neighborhood social
cohesion, Area Deprivation Index) and organization factors (e.g., availability/efficacy of pediatric-to-adult care
transition visits for CCS, barriers to survivorship care plan development or access). A CCS Advisory Board (n =
6-10 adult CCS or parents of CCS <18 years of age) will then review the proposed data elements over the
course of 2-3 Advisory Board meetings, driving iterative revision of registry elements. Aim 2 will recruit 30 adult
CCS from the EHR-based registry to input patient-generated data into the registry including self-reported
community-level data and patient perspectives on organizational-level factors. Feasibility will be assessed
through participation rate and data completeness. Acceptability of CCS-generated data will be assessed via
participant surveys. For Aim 3, we will compare assessments of guideline-concordant care between traditional
retrospective chart review and the new EHR-based registry. We will conduct exploratory analyses to assess
whether community and organizational factors explain disparities in receipt of guideline-concordant care.
Next Steps. Development of the proposed EHR-based registry is a necessary, first step toward the design of
cancer center-level interventions to eliminate disparities and improve CCS outcomes. Once sufficient data is
available, we will perform definitive analyses to identify community and organization factors related to receipt of
guideline-...

## Key facts

- **NIH application ID:** 10409009
- **Project number:** 3P30CA014520-47S5
- **Recipient organization:** UNIVERSITY OF WISCONSIN-MADISON
- **Principal Investigator:** HOWARD H. BAILEY
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $150,000
- **Award type:** 3
- **Project period:** 1997-04-25 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10409009

## Citation

> US National Institutes of Health, RePORTER application 10409009, Creating an efficient clinical trial build system via the Clinical Trials Rapid Activation Consortium (CTRAC) (3P30CA014520-47S5). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/10409009. Licensed CC0.

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