HDRP Newsletter, September 2022

Research Spotlight: Improving Rigor and Interpretability in Cluster Randomized Trials: An NCI Methods Short Course

Healthcare delivery research, improvement science, and implementation studies often use randomized controlled trial designs to evaluate the effects of healthcare delivery or implementation interventions on patient-level outcomes, as well as processes of care, care quality, healthcare utilization and implementation outcomes. In some circumstances, study designs that use individual-level randomization may be infeasible and can generate concerns about contamination between those randomized to receive the intervention and those randomized to the control or comparison arm of a study. To minimize these potential threats to internal validity, and to address some of the ethical, logistical, and cost considerations, a specific type of randomized controlled trial—the cluster randomized trial (CRT)—is often needed. In CRTs, the unit of randomization may be clinics, hospitals, community-based organizations, schools, worksites, or entire communities. These trial designs that randomize clusters are increasingly used in implementation science and healthcare delivery research.

As interest in this type of study design has expanded, so too has the need to provide resources to support investigators in conducting CRTs. To complement existing resources, including those available through the NIH Office of Disease Prevention, the NIH Research Methods Resources, and the NIH Pragmatic Trials Collaboratory, NCI recently sponsored a virtual short course.

This short course, Cluster Randomized Trial Designs in Cancer Care Delivery, was designed to continue to build methodologic expertise in the design and interpretation of CRTs. The course attracted more than 1,200 registrants and was held Tuesday, May 3 - May 5, 2022. We were very fortunate to have had two international experts serve as course faculty, Dr. Karla Hemming and Dr. Monica Taljaard. Through a series of lectures, the course provided training in the design, conduct, and analysis of CRTs, including parallel CRTs, stepped-wedge CRTs, and cluster randomized cross-over trials. Topics covered included the rationale for the use of these designs, sample size calculations, analytic methods, ethical considerations, and trial reporting and interpretation, among others. Principles were illustrated using case studies reflecting different CRT design variations, with examples drawn from across the cancer control continuum (prevention, diagnosis, treatment, survivorship, and at end-of-life).

Materials from this course will be available soon.

For more information regarding the Short Course, please see the event page and email Dr. Sandra Mitchell or Dr. Wynne Norton for additional information.

Research Spotlight: HDRP’s PROSPR Research Initiative and PROSPR DataShare

What is PROSPR?

PROSPR, or Population-based Research to Optimize the Screening Process, is a NCI-funded research network that includes 10 diverse healthcare delivery systems across the United States. The goal of PROSPR is to better understand how to improve the cancer screening process (recruitment, screening, diagnosis, referral for treatment) in community healthcare settings in the United States. PROSPR is conducting multilevel observational research to evaluate factors that affect the quality and outcomes of the screening processes for cervical, colorectal, and lung cancer. Each PROSPR Research Center (PRC) conducts organ-specific research and participates with other PRCs to conduct trans-PROSPR research projects. PROSPR is currently in its second funding cycle, which runs through 2024. Learn more about PROSPR on our website.

Introducing PROSPR DataShare

The PROSPR Team has developed PROSPR Data Share (PDS), a web-based system that facilitates sharing of PROSPR data with external (non-PROSPR) researchers.

PDS can be used to request PROSPR public use data sets, which are static HIPAA-defined deidentified data sets. These data sets are intended to introduce researchers to the type of cancer screening data PROSPR collects, and include data elements that describe the cancer screening process (screening examination, diagnostic evaluation, and diagnosis) at the individual level. There is no charge for receipt of these data sets.

PDS also can be used to request custom-made HIPAA-defined limited data sets. These data sets are created on a case-by-case basis from the PROSPR data repository, which has hundreds of data elements. Most provide individual-level characteristics and information on the cancer screening process. Other data elements provide information of interest to health services researchers, such as type of health care system. To see the totality of data elements, please visit the PROSPR DataShare homepage and click on PROSPR Restricted Use Data Dictionaries. Please note that requests undergo a multi-step review process, and as such, applicants should expect 3-4 months for an answer. In most instances, there is no fee for this type of data set.

Researchers who wish to propose ancillary studies – primary data collection projects that use PROSPR infrastructure and resources – can use PDS to submit their idea. Funding to carry out an ancillary study must be provided by the external researcher. All ancillary studies require involvement of at least one PROSPR investigator.

Interesting in learning more about PDS?

On September 20, 2022, HDRP held the Population-based Research to Optimize the Screening Process (PROSPR) Initiative: Research Activities and Data Sharing webinar, which provided an overview of PROSPR, PDS, and the PDS request and approval procedures. The webinar recording and materials will be available soon.

To learn more about PROSPR and PDS, please contact us!

Announcements

NCI Re-issues Announcement for Outstanding Investigator Award Revised to Encourage a Broader Pool of Investigators

NCI recently re-issued the announcement for the Outstanding Investigator Award program (Outstanding Investigator Award [OIA] R35 RFA). The purpose of the OIA is to enable more flexibility for investigators with outstanding research accomplishments in all areas of cancer research to pursue new or high-risk areas by providing 7 years of support. This program has been highly successful in promoting innovation among its recipients.

One of the requirements of the OIA is that candidates must be nominated by their institution. Although applicants only need to have been a principal investigator on an eligible NCI grant for the past 5 federal fiscal years, few of the applicants are mid-career, women, or underrepresented minorities. In this re-issuance, changes were made to the terms of the award to enable greater flexibility for applicants with other existing NCI awards.

We encourage nominations from a broader pool of investigators than in the past. If you have previously considered this award, please take a fresh look at the opportunity.

For further information on the OIA, complete eligibility criteria, and receipt dates, please visit the OIA website.

Program Contact for the OIA: Christine Siemon.

Policy Updates

NIH Expanding Usage of Notices of Special Interest (NOT-OD-19-107)

This notice informs the extramural community that NIH is expanding and formalizing the use of notices of special interest (NOSI) posted in the NIH Guide for Grants and Contracts to announce interest in specific scientific research topics.

How Does a NOSI Work?

A NOSI is a standard, formal format for NIH institutes to share and update their research priorities. A NOSI describes specific topics of interest and will direct applicants to one or more active notice of funding opportunities (NOFOs) for application submission. A NOSI is not a NOFO and is listed as a notice in the NIH Guide for Grants and Contracts. Applicants should read NOSIs carefully for any special requirements related to that specific announcement.

For more information about NOSIs sponsored by HDRP, visit the funding opportunities page of our website and read more in our Funding Opportunities section of this newsletter.

Requests for Applications (RFAs)

This section includes new RFAs for healthcare delivery research since the last edition of this newsletter. For a complete list of funding opportunities, visit our funding opportunities webpage.

Research to Understand and Address the Survivorship Needs of Individuals Living with Advanced Cancer (R01) RFA-CA-22-027

Contact: Michelle Mollica
Expiration Date: September 30, 2023

HDRP Funding Announcements

This section includes links to new NOFOs for healthcare delivery research published since the last edition of this newsletter. For a complete list of NOFOs, visit our funding opportunities webpage.

Funding Opportunities

Time-Sensitive Opportunities for Health Research (R61/R33 Clinical Trial Not Allowed), PAR-22-233

Contact: Sallie Weaver
Expiration Date: November 2, 2023

Patient-Clinician Relationship: Improving Health Outcomes in Populations that Experience Health Care Disparities (R01), PAR-22-064

Contact: Sallie Weaver
Expiration Date: January 8, 2025

Notices of Special Interest (NOSI)

Notice of Special Interest (NOSI): Addressing Cancer-Related Financial Hardship to Improve Patient Outcomes, NOT-CA-22-045

Contact: Kate Castro
Expiration Date: March 1, 2024

Notice of Special Interest (NOSI): Disparities Affecting Healthcare Utilization and Health Outcomes Among Childhood Cancer Survivors, NOT-CA-22-029

Contact: Veronica Chollette
Expiration Date: October 9, 2024

For more information about funding including additional notice of funding opportunities, please visit our website.

HDRP Upcoming Webinars/Workshops

Challenges and Opportunities for Addressing Financial Hardship as Part of Cancer Care Delivery

On October 6, from 12pm – 4:30pm ET, NCI will host Challenges and Opportunities for Addressing Financial Hardship as Part of Cancer Care Delivery. In 2020, the National Cancer Institute (NCI) awarded administrative supplements to 11 NCI-Designated Cancer Centers to conduct research to develop or expand their capacity and infrastructure to deliver financial navigation services to cancer patients and their families. The goal of this workshop is to convene investigators from the funded teams to share findings from their studies and to stimulate conversation about the challenges and opportunities for research to address cancer-related financial hardship.

NCI/AcademyHealth Healthcare Delivery Research Scholars Program -New Webinar: Healthcare Delivery Research and Opportunities in Older Adults with Cancer

On October 11, from 12pm – 1:00pm ET, the 2021-2022 NCI/AcademyHealth Healthcare Delivery Research Visiting Scholar Program, Dr. Virginia Sun, Ph.D., R.N., from City of Hope, will present findings from her project on NIH-funded studies focused on cancer and aging. This study aims to describe the currently active NIH/NCI-funded research grant portfolio that targets the care of older adults with cancer and their family caregivers across the cancer continuum, as well as develop and disseminate a health care delivery research framework for older adults with cancer.

Interdisciplinary Teams Addressing Social Risks in Cancer Care

This series will highlight important topics related to implementing interdisciplinary care team models and approaches for addressing social risks and needs of cancer patients and survivors across diverse care delivery settings. The National Academies of Sciences, Engineering, and Medicine report Integrating Social Care into the Delivery of Health Care described five systems-level activities – Awareness, Adjustment, Assistance, Alignment, Advocacy – that healthcare organizations and healthcare teams can conduct to strengthen the integration of social care into clinical care. The report also identified key components for conducting these five activities, including appropriately staffed and trained interprofessional teams working together to address social conditions and provide efficient clinical care.

This series will discuss existing interdisciplinary care workforce models for addressing social risks in cancer care, challenges for interdisciplinary care teams and healthcare organizations, and opportunities for value-based approaches aimed at improving the delivery of high-quality clinical and non-clinical care for cancer patients.

To view recordings of the previous webinars or register for the final webinar in this series, visit our webinar series webpage:

• Date coming soon! - Addressing Social Risks During Active Treatment and Survivorship: An Interdisciplinary Teams Perspective (Case Study #2)

Addressing Social Risks in Cancer Care Delivery Webinar Series

This webinar series builds on the Addressing Social Risks in Cancer Care Delivery Workshop and explores important research topics related to improving equity in the delivery of cancer care for diverse cancer populations and communities. Webinar presentations and discussions will highlight innovative research approaches for social risk screening in cancer care delivery settings, interventions that inform clinical care for cancer patients and survivors experiencing social risks, models for connecting cancer patients and/or caregivers with social care resources, and creating clinical-community partnerships to increase availability and accessibility of social care resources.

Register here for these webinar dates:

• Coming in 2023! A Decade of Social Risk Research in Cancer: A systematic review of the literature on food insecurity, housing instability, and transportation barriers among cancer patients and survivors

For other upcoming events please check our website. Events are updated regularly. To view our archived events, visit our Events webpage.

HDRP Webinars/Workshops Recap

Machine Learning and Health Outcomes in Cancer Care Delivery Research

On May 16-17, 2022, HDRP hosted a virtual workshop that focused on research in machine learning, cancer care delivery, and health outcomes. The goals of this workshop were to identify scientific gaps, barriers, and opportunities in this emerging area of cancer-focused healthcare research. A meeting recording is available online on the NCI event page and a meeting report will be available soon.

Cancer Caregiving Webinar Series

In 2022, HDRP hosted a five-part webinar series on cancer caregiving. The webinar series invited NCI-funded grantees to describe their accomplishments, challenges, and next steps in cancer caregiving research. The final webinar of this five-part webinar series was held on May 18, 2022, and featured a conversation with NCI on the themes identified among the funded grants and key opportunities for future research on informal cancer caregiving. This webinar began with a review of a cancer caregiving portfolio and opportunities to submit future caregiving funding applications and ended with an open discussion with Drs. Ashley Wilder Smith and Michelle Mollica about themes and lessons learned throughout this webinar series. To watch the recordings of the webinar series, visit the webinar series webpage.

For information and archived recordings of HDRP’s previous events, visit our Events page.

Data and Resources

This section features information about a select number of HDRP’s data resources. A complete list of HDRP’s data and resources is available on our Data & Tools webpage.

SEER Linkages

• SEER-CAHPS: There have been several recent publications using the SEER-CAHPS data resource. View the SEER-CAHPS website to review publications.
• SEER-MHOS: SEER-MHOS, a cancer health outcomes data resource, recently released a newsletter. View the latest SEER-MHOS newsletter (PDF, 191 KB).

To learn more about the SEER linkages, visit SEER-Medicare, SEER-Medicaid, SEER-CAHPS, and SEER-MHOS.

National Health Interview Survey

NHIS 2021 data are available at the National Center for Health Statistics website. These data include colorectal, breast, prostate, and cervical cancer screening, as well as several questions on COVID-related delays in cancer care.

HDRP Employment and Training Opportunities

HDRP is excited to announce that we are recruiting for the following employment opportunity:

• Cancer Research Training Award, Healthcare Assessment Research Branch: This fellowship opportunity includes functioning as a member of the branch and work on projects directly related to HARB and other HDRP research priorities. A particular focus of this position will be development and evaluation of new data linkages, for example enhancements to SEER-Medicare and SEER-Medicaid, as well as novel linkages between SEER and other sources of data, especially those focused on economic factors. The successful applicant will have opportunities to collaborate on analyses and manuscripts, including leading their own research projects under the mentorship of NCI scientists. Day-to-day activities may include literature reviews, development of research plans, data abstraction, data analysis, dissemination activities (scientific abstracts, presentations, and manuscript preparation), portfolio analysis, and support of other branch research initiatives as needed.

Visit the Employment and Training webpage to learn more about HDRP Employment and Training opportunities.