Notice of Intent to Publish a Funding Opportunity Announcement for Scaling-up and Maintaining Evidence-based Interventions to Maximize Impact on Cancer (SUMMIT) - Tobacco Use Treatment for Cancer Survivors (UG3/UH3 Clinical Trial Required)
Notice Number:
NOT-CA-24-076

Key Dates

Release Date:
June 27, 2024
Estimated Publication Date of Notice of Funding Opportunity :
August 19, 2024
First Estimated Application Due Date:
November 15, 2024
Earliest Estimated Award Date:
July 01, 2025
Earliest Estimated Start Date:
July 01, 2025
Related Announcements

None

Issued by

National Cancer Institute (NCI)

Purpose

The National Cancer Institute (NCI) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications to the Scaling-up and Maintaining Evidence-based Interventions to Maximize Impact on Cancer (SUMMIT) Tobacco Use Treatment (TUT) initiative. Up to three (3) Research Projects are expected to be funded as part of SUMMIT TUT initiative.

Each Research Project will advance the science of scale-up and sustainment by testing strategies to increase and sustain the delivery of TUT services for cancer survivors.

The NOFO is expected to use the UG3/UH3 Exploratory/Developmental Cooperative Agreement activity code with the Clinical Trials Required designation. Awards made under this NOFO will initially support a two-year maximum milestone driven UG3 phase with a possible transition to a four-year maximum UH3 phase. During the UG3 phase, scale-up and sustainment strategies will be refined and preparatory activities for the scale-up and sustainment trial will occur. NCI will conduct an administrative review of UG3 milestones. Projects that do not complete UG3 milestones will not be approved to move forward to the UH3 phase. The scale-up and sustainment trial will be conducted during the UH3 phase.

The NOFO is expected to be published in late Summer 2024 with an expected application due date in late Fall 2024. Details of a pre-application webinar will be announced after the publication of the NOFO. This Notice is being provided to allow sufficient time for potential applicants with relevant expertise and insights to consider applying for this NOFO.

Potential applicants are encouraged to view the presentation of this initiative to the Joint Virtual Meeting of the NCI Board of Scientific Advisors and the National Cancer Advisory Board available at https://videocast.nih.gov/watch=54859 beginning at 3 hour, 57 minutes. Presentation slides are downloadable at https://deainfo.nci.nih.gov/advisory/joint/0624/Chambers.pdf.    

Research Initiative Details

Among adults ever diagnosed with any cancer, 12.2% report current smoking. Individuals with cancer who smoke are at an increased risk of cancer-related mortality, cancer recurrence, second primary cancers, decreased response to cancer treatments, and increased financial burden. Quitting smoking is one of the most effective ways to improve quality of life and overall health, and is associated with a 45% median increased survival rate.

Research has identified effective TUT services that support cessation from all tobacco products. Evidence-based cessation interventions include behavioral counseling, medication, and other types of support. However, rates of delivery of effective TUT services for cancer survivors are suboptimal. 

To meet the research goals of SUMMIT TUT, applications must include the following: 

  • Use of a randomized controlled trial design (e.g., parallel cluster randomized, stepped-wedge cluster randomized, and other types of randomized designs) to test strategies to scale-up and sustain the delivery of TUT services for cancer survivors; 
  • A minimum of 60 sites, for which a single site may include (but is not limited to) a primary care clinic, specialty care clinic, community cancer center, Federally Qualified Health Center clinic, and/or other contexts in which TUT services are provided for cancer survivors;
  • Measurement of the delivery of TUT services (offered and provided) at least 12 months after full implementation;
  • Use of validated measures;
  • Sites that are diverse in size, location, and resources;
  • Populations that are diverse in race, sex and gender identity, ethnicity, geography, and socioeconomic status; and
  • Populations experiencing health disparities and health inequities.
     

All applications must include a clinical trial to be responsive to this NOFO. Trials proposed must meet the NIH definition of a clinical trial (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html) and should contribute to the advancement of evidence-based medicine/practice and the sciences that support it.

Funding Information

Estimated Total Funding

Up to $2.4M for FY2025

Expected Number of Awards

3

Estimated Award Ceiling

$500k in direct costs per year for a maximum of two years for the UG3 phase

$850k in direct costs per year for a maximum of four years for UH3 phase

Primary Assistance Listing Number(s)

93.393; 93.399

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Wynne E. Norton, PhD
National Cancer Institute (NCI)
Division of Cancer Control and Population Sciences
Telephone: 240-276-6875
Email: wynne.norton@nih.gov

Cynthia A. Vinson, PhD, MPA
National Cancer Institute (NCI)
Division of Cancer Control and Population Sciences
Telephone: 240-276-6745
Email: cvinson@mail.nih.gov