Outreach Project for Cancer Clinical Trials

Overseen By The Ohio State Comprehensive Cancer Center

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a program called CUSP2CT can increase participation in cancer clinical trials among racial and ethnic minorities. The project aims to understand and overcome barriers that prevent these groups from joining trials, which is crucial for improving cancer prevention and treatment. Participants may engage in interviews and educational activities to identify and address these barriers. The trial seeks individuals within the Ohio State University cancer network, particularly in specific counties or clinics involved in the study. As an unphased trial, this study offers a unique opportunity to contribute to research that seeks to make cancer treatment more inclusive and effective for everyone.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CUSP2CT project is safe?

Research has shown that the CUSP2CT project aims to increase clinical trial participation among underrepresented racial and ethnic groups. Although specific safety data for CUSP2CT is unavailable, the project centers on educational and community outreach activities, not medical treatments, ensuring no direct health risks.

The project includes interviews, discussions, and educational sessions with community members and healthcare providers. These activities are safe and easy to participate in, as they do not involve medication or medical procedures.

In summary, because CUSP2CT does not involve drugs or invasive procedures, it is considered safe for participants. The main goal is to enhance community engagement and awareness about clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CUSP2CT Project because it aims to tackle the persistent barriers to participation in cancer clinical trials, especially for racial and ethnic minorities. Unlike traditional approaches that often overlook these challenges, this project uses a combination of interviews, educational activities, and the Accrual Enhancement Program (AEP) to develop culturally tailored strategies. By actively involving community members, providers, and clinic staff in the design and implementation of solutions, CUSP2CT hopes to boost trial participation and ensure more inclusive and representative cancer research.

What evidence suggests that the CUSP2CT project could be effective in increasing clinical trial participation among racial/ethnic minorities?

Research has shown that the CUSP2CT project, which participants in this trial will engage with, aims to increase the participation of racial and ethnic minorities in cancer clinical trials. This project focuses on removing obstacles that prevent minority communities from joining trials. It employs methods such as involving community health educators to connect these communities with healthcare providers. Participants in various phases of this trial will engage in interviews, discussions, and educational activities to explore and address current barriers to referral and participation. While the project's potential appears promising, its effectiveness in increasing trial enrollment is still under evaluation. ^{1 2 3 5 6}

Who Is on the Research Team?

Electra D. Paskett, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for racial and ethnic minority groups who are underrepresented in clinical trials, particularly those related to blood cancers, cancer in general, and tumors. The goal is to increase their participation in these important studies.

Inclusion Criteria

Phase I: 9 counties in the OSUCCC catchment area

Phase II: Patients, providers, and hospital systems/referral centers that directly addresses challenges identified in Phase I

Phase II: The project will involve the OSUCCC, the OSU James Cancer Network sites and the Columbus and Dayton NCORP sites

Timeline for a Trial Participant

Development

Community members, clinic staff, and providers undergo in-depth interviews for intervention development. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials. Providers, clinical staff, and research team participate in implementation discussions. Accrual enhancement program (AEP) strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions.

12 months

Implementation

Participants engage in the AEP in the remaining clinics at OSUCCC/James and community clinics. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation.

36 months

Evaluation

Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation.

12 months

Follow-up

Participants are monitored for the impact of the intervention on referral and accrual to clinical trials.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• CUSP2CT Project

Trial Overview

The CUSP2CT project at Ohio State University is being tested for its effectiveness in increasing referrals and enrollments of underrepresented minorities into cancer-related clinical trials through interviews, surveys, discussions, educational activities, and improving the accrual process.

How Is the Trial Designed?

Group I: Phase III (interview) Experimental Treatment 1 Intervention

Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5)

Group II: Phase II (AEP, education, interviews) Experimental Treatment 4 Interventions

Participants participate in the AEP in the remaining clinics at OSUCCC/James and community clinics on study. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation on study. (Years 2-4)

Group III: Phase I (interview, discussion, review, AEP, education) Experimental Treatment 6 Interventions

Community members, clinic staff, and providers undergo in-depth interview for intervention development on study. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials in each clinic site. Providers, clinical staff, and research team participate in implementation discussion. AEP strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions on study. (Year 1)

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a review of 585 oncology clinical trials, 46% required interventions, highlighting a significant gap in the accuracy of trial documents that could impact patient safety.

Among the 1001 interventions identified, 17.1% were classified as potential patient safety interventions (PPSIs), primarily related to medication, indicating the need for centralized review teams to enhance safety during trial implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation. Loo, VC., Kim, S., Johnson, LM., et al.[2023]

A workshop involving various stakeholders identified significant challenges in attributing adverse events (AEs) in oncology trials, including the complexity of the current 5-tier attribution system and inconsistencies in reporting.

Recommendations were made to simplify the attribution process by transitioning to a 2-3 tier system, improving baseline patient assessments, and enhancing training for investigators, which could lead to more reliable and efficient AE attribution in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving attribution of adverse events in oncology clinical trials. George, GC., Barata, PC., Campbell, A., et al.[2019]

The over-reporting of serious adverse events (SAEs) during clinical trials can obscure true safety signals and burden sponsors, investigators, and FDA reviewers, potentially endangering patient safety.

A working group from LUNGevity Foundation suggests that 'anticipated' SAEs related to lung cancer should not be reported individually to the FDA, but rather analyzed in aggregate, which could streamline reporting and improve safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer. Bonomi, P., Stuccio, N., Delgra, CJ., et al.[2021]

A novel video training program significantly improved knowledge and communication skills regarding cancer clinical trials (CCTs) among 192 blood cancer patients and caregivers, with notable increases in confidence and intention to discuss CCTs with healthcare providers (p < 0.001).

The training had a particularly strong impact on females who had never previously discussed CCTs with their providers and on patients aged 65 and older, indicating that targeted educational interventions can effectively empower underrepresented groups in cancer treatment discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing Patients to Communicate with Their Doctors About Clinical Trials as a Treatment Option: Impact of a Novel Video Intervention for Patients with a Blood Cancer and Their Caregivers. Vasquez, TS., Eggly, S., Sae-Hau, M., et al.[2023]

A training program for 101 healthcare professionals significantly improved their communication skills regarding randomized clinical trials, with key behaviors like explaining randomization and checking patient understanding showing marked increases after the intervention.

Participants reported a significant boost in self-confidence in discussing clinical trials, and actor patients rated their communication as improved in 12 out of 15 key areas, indicating the training's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme. Jenkins, V., Fallowfield, L., Solis-Trapala, I., et al.[2022]

A pilot program aimed at increasing awareness and participation in cancer clinical trials (CCTs) effectively improved knowledge among community leaders and primary care providers, leading to more patient inquiries about local trials.

The program also enhanced cultural competency among clinical researchers, which is crucial for recruiting and retaining diverse participants, particularly from minority groups, in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"The promise of community-based advocacy and education efforts for increasing cancer clinical trials accrual". Michaels, M., Weiss, ES., Guidry, JA., et al.[2022]

A survey of 727 stakeholders in cancer clinical research revealed that 93% believe patient-reported outcomes (PROs) for adverse events would enhance understanding of patient experiences during treatment.

The majority of respondents (88%) felt that using the PRO-CTCAE would improve the quality and efficiency of symptom data collection, indicating strong support for its implementation in clinical trials to inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Bruner, DW., Hanisch, LJ., Reeve, BB., et al.[2022]

A review of 209 lung cancer phase I and II trials presented at the American Society for Clinical Oncology meetings from 2017 to 2019 revealed significant variability in how adverse events (AEs) were reported, with six different thresholds for reporting AEs of any grade.

Treatment-related AEs were reported twice as often as treatment-emergent AEs, and there was a lack of clear definitions for critical terms like dose-limiting toxicity and serious AEs, highlighting the need for standardized reporting methods to improve data comparability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. Simons, EA., Smith, DE., Gao, D., et al.[2021]

In a study of 891 new cancer patients at a community cancer care center, only 9% were enrolled in clinical trials, primarily due to a lack of relevant protocols or restrictive inclusion criteria.

Despite low overall enrollment, the participation rate was about three times higher than national averages, and targeted patient navigation programs helped increase enrollment among American Indian patients to 10%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involving American Indians and medically underserved rural populations in cancer clinical trials. Guadagnolo, BA., Petereit, DG., Helbig, P., et al.[2022]

A pilot study involving 125 African American participants showed that community-centered education modules significantly improved awareness and attitudes towards cancer clinical trials (CCTs), particularly through interactive formats like call and response and role play.

Despite efforts to enhance participation rates in clinical trials among African Americans, the study highlights the need for tailored educational strategies, as traditional methods like workshops were less effective in changing perceptions about CCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a community-partnered cancer clinical trials pilot intervention with African American communities. Green, MA., Michaels, M., Blakeney, N., et al.[2022]

The clinical trial navigation service increased patient awareness of available cancer trials, but this did not translate into higher enrollment rates due to timing issues, as many patients learned about trials only after starting treatment, which often disqualified them.

The study highlighted the importance of physician involvement in discussing clinical trial options with patients early in their treatment process, as well as the need for more comprehensive and accurate trial listings in government databases to improve accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statewide cancer clinical trial navigation service. Moffitt, K., Brogan, F., Brown, C., et al.[2022]

A study of 118 patient advocacy organization websites revealed that while 81% provided links to ClinicalTrials.gov and 73% had their own clinical trial finders, only 23% mentioned expanded access (EA) programs for investigational treatments.

The limited information on non-trial pre-approval access pathways, such as the FDA's EA program and the right to try law, indicates a significant gap in resources available to patients seeking investigational treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient advocacy organizations' information for patients on pre-approval access to investigational treatments. Folkers, KM., Leone, S., Caplan, A.[2023]

The Metastatic Breast Cancer Project successfully gathered clinical and genetic data from over 2,000 patients in just seven months, demonstrating the power of social media in patient recruitment for clinical research.

This project could serve as a new model for recruiting participants in clinical trials for other cancer types, addressing the common challenge of finding enough volunteers through traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Media Ups Clinical Trial Enrollment. [2017]

The study involved 20 cancer patients who received a 160-page book on experimental therapies, showing that providing such information is both feasible and acceptable, with 89% to 95.5% of participants finding the book useful.

Participants who received the book later (at week 4) showed a significant increase in specific knowledge about clinical trials from 79% to 92.1%, indicating that the book effectively enhanced understanding and may influence decisions to participate in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and findings from a pilot randomized controlled intervention study on the impact of a book designed to inform patients about cancer clinical trials. Carney, PA., Tucker, EK., Newby, TA., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT06314672?draw=2&rank=1

Study Details | NCT06314672 | Outreach Project to ...

The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials. Detailed ...

2.

reporter.nih.gov

reporter.nih.gov/search/I_bJWIRR_0Kb3TKRVha0zw/project-details/11182529

Project Details - NIH RePORTER

The Connecting Patient Populations to Clinical Trials (CP2CT) program aims to implement and evaluate multilevel outreach and education interventions that will ...

3.

cancer.gov

cancer.gov/about-nci/organization/crchd/community-outreach/cusp2ct

CUSP2CT - NCI

A program designed to increase referral to NCI-supported clinical trials (CTs) among underrepresented racial/ethnic (R/E) minority populations.

4.

withpower.com

withpower.com/trial/outreach-project-for-cancer-clinical-trials-6e162

Outreach Project for Cancer Clinical Trials

The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials. Show more.

5.

grants.nih.gov

grants.nih.gov/grants/guide/rfa-files/RFA-CA-21-057.html

Expired RFA-CA-21-057: A Multilevel Approach to ...

CUSP2CT aims to employ CHEs, and LHAs as effective liaisons between the community and health care providers and care centers, and minority-serving institutions ...

6.

grants.nih.gov

grants.nih.gov/grants/guide/rfa-files/RFA-CA-22-014.html

Expired RFA-CA-22-014

The DECC is intended to support CUSP2CT, a program designed to increase referral to NCI-supported clinical trials (CTs) among underrepresented ...