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

Trial Summary

What is the purpose of this trial?

This clinical trial tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Progress in cancer prevention, detection and treatment can only be made by identifying and validating new and improved methods, compounds and modalities in clinical trials. Unfortunately, participation in clinical trials is not equal across all racial and ethnic groups, limiting progress against cancer in all population groups and further widening the disparity gap. To change this picture, concerted effort needs to be directed both at the communities at risk for being left out of trials and the systems that cause the disparities at all levels involved in accrual to clinical trials. The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials.

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 data supports the idea that Outreach Project for Cancer Clinical Trials (also known as: CUSP2CT Project) is an effective treatment?

The available research shows that efforts to improve communication and provide information about cancer clinical trials can be effective. For example, a study involving a video intervention for blood cancer patients and their caregivers showed that participants gained knowledge and confidence in discussing clinical trials with their doctors. Another study found that providing a book about cancer clinical trials increased patients' knowledge and helped them make informed decisions about participating in trials. These findings suggest that initiatives like the CUSP2CT Project, which aim to increase awareness and understanding of clinical trials, can be effective in encouraging participation and improving outcomes for patients. ^{1 2 3 4 5}

What safety data exists for the CUSP2CT Project treatment?

Phase I and II trials are the first steps in testing new treatments in humans to see if they are safe and how well people can tolerate them. These trials often report on side effects, but the way this information is shared can vary, making it hard to compare results across different studies. ^{6 7 8 9 10}

How does this treatment differ from other cancer treatments?

The Outreach Project for Cancer Clinical Trials is unique because it focuses on increasing participation in cancer clinical trials, especially among underserved and minority communities, through community-based education and advocacy efforts. This approach aims to improve awareness and access to clinical trials, which is different from traditional treatments that do not typically address these barriers to participation. ^{1 11 12 13 14}

Research Team

Electra D. Paskett, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Involving American Indians and medically underserved rural populations in cancer clinical trials. [2022]

2. England 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. [2023]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Statewide cancer clinical trial navigation service. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Patient advocacy organizations' information for patients on pre-approval access to investigational treatments. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. [2021]

7. England 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). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Preventing Potential Patient Harm Through Clinical Content Interventions During Oncology Clinical Trial Implementation. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Improving attribution of adverse events in oncology clinical trials. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Reducing Uninformative IND Safety Reports: A List of Serious Adverse Events anticipated to Occur in Patients with Lung Cancer. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Discussing randomised clinical trials of cancer therapy: evaluation of a Cancer Research UK training programme. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Social Media Ups Clinical Trial Enrollment. [2017]

13. England pubmed.ncbi.nlm.nih.gov

Evaluating a community-partnered cancer clinical trials pilot intervention with African American communities. [2022]

14. England pubmed.ncbi.nlm.nih.gov

"The promise of community-based advocacy and education efforts for increasing cancer clinical trials accrual". [2022]