Educational Intervention for Disparities in Clinical Trial Access

Overseen By Lauren Chiec, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

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

Compensation: Varies

Number of Visits: 2

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help minority patients, particularly those with cancer, better understand their options for joining clinical trials. Participants will watch educational videos and work with a patient navigator to discuss any concerns about joining a trial. The goal is to ensure everyone has the information needed to make confident healthcare decisions. This trial suits non-white or Hispanic individuals diagnosed with advanced or early-stage cancer who are currently receiving cancer-related care. As an unphased trial, it offers a unique opportunity to gain valuable insights and support in navigating clinical trial options.

Will I have to stop taking my current medications?

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

What prior data suggests that this educational intervention is safe?

Studies have shown that educational programs, like the one in this trial, are generally safe. Research indicates that patient navigators—individuals who explain clinical trials—can improve decision-making without causing harm. This approach is not a medical treatment; it resembles having a coach for guidance. Consequently, no reports of negative side effects or risks are associated with it. The focus is on providing support and information to help people make informed choices about joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Educational Intervention for Disparities in Clinical Trial Access because it offers a tailored approach to overcoming barriers that many patients face when considering clinical trials. Unlike traditional methods that may not address individual patient needs, this intervention uses personalized educational videos and patient navigation to directly tackle specific obstacles identified for each participant. This approach aims to increase awareness and preparedness among patients, potentially leading to greater participation in clinical trials and helping to address disparities in trial access.

What evidence suggests that this educational intervention is effective for improving clinical trial access?

This trial will evaluate an educational intervention designed to address disparities in clinical trial access. Research has shown that education and guidance can help people understand clinical trials, making it easier for them to decide about joining. For instance, patient navigators, part of the PRE-ACT Adaptation arm in this trial, assist individuals in understanding the trial process, simplifying participation. One study found that patient navigators can increase the number of participants, especially from minority groups, in clinical trials. Another study demonstrated that providing information tailored to a person's specific needs can address concerns and improve understanding. Overall, these methods aim to remove obstacles and empower patients to make informed decisions about participating in clinical trials. ^{1 2 6 7 8}

Who Is on the Research Team?

Lauren Chiec, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for non-white or Hispanic adults with advanced cancer or early stage disease under treatment or surveillance. They must be over 18, able to read and speak English, have a life expectancy over three months, and give written consent.

Inclusion Criteria

I have advanced cancer or early stage cancer and am under treatment or surveillance.

Participants have a non-white race or Hispanic ethnicity recorded in their patient demographics in the electronic medical record

Participant must have a life expectancy greater than three months based on the primary oncology team's clinical assessment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants receive a tailored educational intervention and patient navigation program to address knowledge and attitudes towards clinical trials

3 months

1 visit (in-person) for consent and surveys, followed by educational videos and discussion

Post-Intervention Follow-up

Participants are contacted via phone to complete a Post-Intervention Survey assessing knowledge, attitudes, and preparation related to participation in clinical trials

4 weeks

1 contact (phone)

Long-term Follow-up

Chart review performed to assess if the patient participated in a clinical trial

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention

Trial Overview The study tests an educational program adapted from the PRE-ACT model combined with patient navigation to help minority patients make informed decisions about participating in clinical trials.

How Is the Trial Designed?

Group I: PRE-ACT Adaptation Experimental Treatment 1 Intervention

At the scheduled oncologic visit: consent obtained and all participants will complete the Demographics/Clinical Characteristics survey and Pre-Intervention Survey Within 3 months of consent: tailored educational intervention and patient navigation program will take place and the scored Pre-Intervention survey will be used to generate a list of barrier for each patient. The patient will be asked to view educational videos on an iPad that correspond with each identified barrier. Afterwards, the patient navigator will lead a discussion based on the topics discussed. Within 4 weeks of the educational video: the participant will be contacted via phone to complete a Post-Intervention Survey that assesses knowledge, attitudes, and preparation related to participation in clinical trials Two years after intervention: chart review will be performed to assess if the patient participated in a clinical trial.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

African-Americans face significant barriers to clinical trial enrollment for thoracic cancers, with less than 3% of newly diagnosed cancer patients participating in trials, and only 10% of those being ethnic minorities.

Implementing a patient navigation program can enhance the confidence and understanding of lay navigators, potentially improving clinical trial enrollment among African-Americans, though further research is needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lay patient navigation training curriculum targeting disparities in cancer clinical trials. Bryant, DC., Williamson, D., Cartmell, K., et al.[2022]

A study of 82 adolescents in southeast Michigan revealed that only 33% had heard of clinical trials, indicating a significant lack of awareness and knowledge about them, particularly among minority groups.

Minority students showed poorer knowledge and more negative attitudes towards clinical trials compared to non-Hispanic whites, highlighting the need for targeted educational interventions to improve awareness and participation in clinical trials among these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent knowledge and attitudes related to clinical trials. Brown, DL., Cowdery, JE., Jones, TS., et al.[2022]

A systematic review of 40 studies found that racial and ethnic disparities exist in adverse drug events (ADEs) related to specific medication classes, with Asians at higher risk for anticoagulant-related ADEs, Black patients for diabetes agents, and Whites for opioid-related ADEs.

Despite identifying these disparities, the studies often lacked a standardized approach to racial/ethnic categorization and did not adequately control for confounding factors, highlighting the need for more targeted research and interventions to reduce ADEs in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial and Ethnic Disparities in Adverse Drug Events: A Systematic Review of the Literature. Baehr, A., Peña, JC., Hu, DJ.[2021]

Patient navigation programs have shown a low refusal rate (4%-6%) for clinical trial participation among medically underserved populations, indicating potential effectiveness in reducing barriers to enrollment.

However, there is a need for more research to evaluate the overall efficacy of these programs in increasing clinical trial enrollment, as few studies have reported on this outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual. Ghebre, RG., Jones, LA., Wenzel, JA., et al.[2023]

A study involving 57 adults (32 African Americans and 25 Latinos) identified key barriers to clinical trial participation, emphasizing the need for tailored solutions that address cultural and historical contexts.

Participants suggested solutions such as improving community recruitment, providing education in familiar settings, and ensuring trust by diversifying research teams and offering language support, which could enhance participation rates among underrepresented groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unequal burden of disease, unequal participation in clinical trials: solutions from African American and Latino community members. Ford, ME., Siminoff, LA., Pickelsimer, E., et al.[2022]

The Rochester Patient Navigation Research Program is a randomized clinical trial involving 344 newly-diagnosed breast and colorectal cancer patients, aiming to reduce health disparities by combining patient navigation and communication coaching.

The intervention provides tailored support from trained navigators to improve patients' access to care, adherence, and overall satisfaction, potentially leading to better health outcomes and self-efficacy in managing their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities. Hendren, S., Griggs, JJ., Epstein, RM., et al.[2022]

Patient navigation programs are widely distributed across the U.S. and are particularly prevalent in high-poverty areas, where they often employ lay navigators to assist underserved populations.

These programs are typically located in community health centers and religious organizations, highlighting their role in improving access to care for individuals facing economic and health care disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of patient navigation programs across the United States. Hedlund, N., Risendal, BC., Pauls, H., et al.[2022]

Engaging minority elderly patients in the research process led to the identification of key medication safety issues, such as concerns about drug advertisements (79%) and drug interactions (70%), highlighting the importance of patient perspectives in improving medication safety.

The project successfully involved patients and caregivers in developing research strategies, resulting in the creation of three grant proposals aimed at addressing drug-related problems, demonstrating a collaborative approach to enhancing medication safety for seniors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Community-Engaged Multidisciplinary Partnerships to Improve Medication Management in Elderly Patients With Multiple Chronic Conditions. Poon, IO., Skelton, F., Bean, LR., et al.[2022]

In a study involving 10,521 participants with abnormal cancer screenings and 2,105 with cancer diagnoses, patient navigation significantly improved the timeliness of diagnostic resolution and treatment initiation after 90 days, with adjusted hazard ratios of 1.51 and 1.43, respectively.

The effectiveness of patient navigation was particularly notable in centers where there were greater delays in follow-up care, suggesting that this intervention is especially beneficial for populations at risk of being lost to follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. Freund, KM., Battaglia, TA., Calhoun, E., et al.[2022]

A successful patient navigation program for American Indian populations in the Northern and Southern Plains increased community knowledge about cancer and improved cancer screening behaviors through 24-hour workshops.

Collaboration with trusted Native Patient Navigators helped bridge the gap between patients and healthcare providers, enhancing adherence to care recommendations and ultimately improving quality of life and survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation as an intervention to eliminate disparities in American Indian communities. Krebs, LU., Burhansstipanov, L., Watanabe-Galloway, S., et al.[2021]

A standardized national training program for patient navigators (PNs) was successfully implemented, attended by 116 PNs from 85 cities, aimed at reducing cancer health disparities for medically underserved populations.

The training showed significant efficacy, with overall improvements in posttest scores compared to pretest scores, particularly among participants with higher education levels or more work experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A national patient navigator training program. Calhoun, EA., Whitley, EM., Esparza, A., et al.[2021]

Citations

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Effectiveness of Patient Navigation During Transition to ... Results suggest that the navigator intervention may not reduce emergency department visits in this population.

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Study Protocol: A randomized controlled trial of patient ... The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317281/

Implementation of a Patient Navigation Program to Support ... Navigation services may help patients learn about clinical trials, identify and overcome barriers, and progress through the care pathway to ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05294042

Patient Navigators for Children's Community Mental Health ... A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Patient navigation is a strategy for overcoming barriers to reduce disparities and to improve access and outcomes. The aim of this umbrella ...