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

Trial Summary

What is the purpose of this trial?

This study focuses on psychosocial barriers at the patient level with the goal of promoting high quality decision making around clinical trials participation. The proposed study adapts the PRE-ACT model to racial and ethnic minority patients who were underrepresented in the original PRE-ACT study and will be combined with a patient navigator model.

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 data supports the effectiveness of the treatment Educational Intervention, PRE-ACT Model, Patient Navigator Model?

Research shows that patient navigation, which is part of this treatment, can help reduce healthcare disparities by guiding patients through the healthcare system, especially in underserved communities. This approach has been promising in improving timely cancer care and addressing barriers faced by minority and low-income patients. ^{1 2 3 4 5}

Is the Educational Intervention for Disparities in Clinical Trial Access safe for humans?

The research articles do not provide specific safety data for the Educational Intervention, PRE-ACT Model, or Patient Navigator Model. However, these interventions focus on improving access and participation in clinical trials rather than involving direct medical treatments, suggesting they are generally safe as they do not involve physical health risks. ^{6 7 8 9 10}

How does the treatment in the Educational Intervention for Disparities in Clinical Trial Access differ from other treatments?

This treatment is unique because it focuses on patient navigation and communication coaching to address disparities in clinical trial access, particularly for low-income and minority patients. Unlike traditional medical treatments, it aims to eliminate barriers such as social and financial obstacles and improve communication, making it a novel approach to improving healthcare access. ^{1 2 4 5 11}

Research Team

Lauren Chiec, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

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

Navigation as an intervention to eliminate disparities in American Indian communities. [2021]

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

Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. [2022]

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

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual. [2023]

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

Dissemination of patient navigation programs across the United States. [2022]

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

Study protocol: a randomized controlled trial of patient navigation-activation to reduce cancer health disparities. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Adolescent knowledge and attitudes related to clinical trials. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Racial and Ethnic Disparities in Adverse Drug Events: A Systematic Review of the Literature. [2021]

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

Building Community-Engaged Multidisciplinary Partnerships to Improve Medication Management in Elderly Patients With Multiple Chronic Conditions. [2022]

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

Unequal burden of disease, unequal participation in clinical trials: solutions from African American and Latino community members. [2022]

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

A lay patient navigation training curriculum targeting disparities in cancer clinical trials. [2022]

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

A national patient navigator training program. [2021]