Educational Program for Clinical Trial Participation in Cancer

Overseen By Jose Barron

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Non-English/Spanish, Cognitive impairment, Vulnerable populations, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to boost participation in cancer clinical trials by educating people about the benefits and availability of these studies. It focuses on reaching underrepresented groups, such as Hispanics, people in rural areas, and those in poverty in Colorado. The trial employs an educational approach, known as the Educational Intervention, to inform and motivate current cancer patients who have not yet joined a clinical trial. A suitable candidate for this trial speaks English or Spanish and lives in an underrepresented community. As an unphased trial, it offers a unique opportunity to learn about and potentially benefit from clinical trials, especially for those who have not previously participated.

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?

Research has shown that educational programs, such as patient navigation, are safe and user-friendly. Studies have found that these programs increase participation in cancer care without risk. For instance, patient navigation guides patients through cancer screenings and accelerates diagnosis. Since these programs do not involve drugs or medical procedures, they cause no physical side effects or adverse reactions. Participants typically find them helpful and supportive in understanding treatment options. Overall, educational programs are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Educational Intervention because it aims to enhance clinical trial participation among underrepresented populations, such as Hispanics and those living in rural or impoverished areas. Unlike traditional cancer treatments that focus solely on medical interventions, this program addresses the significant barrier of awareness and education, which is crucial for improving access to cutting-edge therapies. By empowering these communities with knowledge, the program has the potential to diversify clinical trial participation and ensure that new cancer treatments are effective across a broader demographic.

What evidence suggests that this educational intervention is effective for improving clinical trial participation in cancer?

Research has shown that educational programs, such as patient navigation, can significantly increase participation in clinical trials, particularly among underrepresented groups. This trial's educational intervention will focus on underrepresented populations, including Hispanics, residents of rural areas, and those in poverty-stricken regions. These programs guide patients through the healthcare system, facilitating their participation in trials. For example, patient navigation has successfully increased cancer screenings and expedited diagnoses. This approach also helps more participants remain in trials once they join. Overall, these educational efforts reduce disparities in cancer care and trial participation, offering a promising way to improve outcomes. ^{1 2 3 4 5}

Who Is on the Research Team?

Evelinn Borrayo

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English or Spanish and are part of underrepresented populations in Colorado. They must be willing to learn about clinical trials, consent to participate, and be available throughout the study. It excludes non-English/Spanish speakers, decisionally-challenged individuals, vulnerable groups like inmates or homeless people, and anyone under 18.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.

Stated willingness to comply with all study procedures and be available for the duration of the study

Provision to sign and date the consent form

Exclusion Criteria

I am under 18 years old.

I am able to make decisions for myself and am not impaired by substances or cognitive issues.

Individuals from vulnerable populations (e.g., inmates, homeless, pregnant women, and those with auditory impairment) [at the discretion of the CHE or PN upon recruitment]

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Community Health Educators conduct workshops to educate participants about the importance of participating in cancer clinical trials.

1 week

1 visit (in-person)

Referral and Tracking

Patient Navigators set up communication pathways and track referrals to clinical trials.

36 months

Follow-up

Participants are monitored for changes in knowledge and understanding of clinical trials and their participation.

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention

Trial Overview The trial tests an educational intervention designed to increase awareness and participation in clinical trials among underrepresented communities. The focus is on Hispanics, rural residents, and those living in poverty within Colorado's catchment area.

How Is the Trial Designed?

Group I: Underrepresented Population Experimental Treatment 1 Intervention

A primary emphasis is placed on those from underrepresented populations, including Hispanics, residents of outlying rural areas, and those in areas of poverty

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Patient navigators play a crucial role in reducing cancer disparities by helping underserved populations with insurance, financial, and logistical challenges, which can lead to improved access to care.

The implementation of a multisite patient navigator program across five cancer institutions in Western Pennsylvania demonstrates the potential for these programs to enhance cancer care and facilitate future research in addressing health inequities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the healthcare divide with patient navigation: development of a research program to address disparities. Schwaderer, KA., Itano, JK.[2021]

The navigation program for cancer patients showed marginally lower rates of emergency room visits and unplanned hospitalizations among those who used the service, indicating some potential benefits in care coordination.

However, the program had low visibility and utilization among patients, and overall patient experiences were mixed, suggesting that a more focused approach may be needed to effectively support high-risk or anxious patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. Winget, M., Holdsworth, L., Wang, S., 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]

The use of patient navigators significantly improved the retention of African American patients in cancer clinical trials, with a completion rate of 74.5% for those receiving support compared to only 37.5% for those who did not.

Overall participation of African Americans in therapeutic cancer clinical trials increased from 9% to 16%, demonstrating that patient navigation can effectively enhance minority involvement in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials. Fouad, MN., Acemgil, A., Bae, S., 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]

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]

The Choices intervention, which included an educational video and patient navigation support, significantly improved Latina breast cancer patients' understanding of clinical trials and their willingness to consider them as a treatment option, compared to a control group.

Participants in the Choices group showed marked improvements in decision readiness, with agreement on preparation to take action increasing from 52.8% to 86.1%, indicating that tailored educational strategies can enhance informed decision-making about clinical trial participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Latina breast cancer patients to make informed decisions about clinical trials: a pilot study. Chalela, P., Muñoz, E., Gallion, KJ., et al.[2021]

A 1-hour online training course significantly improved primary care providers' (PCPs) general and local knowledge about cancer clinical trials, with knowledge gains sustained for at least 3 months after the training.

Following the training, 52% of PCPs reported discussing clinical trials with cancer patients, indicating that the training influenced their behavior and could potentially enhance patient participation in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of an Online Training Program About Cancer Clinical Trials on Primary Care Physicians' Knowledge, Attitudes and Beliefs, and Behavior. Bylund, CL., Michaels, M., Weiss, ES., 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]

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]

A lay navigation intervention for cancer patients significantly improved their understanding of clinical trials (CT), with pre- and post-test scores showing a notable increase (from 3.54 to 4.40, p-value 0.004).

The intervention also led to a high consent rate for CT participation, with 95% of navigated patients agreeing to enroll, indicating that lay navigators can effectively support patients in overcoming barriers to trial participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient participation in cancer clinical trials: A pilot test of lay navigation. Cartmell, KB., Bonilha, HS., Matson, T., 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 web-based decision support tool (CHOICES DST) was developed to help Black and Hispanic cancer patients understand and make informed decisions about participating in cancer clinical trials, addressing the low participation rates of these groups.

Usability testing with cancer survivors showed that the CHOICES DST was well-received, with users expressing satisfaction with its content and navigation, indicating its potential to enhance knowledge and decision-making regarding clinical trial participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives. Langford, AT., Hawley, ST., Stableford, S., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05701085

Patient Navigator PRE-ACT Educational Intervention to ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6197623/

Patient navigation and clinical trial participation This patient navigation and clinical trial participation study is a randomized controlled trial to assess the effect of a patient navigator on enrollment into ...

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

Implementation of a Patient Navigation Program to Support ... We implemented a patient navigation program to support diverse enrollment and retention of patients in cancer clinical trials; the proximal ...

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

Patient navigation across the cancer care continuum: An ... Patient navigation is effective in improving participation in cancer screening and reducing the time from screening to diagnosis and from ...

5. ascopubs.org ascopubs.org/doi/10.1200/EDBK_100026

Navigating a Path to Equity in Cancer Care: The Role of ... Patient navigation is an important intervention that addresses cancer disparities throughout the cancer care continuum.