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

188 Participants Needed

Trial Summary

What is the purpose of this trial?

This proposal aims to leverage ongoing community outreach efforts and the Cancer Center's aims to improve recruitment to clinical trials by educating the catchment and making referrals to engage current UCCC patients not taking advantage of available CTs at this institution and affiliated hospitals. The Cancer Prevention and Control Program within UCCC works to develop and evaluate novel approaches to primary prevention, disseminate preventative interventions in population-based settings, and to improve health services delivery and outcomes for cancer patients and survivors. A primary emphasis is placed on those from underrepresented populations, including Hispanics, residents of outlying rural areas, and those in areas of poverty. Efforts to meet the Cancer Center's priorities include interventions to promote awareness and recruitment of eligible patients to available CTs in the catchment area (the state of Colorado).

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 for clinical trial participation in cancer?

Research shows that educational programs and patient navigation can improve understanding and decision-making about clinical trials. For example, a study with Latina breast cancer patients found that a similar intervention increased their understanding and consideration of clinical trials as a treatment option. ^{1 2 3 4 5}

Is the educational program for clinical trial participation in cancer safe for humans?

The research articles reviewed do not provide specific safety data for the educational program itself, but they do indicate that the interventions, such as decision support tools and patient navigation, were well-received and showed positive outcomes in terms of understanding and decision-making without mentioning any safety concerns. ^{1 2 6 7 8}

How does this treatment differ from other cancer treatments?

This treatment is unique because it involves an educational program using patient navigators to help increase participation in cancer clinical trials, especially among minorities. Unlike traditional treatments, it focuses on overcoming barriers to trial enrollment and providing support and education to patients. ^{9 10 11 12 13}

Research Team

Evelinn Borrayo

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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 speak English or Spanish.

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

Exclusion Criteria

I am under 18 years old.

I speak English or Spanish and meet all other eligibility criteria.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

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 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]

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 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 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]

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]

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]

References

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

Empowering Latina breast cancer patients to make informed decisions about clinical trials: a pilot study. [2021]

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

Statewide cancer clinical trial navigation service. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

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

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

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England 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. [2022]

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

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. [2021]

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

Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials. [2022]

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

A national patient navigator training program. [2021]

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

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

13. Netherlands pubmed.ncbi.nlm.nih.gov

Patient participation in cancer clinical trials: A pilot test of lay navigation. [2023]