Education Program for Increasing Clinical Trial Participation in Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Cognitive impairment

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?

This trial aims to educate and encourage participation in clinical trials, focusing on racial and ethnic minority groups and rural populations in Ohio. It seeks to improve understanding of clinical trials and their importance, especially for those facing a higher cancer burden. Participants will attend educational sessions led by community health educators and receive materials to enhance their knowledge and willingness to engage in clinical research. The trial seeks adults in Ohio who can understand and consent to participate in these educational sessions. As an unphased trial, it provides a unique opportunity to learn about and contribute to cancer research advancement without the commitment of a treatment study.

Do I need to stop my current medications to join the trial?

The trial does not specify whether you need to stop taking your current medications. It focuses on education about clinical trials rather than testing a specific treatment.

What prior data suggests that this educational intervention is safe?

Research has shown that educational programs in clinical trials are generally safe. Studies indicate they can help people understand and join trials without causing harm. For instance, one program guided patients through the process to encourage diverse participation in cancer trials. It increased involvement and reported no negative effects.

Another study found that these programs helped speed up the recruitment process for trials, especially in the later stages, with no safety issues noted. This evidence suggests that educational programs, like the one in this trial, are well-received and focus on providing information and support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a fresh approach to increasing participation in cancer clinical trials through education. Unlike traditional methods, which mainly focus on patient recruitment through healthcare providers, this approach involves direct educational sessions and materials provided by Community Health Educators (CHEs). This hands-on, personalized education method aims to empower patients with knowledge about clinical trials, potentially boosting participation rates and improving access to cutting-edge cancer treatments. By addressing the informational barriers that often prevent trial participation, this approach could lead to more inclusive and diverse clinical research.

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

Research has shown that educational programs can significantly increase participation in clinical trials, particularly among underrepresented groups. In this trial, participants will attend an educational session and receive materials to enhance understanding and support decision-making about clinical trial participation. Studies have found that patient navigation, which includes education and support, helps more people join cancer clinical trials. These programs simplify the importance of clinical trials and encourage consideration of participation. By offering clear information and guidance, educational programs enable informed choices about participation. This approach has successfully boosted trial participation rates and promoted diversity in clinical research. ^{1 2 5 6 7}

Who Is on the Research Team?

Electra D Paskett, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Ohio, particularly from racial/ethnic minority and rural populations. It aims to increase their participation in clinical trials. Those who cannot give informed consent due to cognitive impairment are excluded.

Inclusion Criteria

I am mentally capable of understanding and agreeing to participate.

I am an adult over 18 years old living in Ohio.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants attend an educational session with community health educators and receive educational materials

1 session

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in knowledge and clinical trial participation status

Up to 1 year

Extended Follow-up

Participants' prior clinical trial participation status is examined over an extended period

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention
• Health Education
• Survey Administration

Trial Overview The study tests an educational program designed by community health educators to boost understanding and involvement in clinical trials among underrepresented groups, focusing on the benefits of such research.

How Is the Trial Designed?

Group I: Health Services Research (educational session and materials) Experimental Treatment 3 Interventions

Participants attend an educational session with CHEs and receive educational materials on study.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Citations

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

Patient Navigator PRE-ACT Educational Intervention to ... This study focuses on psychosocial barriers at the patient level with the goal of promoting high quality decision making around clinical trials ...

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. 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 ...

4. 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 ...

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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03271099

Patient Navigation in Cancer Survivorship at a Safety Net ... 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213538321000369

Accelerating cancer clinical trial recruitment through a ... This study observed that the IMPACT intervention accelerated clinical trial recruitment, especially among late phase clinical trials.