Educational Platform Development for Cancer Clinical Trial Participation

Not currently recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Life-expectancy < 6 months, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore why minority patients might not participate in cancer clinical trials and how an educational platform can help. The focus is on understanding patient perspectives to create resources that could make joining a trial easier for underserved communities. Participants will receive educational materials, and some will also get help navigating the process. New cancer patients at a participating hematology oncology site who are willing to take part might be a good fit for this trial. As an unphased study, this trial offers a unique opportunity to contribute to making clinical trials more accessible and inclusive.

Do I have to stop taking my current medications for this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on educational aspects rather than medical treatment changes.

What prior data suggests that this educational intervention is safe?

Research has shown that educational programs and patient guidance are generally safe and well-received by participants. Studies have found that patient guidance helps people understand their treatment options without risk. These programs focus on providing support and information, without involving medications or medical procedures.

Past participants reported that these programs helped them make better decisions about their care. No major reports of negative effects have emerged from these educational and support activities, suggesting that participants are unlikely to experience problems from joining these programs.

In short, educational programs and patient guidance are designed to be safe and supportive, making them a low-risk choice for those interested in participating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to enhance participation in cancer clinical trials through innovative educational methods and patient support. Unlike usual practices that rely solely on standard educational materials, this trial uses a combination of video, booklets, and patient navigation to provide personalized and engaging information. By integrating these tools with active clinical trial matching and access through electronic medical records, the approach is more comprehensive and patient-centric. The hope is that this will improve patients' understanding and willingness to participate in trials, potentially leading to more effective cancer treatments.

What evidence suggests that this trial's educational interventions could be effective for increasing clinical trial participation among minority cancer patients?

Research has shown that educational programs combined with patient guidance can greatly increase participation in clinical trials. In this trial, participants in Part II: Arm A will receive clinical trial education through a video and educational booklet, followed by standard of care follow-up. Meanwhile, participants in Part II: Arm B will receive the same educational materials but will also undergo patient navigation, which includes active clinical trial matching and receiving clinical trial information through the electronic medical record portal. Studies have found that patient guidance helps people understand clinical trials better and overcome obstacles to joining them. For example, one study found that patient guidance increased trial enrollment rates from about 7% to nearly 22% among cancer patients. Additionally, patient guidance improves cancer screening and speeds up diagnosis and treatment. Overall, these methods can make clinical trials more accessible and easier to understand, especially for underserved communities. ^{1 2 3 6 7}

Who Is on the Research Team?

Sikander Ailawadhi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with any cancer diagnosis who are new to hematology oncology at the treating site. Participants must be willing to provide informed consent. It focuses on minority patient populations and aims to understand their challenges and preferences regarding clinical trial participation.

Inclusion Criteria

PART II: Subjects must be willing to provide informed consent for the study

PART I: Subjects must be identified as new patients to hematology oncology at the treating site

PART I: Subjects must be willing to provide informed consent for the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part I: Questionnaire and Medical Record Review

Participants complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Medical records are reviewed.

Baseline

Part II: Clinical Trial Education

Participants undergo clinical trial education via a video and educational booklet. Arm A receives standard of care follow-up, while Arm B undergoes patient navigation with active clinical trial matching.

Up to 24 months

Follow-up

Participants are monitored for changes in knowledge score and patient enrollment in clinical trials.

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention
• Patient Navigation

Trial Overview The study tests an educational intervention, including questionnaires, best practices review, electronic health record examination, and patient navigation. The goal is to develop a personalized platform that could increase clinical trial involvement among underserved cancer patients.

How Is the Trial Designed?

Group I: Part II: Arm B (clinical trial education, navigation) Experimental Treatment 5 Interventions

Patients undergo clinical trial education via a video and educational booklet and then undergo patient navigation with active clinical trial matching and receive clinical trial information through the electronic medical record portal on study.

Group II: Part I (questionnaire, medical record review) Experimental Treatment 2 Interventions

Patients complete a questionnaire about their preferences, understanding, and attitudes regarding clinical trials. Patients also have their medical records reviewed.

Group III: Part II: Arm A (clinical trial education, standard of care) Active Control 4 Interventions

Patients undergo clinical trial education via a video and educational booklet and then standard of care follow-up on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

Patient navigation significantly enhances patients' involvement in their cancer treatment, particularly by addressing emotional and informational needs, as highlighted in interviews with 28 cancer patients.

The study emphasizes the importance of a strong partnership between patients and navigators, suggesting that emotional support and effective communication are more critical than logistical assistance in the navigation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis. Rousseau, SJ., Humiston, SG., Yosha, A., et al.[2021]

A nationwide survey of 527 oncology navigators revealed that clinical navigators (76.1% of participants) are more likely to have higher education (88.6% with a bachelor's degree or higher) and are primarily funded by operational budgets, indicating a more stable employment environment compared to nonclinical navigators.

Clinical navigators provide a wider range of services, including basic navigation, care coordination, and treatment support, and are more engaged in critical areas of cancer care such as treatment, end-of-life, and palliative care navigation, highlighting their essential role in the cancer care continuum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing clinical and nonclinical cancer patient navigators: A national study in the United States. Wells, KJ., Wightman, P., Cobian Aguilar, R., et al.[2023]

The original patient navigation programs effectively combined community involvement and culturally sensitive care coordination to address disparities in cancer care, particularly for racial and ethnic minorities.

These programs functioned as a system rather than relying on individual navigators, with a structured team of navigators and directors working together to remove barriers and facilitate patient access to care, highlighting the importance of administrative support and community engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. Vargas, RB., Ryan, GW., Jackson, CA., et al.[2011]

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]

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]

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]

In a randomized controlled trial involving 319 patients with breast and colorectal cancer, patient navigation did not show a statistically significant effect on cancer-specific quality of life (QOL) compared to usual care.

While the emotional well-being of the patient navigation group showed a change that approached significance, overall QOL measures did not differ significantly, suggesting that patient navigation may not enhance QOL during cancer treatment in this study's context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. Hendren, S., Griggs, JJ., Epstein, R., et al.[2021]

A study observing 34 patient navigators across nine programs revealed six distinct patterns of activity, highlighting the balance between direct patient interaction and administrative tasks like managing medical records.

Patient navigators play a crucial role not only in assisting patients but also in ensuring the health system functions effectively, suggesting that organizations should consider these roles when designing patient care systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of task and network actions performed by navigators to facilitate cancer care. Clark, JA., Parker, VA., Battaglia, TA., et al.[2014]

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]

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 (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

The study analyzed patient navigator activities in 10 breast cancer navigation programs, revealing that individual-level tasks were consistently aligned with the published navigation model, emphasizing the importance of personalized support for patients.

However, there was significant variation in program-level principles, suggesting that factors like the use of volunteer versus clinical navigators influenced how closely programs adhered to the model, indicating a need for tailored guidance to meet community-specific needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of patient navigator activities in breast cancer patient navigation programs using a nine-principle framework. Gunn, CM., Clark, JA., Battaglia, TA., et al.[2021]

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 ... Navigation services may help patients learn about clinical trials, identify and overcome barriers, and progress through the care pathway to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00375024

Study Details | NCT00375024 | Patient Navigator Project 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, two ...

5. 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 ...

6. trialx.com trialx.com/clinical-trials/listings/231336/patient-navigator-pre-act-educational-intervention-to-promote-decision-making-among-minorities/?&geo_lat=41.4169974&geo_lng=-81.6059581&radius=10&place=Garfield%20Heights&user_country=United%20States

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 ...

7. 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.