Educational Platform Development for Cancer Clinical Trial Participation

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Sikander Ailawadhi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?

This clinical trial investigates the challenges, behavioral patterns, and preferences towards participation in clinical trials in minority patient populations in order to develop a personalized clinical trial educational platform to increase participation in clinical trials among underserved cancer patients. Learning more about patients' understanding of clinical trials may help identify barriers that limit patient's participation. Information gathered from this trial will be used to develop educational materials that may aid minority patients in overcoming barriers to participating in clinical trials. A personalized clinical trial educational platform may help increase participation in clinical trials among minority populations.

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.

What data supports the idea that Educational Platform Development for Cancer Clinical Trial Participation is an effective treatment?

The available research shows that Educational Platform Development for Cancer Clinical Trial Participation, also known as patient navigation, is effective in improving cancer care. For example, one study found that patient navigation helps improve the quality of life for newly diagnosed cancer patients. Another study highlighted that patient navigation can reduce the time it takes for patients to move through key stages of cancer care, such as diagnosis and starting treatment. Additionally, a national training program for patient navigators showed that participants improved their skills, which can help reduce health disparities for underserved patients. These findings suggest that patient navigation is a beneficial treatment for improving cancer care and supporting patients through their treatment journey. ^{1 2 3 4 5}

What safety data exists for educational platforms in cancer clinical trials?

The research does not provide specific safety data for educational platforms or patient navigation models in cancer clinical trials. The studies focus on the effectiveness and feasibility of these interventions in improving clinical trial enrollment and care coordination, particularly among minority groups, but do not address safety concerns. ^{6 7 8 9 10}

Is the treatment in the Educational Platform Development for Cancer Clinical Trial Participation a promising treatment?

Yes, the treatment is promising because it focuses on patient navigation, which helps cancer patients overcome barriers to getting diagnosed and treated. This approach improves care coordination and supports patients emotionally and informationally during their treatment, making it easier for them to participate in clinical trials and receive the care they need. ^{3 10 11 12 13}

Eligibility Criteria

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

Treatment Details

Interventions

• Educational Intervention (Behavioural Intervention)
• Patient Navigation (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Florida Jacksonville, FL

Cancer Specialists of North Florida-Saint Vincent's Jacksonville, FL

Mayo Clinic in Arizona Scottsdale, AZ

Mayo Clinic in Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

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

Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. [2022] Patient navigation is a promising intervention to address cancer disparities but requires a multisite controlled trial to assess its effectiveness.

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

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. [2021] Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer.

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

A national patient navigator training program. [2021] Patient Navigation is an intervention aimed at addressing cancer health disparities by eliminating barriers to diagnosis, treatment, and services. Three major patient navigation (PN) programs (The National Cancer Institute, The American Cancer Society &The Center for Medicare and Medicaid Services) are underway to address the needs of medically underserved cancer patients. There has not been national training with a defined curriculum for patient navigators (PNs). Curriculum for training the PNs was created by experts from the three programs. The efficacy of training was evaluated using a pre- and posttest. The data show that overall the posttest scores improved from the pretest. In addition, having a high school education or greater or having more years of work experience were significantly related to improvements on the posttest. The first successful standardized national training program was attended by 116 PNs representing 85 cities with the goal to reduce health disparities for medically underserved.

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

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021] Patient navigation (PN) is an emerging strategy to overcome barriers to cancer care. We evaluated the efficacy of PN in improving time of key events in cancer care, including positive screening tests, definitive diagnosis, initiation of therapy, and completion of initial therapy.

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

An assessment of patient navigator activities in breast cancer patient navigation programs using a nine-principle framework. [2021] To determine how closely a published model of navigation reflects the practice of navigation in breast cancer patient navigation programs.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Patient participation in cancer clinical trials: A pilot test of lay navigation. [2023] Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators.

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

Patterns of task and network actions performed by navigators to facilitate cancer care. [2014] Patient navigation is a widely implemented intervention to facilitate access to care and reduce disparities in cancer care, but the activities of navigators are not well characterized.

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

Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials. [2022] Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute-designated comprehensive cancer center.

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

Statewide cancer clinical trial navigation service. [2022] Realizing that education and awareness are paramount in making clinical trials available to improve overall accrual rates, we sought to create a clinical trial navigation service to improve the accessibility of cancer clinical trials in Florida for physicians and patients. This study was undertaken to evaluate this service. We hoped to identify characteristics of our service that were effective in promoting clinical trial enrollment and to better understand barriers that prevented enrollment.

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

Effectiveness of a Lay Navigation Program in an Academic Cancer Center. [2021] A navigation program with lay navigators that targets patients with cancer who are receiving multiple treatment modalities was launched with the goal of improving care coordination.

11. Germany pubmed.ncbi.nlm.nih.gov

Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis. [2021] Patient navigation is increasingly employed to guide patients through cancer treatment. We assessed the elements of navigation that promoted patients' involvement in treatment among patients with breast and colorectal cancer that participated in a navigation study.

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

Comparing clinical and nonclinical cancer patient navigators: A national study in the United States. [2023] A nationwide survey was conducted to examine differences between clinical and nonclinical oncology navigators in their service provision, engagement in the cancer care continuum, personal characteristics, and program characteristics.

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

Characteristics of the original patient navigation programs to reduce disparities in the diagnosis and treatment of breast cancer. [2011] Patient navigation is an intervention developed to reduce disparities in cancer care that is being widely replicated and receiving considerable support for demonstration projects and research to test its effectiveness. In the current study, the authors present an in-depth descriptive analysis of the original patient navigation programs to inform current and future program development.