Educational Platform Development for Cancer Clinical Trial Participation

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

590 Participants Needed

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.

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 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 data supports the effectiveness of the treatment Educational Intervention, PRE-ACT Model, Patient Navigator Model, Patient Navigation, Patient Navigation Services, Care Coordination, Healthcare Navigation?

Research shows that patient navigation, a key part of this treatment, helps improve the quality of life for cancer patients and speeds up important steps in cancer care, like diagnosis and starting treatment. ^{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 educational platform for cancer clinical trial participation safe for humans?

The research articles focus on the effectiveness and implementation of patient navigation and educational interventions in cancer clinical trials, but they do not provide specific safety data. These interventions are generally considered safe as they involve guidance and support rather than medical treatments. ^{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}

Research Team

Sikander Ailawadhi, MD

Principal Investigator

Mayo Clinic

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

Timeline

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

Treatment Details

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.

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.

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+

Findings from Research

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]

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 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 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]

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 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]

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]

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]

References

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

Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. [2022]

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]

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

A national patient navigator training program. [2021]

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

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]

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]

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

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

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

Patterns of task and network actions performed by navigators to facilitate cancer care. [2014]

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

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

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

Statewide cancer clinical trial navigation service. [2022]

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

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

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

Patient navigation moderates emotion and information demands of cancer treatment: a qualitative analysis. [2021]

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

Comparing clinical and nonclinical cancer patient navigators: A national study in the United States. [2023]

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]