Education Program to Promote Cancer Screenings

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gallaudet University

Disqualifiers: Full hearing, Age cutoff, Cancer treatment, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Intervention to promote cancer screenings among deaf, deafblind, and hard of hearing participants who have not received screening within the recommended guideline.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on promoting cancer screenings, so it's unlikely that your medications will be affected.

What data supports the effectiveness of the treatment Community Health Navigator Program in promoting cancer screenings?

Research shows that patient navigation programs, similar to the Community Health Navigator Program, can increase participation in cancer screenings by 10.8% to 17.1% and improve follow-up care adherence by 21% to 29.2%, helping more people get the screenings and care they need. ^{1 2 3 4 5}

Is the Education Program to Promote Cancer Screenings safe for participants?

The research articles provided do not contain specific safety data for the Education Program to Promote Cancer Screenings or similar programs like the Community Health Navigator Program. ^{6 7 8 9 10}

How does the Community Health Navigator Program treatment differ from other treatments for promoting cancer screenings?

The Community Health Navigator Program is unique because it uses trained individuals to guide and support patients, especially those who are underserved, through the process of getting cancer screenings. This approach focuses on reducing barriers and improving access to preventive care, which is different from traditional methods that may not provide personalized support or address specific community needs. ^{3 11 12 13 14}

Research Team

Poorna Kushalnagar

Principal Investigator

Gallaudet University

Eligibility Criteria

This trial is for deaf, deafblind, and hard of hearing individuals who have not been screened for cancer as recommended. Specific eligibility criteria are not provided.

Inclusion Criteria

Access to necessary resources to support video-based communication

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

Exclusion Criteria

I am up to date with all my recommended health screenings.

I am outside the age range for recommended cancer screenings.

Knows other participants at baseline

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

CHN provides educational sessions with patients to promote cancer screenings

9 months

Follow-up

Participants are monitored for adherence to cancer screening and changes in patient-physician communication

2 months

Treatment Details

Interventions

• Community Health Navigator Program

Trial Overview The trial is testing an educational program designed to encourage cancer screenings among the DDBHH community.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

CHN provides educational sessions with patients at time points.

Group II: Standard of Care Active Control 1 Intervention

Standard of care to inform participant about the screening recommendations and check ins.

Who Is Running the Clinical Trial?

Gallaudet University

Lead Sponsor

Trials

3

Recruited

250+

Findings from Research

Patient navigation (PN) significantly improves breast cancer screening completion rates, with an odds ratio of 2.0, indicating that those receiving navigation are twice as likely to complete screening compared to those who do not.

PN also reduces the time to diagnosis by an average of 9.9 days, enhancing the efficiency of the screening process, although it does not affect the resolution of abnormal test results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Patient Navigation on Population-Based Breast Screening: a Systematic Review and Meta-analysis of Randomized Clinical Trials. Tian, L., Huang, L., Liu, J., et al.[2023]

In a study involving 222 patients, those who received patient navigation (PN) for cancer screening reported significantly higher satisfaction with their overall medical care compared to those who did not receive PN (71.0 vs 66.8).

The results suggest that PN programs can enhance patient satisfaction, particularly for individuals at high risk of not adhering to recommended cancer screening, indicating a potential benefit for improving care quality and equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. Hermann, EA., Ashburner, JM., Atlas, SJ., et al.[2022]

Patient navigation interventions have shown some efficacy in increasing cancer screening participation by 10.8% to 17.1% and improving adherence to diagnostic follow-up care by 21% to 29.2% compared to control patients, based on a review of 16 studies.

However, there is limited evidence on the effectiveness of patient navigation in reducing late-stage cancer diagnoses or improving treatment initiation and survivorship outcomes, indicating a need for further research to assess their overall impact and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation: state of the art or is it science? Wells, KJ., Battaglia, TA., Dudley, DJ., et al.[2022]

The FDA's ASTER pilot study demonstrated that electronic health record (EHR)-triggered adverse event reports can provide valuable postmarketing safety information, particularly for known adverse drug events (ADEs).

However, the quality of the reports varied, with many lacking critical details such as informative descriptions and relevant laboratory data, highlighting the need for improved data quality to enhance the utility of EHR-triggered ADE reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. Brajovic, S., Piazza-Hepp, T., Swartz, L., et al.[2012]

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

A pharmacist-led program effectively managed adverse events in 123 patients with EGFR mutation-positive non-small cell lung cancer receiving afatinib, highlighting the importance of patient education and proactive monitoring in a community oncology setting.

Common adverse events included diarrhea (85%) and rash/skin reactions (58%), with 13% of patients discontinuing treatment due to these side effects; however, those who continued treatment often had dose reductions, indicating a strategy to maintain therapy despite adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist-led patient education and adverse event management in patients with non-small cell lung cancer receiving afatinib in a community-based, real-world clinical setting. Khrystolubova, N., Shieh, M., Patel, AJ., et al.[2020]

The FDA has initiated the Sentinel System to enhance the monitoring of adverse events related to medical products by utilizing electronic health care data, moving beyond traditional voluntary reporting methods.

The Federal Partners' Collaboration pilot project has demonstrated the ability to analyze large public health databases in near real time, allowing for more effective identification and assessment of specific patient populations and subgroups affected by medical products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active surveillance of postmarket medical product safety in the Federal Partners' Collaboration. Robb, MA., Racoosin, JA., Worrall, C., et al.[2019]

The study reviewed 27 articles on community health navigator (CHN) interventions for cancer screening, identifying two main models: community-based and clinic/hospital-based, each with distinct target populations and outreach strategies.

Both models of CHN interventions showed effective outcomes in promoting cancer screening, highlighting the importance of tailored approaches based on community needs and settings to address cancer disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on US-based community health navigator (CHN) interventions for cancer screening promotion--comparing community- versus clinic-based navigator models. Hou, SI., Roberson, K.[2021]

References

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

Impact of Patient Navigation on Population-Based Breast Screening: a Systematic Review and Meta-analysis of Randomized Clinical Trials. [2023]

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

Navigating Language Barriers: A Systematic Review of Patient Navigators' Impact on Cancer Screening for Limited English Proficient Patients. [2023]

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

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]

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

Lay patient navigator program implementation for equal access to cancer care and clinical trials: essential steps and initial challenges. [2022]

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

Patient navigation: state of the art or is it science? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration. [2012]

7. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Pharmacist-led patient education and adverse event management in patients with non-small cell lung cancer receiving afatinib in a community-based, real-world clinical setting. [2020]

9. Egypt pubmed.ncbi.nlm.nih.gov

Rates of minor adverse events and health resource utilization postcolonoscopy. [2019]

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

Active surveillance of postmarket medical product safety in the Federal Partners' Collaboration. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Comprehensive diagnostic program for medically underserved women with abnormal breast screening evaluations in an urban population. [2021]

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

What makes for successful patient navigation implementation in cancer prevention and screening programs using an evaluation and sustainability framework. [2022]

13. England pubmed.ncbi.nlm.nih.gov

A systematic review on US-based community health navigator (CHN) interventions for cancer screening promotion--comparing community- versus clinic-based navigator models. [2021]

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

Decreasing disparities in breast cancer screening in refugee women using culturally tailored patient navigation. [2021]