Education Program to Promote Cancer Screenings

Enrolling by invitation at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to encourage cancer screenings among people who are deaf, deafblind, or hard of hearing and have not had screenings as recommended. Researchers are testing whether a Community Health Navigator Program, an educational initiative, can improve screening rates through educational sessions. The trial compares this program to usual care, where participants receive standard information about screening recommendations. Ideal candidates are those with early hearing loss who use American Sign Language and have missed necessary cancer screenings, such as breast, lung, or colon, in the past year. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance healthcare accessibility for the deaf and hard of hearing community.

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 prior data suggests that this program is safe?

Research shows that programs using Community Health Navigators (CHNs) effectively encourage cancer screenings. These programs have increased the frequency and speed of screenings for breast, cervical, and colorectal cancers, particularly in community health centers.

Studies confirm that these programs do not involve direct medical treatments, resulting in no known side effects. They focus on educating and supporting individuals to complete necessary cancer screenings, ensuring participants face no physical risk from the program itself. Overall, the Community Health Navigator Program is safe and well-received by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Health Navigator (CHN) Program because it offers a personalized approach to promoting cancer screenings. Unlike the standard of care, which typically involves general information and recommendations, the CHN Program provides tailored educational sessions directly to patients. This direct engagement can help address individual concerns and barriers, potentially increasing screening rates and early cancer detection. By empowering patients with knowledge and support, the CHN Program aims to improve health outcomes in a more proactive and individualized manner.

What evidence suggests that the Community Health Navigator Program is effective for promoting cancer screenings?

This trial will compare the Community Health Navigator Program to standard care. Studies have shown that the Community Health Navigator Program effectively increases cancer screening rates. Research indicates that patient navigation, which helps patients navigate the healthcare system, boosts participation in screenings for breast, cervical, and colorectal cancers. These programs have been particularly successful in expediting screenings and increasing completion rates. Previous findings suggest that professional navigators lead to better outcomes in cancer screening efforts. This approach shows promise for improving screening among the deaf, deafblind, and hard of hearing communities. ^{4 5 6 7 8}

Who Is on the Research Team?

Poorna Kushalnagar

Principal Investigator

Gallaudet University

Are You a Good Fit for This Trial?

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

Willingness to adhere to the CHN clinical trial regimen

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Navigator Program

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

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7573022/

Effectiveness of Patient Navigation to Increase Cancer ... This study evaluates the effectiveness of patient navigation to increase screening for colorectal, breast, and cervical cancer in populations adversely ...

2. 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 ...

3. jons-online.com jons-online.com/issues/2017/july-2017-vol-8-no-7/1648-patient-navigation-effectiveness

Patient Navigation Effectiveness on Improving Cancer ... Discussion: The results suggest that PN is an effective intervention for increasing cancer screening, with greater effects achieved by professional navigators.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5586005/

Use of Community Health Workers and Patient Navigators ... Our findings support the effectiveness of CHW/PN programs to improve completion and timeliness of breast, cervical, and colorectal cancer screening in FQHCs.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0091743519303342

Patient navigator reported patient barriers and delivered ... Of the 437 responding PNs, 410 (94%) reported providing navigation for BCC and 172 (39%) reported providing navigation for CRC. There were 145 PNs (33%) who ...

6. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=24355707

Community Cancer Screening Program (CCSP) Designed to increase colorectal cancer screening among low-income adults, this intervention uses health navigators to identify patients due for screening.

7. cdc.gov cdc.gov/cancer/php/interventions/patient-navigation.html

Patient Navigation | Cancer The Community Preventive Services Task Force recommends patient navigation for breast, cervical, and colorectal cancer screening. Overview.

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34058

What makes for successful patient navigation implementation ... Integrating patient navigation into cancer prevention and early detection efforts has been effective in increasing cancer screening rates for the medically ...