Health Insurance Navigation for Colorectal Cancer Survivors

(HINT-C Trial)

No longer recruiting at 1 trial location

Overseen By Elyse Park, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Age, Psychiatric impairment, No internet, others

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

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help colorectal cancer survivors better understand and manage their health insurance. The main goal is to determine if the Health Insurance Navigation Program (HINT) improves insurance knowledge and reduces stress over medical bills. Participants will either receive help through five interactive sessions or a guidebook. Suitable candidates include English-speaking individuals who have recently undergone colon or rectal cancer treatment and have internet access. As an unphased trial, this study provides a unique opportunity to gain valuable support and insights into effective health insurance management.

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. It seems unlikely, as the trial focuses on health insurance literacy and financial burden, not on medication use.

What prior data suggests that the Health Insurance Navigation Program is safe for colorectal cancer survivors?

Research shows that programs designed to help people understand their health insurance are safe and well-liked by participants. Studies with colorectal cancer survivors have found these programs practical and welcomed. Participants valued the support in learning about their health insurance options.

No reports of negative effects have emerged from these programs, indicating they are easy to manage. The program primarily offers guidance and education through video calls, avoiding the risks associated with some medical treatments.

Overall, evidence suggests that this program is a safe choice for those seeking to better understand their health insurance and reduce financial stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health Insurance Navigation Program for colorectal cancer survivors because it offers a hands-on approach to managing health insurance, which is often a complex and stressful aspect of cancer recovery. Unlike standard resources that are typically self-service, this program provides personalized support through real-time videoconferencing with a trained patient navigator. This approach not only helps survivors understand their insurance better but also empowers them to make informed decisions, potentially improving their overall health outcomes.

What evidence suggests that the Health Insurance Navigation Program is effective for improving health insurance literacy and reducing financial distress for colorectal cancer survivors?

This trial will compare a Navigation Intervention with Enhanced Usual Care for colorectal cancer survivors. Research has shown that programs assisting individuals in understanding health insurance can ease the burden of medical costs for cancer survivors. One study found that participants in these programs gained a better understanding of their health insurance. Another study indicated that these programs can alleviate financial strain, helping patients manage medical expenses more effectively. Early findings suggest that trained helpers who communicate with patients via video calls can provide effective guidance, reducing financial stress. Overall, these programs appear to boost colorectal cancer survivors' confidence in managing their health insurance and related costs. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for colorectal cancer survivors aged 18-65, who are 12-24 months post-treatment for stages I-III of the disease. Participants must have visited MGH in the last two years, have health insurance and speak English. They also need access to a device with internet like an iPad, computer or smartphone.

Inclusion Criteria

Patients who had a medical visit at MGH in the past two years

Patients who have medical insurance

Patients who have access to an iPad, computer, smartphone, or laptop with WIFI access

Exclusion Criteria

Patients who lack access to a smartphone, computer, or tablet with internet access

Patients who do not currently have health insurance

I am unable to give consent due to mental health or cognitive issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Health Insurance Navigation Tools (HINT) intervention consisting of 5 weekly sessions delivered via videoconferencing

5 weeks

5 visits (virtual)

Follow-up

Participants are monitored for changes in health insurance literacy and financial burden

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Insurance Navigation Program
• Health Insurance Navigation Tools Program

Trial Overview The study is testing a Health Insurance Navigation Tools Program (HINT) designed to help colorectal survivors understand their health insurance better and reduce financial stress from medical costs. The program will be compared to standard information guides provided to a control group.

How Is the Trial Designed?

Group I: Navigation Intervention Experimental Treatment 1 Intervention

The intervention will be delivered via synchronous videoconferencing (real-time delivery and communication between the navigator and the participant) by a trained patient navigator and will consist of 5, 30-minute sessions delivered every week. The navigation intervention group will also receive an online or mailed copy of the health insurance resource guide.

Group II: Enhanced Usual Care Active Control 1 Intervention

Enhanced usual care will consist of an online or mailed health insurance resource guide.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

In a study of 438 cancer patients, patient navigation (PN) did not significantly improve overall treatment completion time, satisfaction with care, or psychological distress compared to usual care.

However, socially disadvantaged patients who received PN reported higher satisfaction with their care, indicating that PN may be beneficial for specific groups, despite no overall benefits observed in the primary analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for breast and colorectal cancer treatment: a randomized trial. Fiscella, K., Whitley, E., Hendren, S., et al.[2021]

The study characterized 8 patient navigation programs under the National Cancer Institute's ACCSIS initiative, highlighting their diverse socio-ecological contexts and implementation strategies for colorectal cancer screening and follow-up.

Most programs adapted existing evidence-based navigation methods, with some starting navigation at the initial screening stage and others at follow-up, indicating flexibility in addressing patient needs and enhancing participation in colorectal cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative. Coronado, GD., Ferrari, RM., Barnes, A., et al.[2023]

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]

The SEER program, which collects cancer data from about 30% of the U.S. population, is a crucial resource for understanding colorectal cancer and improving patient care.

The linked SEER-Medicare database enables research on health disparities, quality of care, and treatment costs, contributing to thousands of studies that have influenced colorectal cancer management since the 1970s.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surveillance, Epidemiology, and End Results (SEER) and SEER-Medicare Databases: Use in Clinical Research for Improving Colorectal Cancer Outcomes. Daly, MC., Paquette, IM.[2023]

A study of 150 colorectal cancer survivors found that only 36% adhered to recommended surveillance colonoscopy 13 months after surgery, with adherence significantly influenced by the type of health insurance coverage.

Participants with private or HMO health insurance were more likely to follow up with surveillance colonoscopy compared to those with other types of insurance, highlighting the need for targeted education and support to improve CRC surveillance adherence among diverse socioeconomic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Influencing Adherence to Recommended Colorectal Cancer Surveillance: Experiences and Behaviors of Colorectal Cancer Survivors. Ford, ME., Sterba, KR., Armeson, K., et al.[2022]

The CDC's National Program of Cancer Registries collects comprehensive cancer data on 96% of the U.S. population, which is crucial for understanding cancer incidence, treatment, and outcomes.

Recent advancements in cancer surveillance by the CDC enhance the ability to recruit participants for survivorship research and improve the sharing of treatment summaries, ultimately benefiting cancer survivors and their healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting the Dots: Linking the National Program of Cancer Registries and the Needs of Survivors and Clinicians. Ryerson, AB., Eheman, C., Styles, T., et al.[2019]

The Oncology Interactive Navigator™ (OIN) was found to be a valuable resource for 151 individuals newly diagnosed with colorectal cancer or melanoma, helping them access important cancer information and support during the critical early stages of their diagnosis.

Qualitative interviews with 20 participants revealed that the OIN™ significantly enhanced their understanding of cancer, improved communication with healthcare providers, and helped them prepare for medical consultations, indicating its potential as an effective tool for psychosocial adjustment in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual navigation in colorectal cancer and melanoma: an exploration of patients' views. Loiselle, CG., Peters, O., Haase, KR., et al.[2021]

The patient navigator program in New York City successfully increased adherence to screening colonoscopy among a diverse population, with an overall adherence rate of 84.2% among 37,077 adults aged 50 and older.

The program demonstrated feasibility for expansion across 10 hospital sites, effectively reducing ethnic disparities in screening rates, as adherence was similar among black (83.2%), Hispanic (84.9%), and white (87.5%) adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation and Impact on Adherence to Screening Colonoscopy in a Large Diverse Urban Population. Mendelsohn, RB., DeLeon, SF., Calo, D., et al.[2022]

Colorectal cancer screening is crucial for reducing mortality, yet only 58.6% of adults are up-to-date with screenings, highlighting a significant gap in preventive care.

Implementing patient navigation interventions can effectively increase adherence to colorectal cancer screening and help reduce health disparities, but requires careful design considering factors like community characteristics, navigator qualifications, and evaluation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key considerations in designing a patient navigation program for colorectal cancer screening. DeGroff, A., Coa, K., Morrissey, KG., et al.[2021]

The study reviewed 11 publications on patient navigation (PN) and patient activation (PA) interventions for cancer, highlighting that only six specifically focused on older patients, indicating a gap in targeted research for this demographic.

While the interventions showed varied impacts on older patients, there was limited focus on their quality of life, suggesting a need for more rigorous studies to better understand and tailor these interventions to improve outcomes for elderly cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation and activation interventions for elderly patients with cancer: A systematic review. van Ee, IB., Hagedoorn, M., Slaets, JP., et al.[2018]

The implementation of a patient navigation (PN) program at five hospitals significantly increased the rate of follow-up colonoscopies after abnormal fecal immunochemical testing (FIT), from 40.6% in 2017 to 46% in 2018, indicating improved patient adherence to necessary screenings.

The average time from an abnormal FIT result to colonoscopy decreased from 163 days in 2017 to 113 days in 2018, demonstrating that the PN program effectively expedited the follow-up process for patients aged 50-75.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the Gap: Patient Navigation Increases Colonoscopy Follow-up After Abnormal FIT. Idos, GE., Bonner, JD., Haghighat, S., et al.[2023]

Patient navigation (PN) improved initial colorectal cancer screening rates in underserved populations, but did not significantly increase the completion of follow-up screening colonoscopy (FSC) within the recommended six-month timeframe, with 53% of navigated patients completing FSC compared to 45% of unnavigated patients.

Despite the lack of a significant difference in overall completion rates, navigated patients showed higher odds of completing FSC when adjusted for factors like insurance and education, suggesting that PN may still have potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timeliness of Surveillance Colonoscopy in Underserved Populations: Association with Patient Navigation for Initial Screening Colonoscopy. Percac-Lima, S., Ashburner, JM., Enogieru, I., et al.[2021]

Citations

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Assessing the feasibility and preliminary effects of a health ... Assessing the feasibility and preliminary effects of a health insurance navigation intervention for colorectal cancer survivors. · Abstract.

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Virtual Health Insurance Navigation Pilot Program for ... The present study seeks to develop and pilot a health. insurance navigation program with adult colorectal cancer survivors recruited from MGH. Patients ...

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Project Details This proposal addresses the urgent need to improve YA cancer survivors' health insurance literacy and decrease financial toxicity, thus improving their ability ...

4. researchgate.net researchgate.net/publication/391685882_Assessing_the_effect_of_virtual_navigation_interventions_to_improve_health_insurance_literacy_and_decrease_financial_burden_in_cancer_survivors_The_HINT_II_study_protocol

Assessing the effect of virtual navigation interventions to ... Assessing the effect of virtual navigation interventions to improve health insurance literacy and decrease financial burden in cancer survivors: ...

5. discovery.researcher.life discovery.researcher.life/article/effectiveness-and-cost-of-implementing-a-patient-navigation-program-to-increase-colorectal-cancer-screening-in-a-large-federally-qualified-health-center/aa522bd0f535306ca4d83eb88275527b

Effectiveness and cost of implementing a patient navigation ... The purpose of this study was to evaluate the effectiveness and cost of a patient navigation (PN) program in a large federally qualified ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39291801/

Development of a Health Insurance Navigation Program for ... We describe how we followed the ORBIT model of intervention development to create Health Insurance Navigation Tools (HINT), a health insurance patient ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05527392

NCT05527392 | Virtual Health Insurance Navigation Pilot ... The present study seeks to evaluate a health insurance navigation program with childhood cancer survivors recruited from the Long-Term Follow-Up (LTFU) Cohort.

8. meetings.asco.org meetings.asco.org/abstracts-presentations/227496

Assessing the feasibility and preliminary effects of a health ... Assessing the feasibility and preliminary effects of a health insurance navigation intervention for colorectal cancer survivors. · Authors · Research Funding.

9. ccss.stjude.org ccss.stjude.org/content/dam/en_US/shared/ccss/documents/investigator-meetings/2022/9-park-health-insurance-report.pdf

A health insurance navigation intervention tool (HINT) for ... A targeted virtual health insurance navigation program is feasible and acceptable. • Our findings indicate that a navigation program can improve ...