Health Insurance Navigation for Colorectal Cancer Survivors

(HINT-C Trial)

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: Unknown

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to assess the feasibility and acceptability of colorectal survivors approached and engaged in HINT and aims to assess the preliminary efficacy of HINT to improve 1) health insurance literacy and 2) financial burden related to medical cost concerns colorectal survivors. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the HINT intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.

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 data supports the idea that Health Insurance Navigation for Colorectal Cancer Survivors is an effective treatment?

The available research shows that patient navigation programs, which are similar to Health Insurance Navigation, have been effective in increasing follow-up colonoscopy rates after abnormal tests. For example, one study found that patient navigation improved colonoscopy completion rates in both private and public healthcare settings. Another study indicated that patient navigation helped improve the timeliness of follow-up colonoscopies in underserved populations. These findings suggest that Health Insurance Navigation could be effective in helping colorectal cancer survivors manage their care and follow-up procedures. ^{1 2 3 4 5}

What safety data exists for the Health Insurance Navigation treatment?

The provided research does not directly address safety data for the Health Insurance Navigation treatment or its variants. The studies focus on patient navigation programs, cancer registries, and virtual navigation tools, but none specifically evaluate the safety of the Health Insurance Navigation treatment. ^{3 6 7 8 9}

Is the Health Insurance Navigation Program a promising treatment for colorectal cancer survivors?

Yes, the Health Insurance Navigation Program is promising because it helps colorectal cancer survivors better manage their health insurance, which can improve their access to necessary follow-up care and screenings. This can lead to better health outcomes by ensuring they receive timely and appropriate medical attention. ^{3 7 10 11 12}

Eligibility Criteria

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

I am between 18 and 65 years old.

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 younger than 18 or older than 65.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Patient navigation and activation interventions for elderly patients with cancer: A systematic review. [2018]

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

Patient navigation for breast and colorectal cancer treatment: a randomized trial. [2021]

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

Characteristics of patient navigation programs in the Cancer Moonshot ACCSIS colorectal cancer screening initiative. [2023]

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

Bridging the Gap: Patient Navigation Increases Colonoscopy Follow-up After Abnormal FIT. [2023]

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

Timeliness of Surveillance Colonoscopy in Underserved Populations: Association with Patient Navigation for Initial Screening Colonoscopy. [2021]

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

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

7. Germany pubmed.ncbi.nlm.nih.gov

Virtual navigation in colorectal cancer and melanoma: an exploration of patients' views. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Connecting the Dots: Linking the National Program of Cancer Registries and the Needs of Survivors and Clinicians. [2019]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Factors Influencing Adherence to Recommended Colorectal Cancer Surveillance: Experiences and Behaviors of Colorectal Cancer Survivors. [2022]

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

Key considerations in designing a patient navigation program for colorectal cancer screening. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation and Impact on Adherence to Screening Colonoscopy in a Large Diverse Urban Population. [2022]