ICAN Health System Intervention for Rural Cancer Care Quality

Overseen By Mary Schroeder, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mary Charlton

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

Compensation: Varies

Number of Visits: Unknown

31 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to implement and evaluate the recently developed Iowa Cancer Affiliate Network (ICAN) intervention. The ICAN intervention will consist of members of the research team providing ongoing support to participating hospitals in achieving the quality standards outlined by the American College of Surgeons Commission on Cancer (CoC). Support will be offered in the form of education and training regarding the standards and provision of cancer services, regular in-person and zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation and educational resources regarding standard requirements. Implementation approach:1) Engage implementation teams and develop and execute implementation plans based on hospital needs assessments; and 2) Conduct interviews with key ICAN stakeholders to assess acceptability, adoption, appropriateness and cost (based on Proctor's implementation outcomes framework) and determinants of these outcomes (e.g., hospital structure, culture, resources, capacity, readiness) based on the Consolidated Framework for Implementation Research. Evaluation approach: Using Iowa Cancer Registry data routinely collected for surveillance purposes, the investigators will compare rates of compliance with pre- and post-intervention treatment-related quality measures in target and control hospitals. The rural hospitals in Iowa that serve the most rural cancer patients and have never been accredited by the CoC were chosen for intervention targets, and all committed to participating in the study (letters of support provided). The remainder of rural hospitals that care for \>100 newly diagnosed cancer patients per year (n=5) were chosen as a comparison group. The investigators will use data routinely collected by the Iowa Cancer Registry to compare aggregate compliance with quality measures for cancer care between the hospitals included in the intervention and comparison group hospitals using a difference-in-difference estimator. In addition, the investigators will conduct interviews with representatives from intervention hospitals to assess the extent to which ICAN hospitals implemented the CoC standards of cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the ICAN Health System Intervention for Rural Cancer Care Quality treatment?

The Rural Oncology Literacy Enhancement Study (ROLES) found that improving health literacy and patient navigation in rural areas can enhance cancer care and outcomes, suggesting that similar interventions like the ICAN Health System could be effective in addressing rural cancer care disparities. ^{1 2 3 4 5}

How is the ICAN Health System Intervention for Rural Cancer Care Quality different from other treatments?

The ICAN Health System Intervention is unique because it focuses on improving cancer care quality specifically in rural areas, addressing disparities in access to care and outcomes that are often seen in these regions. This approach is novel as it targets the systemic issues of healthcare delivery in rural settings rather than focusing solely on the medical treatment of cancer itself. ^{3 6 7 8 9}

Eligibility Criteria

This trial is for administrators, clinicians, and data monitoring staff involved in cancer care at one of the four selected hospitals. It aims to improve quality standards in rural hospitals that have not been accredited by the Commission on Cancer.

Inclusion Criteria

Administrators, clinicians, and data monitoring staff who help provide cancer related care at one of the four hospitals that have been included in our study.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the ICAN intervention, including education, training, and regular check-ins with hospital stakeholders

36 months

Regular in-person and virtual check-ins

Evaluation

Evaluation of compliance with CoC quality measures using Iowa Cancer Registry data

4 years

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Iowa Cancer Affiliate Network (ICAN)

Trial Overview The Iowa Cancer Affiliate Network (ICAN) intervention is being tested. It involves education, training, regular check-ins with hospital stakeholders via in-person and Zoom meetings, and resources to help meet American College of Surgeons' cancer care standards.

Participant Groups

Group I: Intervention Hospital Administrators, Providers, and Data Monitoring Staff Experimental Treatment 1 Intervention

This is a health-system-level intervention, designed as two-arm intervention trial, where four participating hospitals will be offered support in the areas of training and education, cancer data collection and reporting, quality improvement and clinical peer-to-peer support. Hospitals that are eligible for the intervention had to be located in an Iowa county classified as non-metropolitan according to rural urban continuum codes (RUCC) 4 through 9 and diagnose or treat at least 100 cancer patients each year. We selected 4 of the 9 rural hospitals meeting this criteria to administer the intervention.

Group II: Control arm Active Control 1 Intervention

Hospitals that are eligible for the intervention had to be located in an Iowa county classified as non-metropolitan according to rural urban continuum codes (RUCC) 4 through 9 and diagnose or treat at least 100 cancer patients each year. The remaining 5 hospitals meeting this criteria that were not selected for the intervention will serve as controls.

Who Is Running the Clinical Trial?

Mary Charlton

Lead Sponsor

Trials

1

Recruited

30+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The breast cancer nurse navigator (BCNN) program at the University of New Mexico Comprehensive Cancer Center significantly improved patient preparedness and engagement for treatment among 54 navigated patients compared to 32 non-navigated patients.

Patients who received navigation reported higher satisfaction with their care, as evidenced by a decreased desire for after-treatment summaries, suggesting that the BCNN program effectively addresses gaps in cancer care for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Measures of a Breast Cancer Nurse Navigator Program in an Underserved, Rural, and Economically Disadvantaged Patient Population. Williams, MA., Nielsen, DR., Dayao, Z., et al.[2022]

References

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

Cervical cancer care in rural Virginia: The impact of distance from an academic medical center on outcomes & the role of non-specialized radiation centers. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Identifying health literacy and health system navigation needs among rural cancer patients: findings from the Rural Oncology Literacy Enhancement Study (ROLES). [2021]

3. England pubmed.ncbi.nlm.nih.gov

Geographic differences in community oncology provider and practice location characteristics in the central United States. [2023]

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

Disparity of Colon Cancer Outcomes in Rural America: Making the Case to Travel the Extra Mile. [2020]

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

Patient-Reported Measures of a Breast Cancer Nurse Navigator Program in an Underserved, Rural, and Economically Disadvantaged Patient Population. [2022]

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

Organizational and Environmental Correlates to Preventive Quality of Care in US Rural Health Clinics. [2021]

7. Australia pubmed.ncbi.nlm.nih.gov

Exploring the impact of remoteness on people with head and neck cancer: Utilisation of a state-wide dataset. [2023]

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

Trends in medical oncology outreach clinics in rural areas. [2016]

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

Rural-Urban Disparities in Cancer Outcomes: Opportunities for Future Research. [2023]