Implementation of a Health System Intervention to Improve Quality of Cancer Care for Rural Patients

NCT05645328 | Active Not Recruiting

• 2 other identifiers: 202202104R01CA254628
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Health system intervention; Rural health; Quality improvement; Implementation science

Outcome Measures

Primary Outcomes (2)

• Compliance with CoC quality of cancer care measures: Hormone therapy (HT)

  primary quality measure for breast cancer: percent of patients receiving tamoxifen or 3rd gen aromatase inhibitor within 1 year of diagnosis for women with T1cN0M0 or stage IB-III hormone receptor-positive cancer

  36 months post implementation of intervention

• Compliance with CoC quality of cancer care measures: 12 regional lymph nodes (12RLN)

  primary quality measure for colon cancer: percent of patients having \>12 regional lymph nodes removed and examined

  36 months post implementation of intervention

Secondary Outcomes (4)

• Compliance with CoC quality of cancer care measures: Breast conserving surgery radiation therapy (BCSRT)

  36 months post implementation of intervention

• Compliance with CoC quality of cancer care measures: Multi-agent chemotherapy (MAC)

  36 months post implementation of intervention

• Compliance with CoC quality of cancer care measures: Adjuvant chemotherapy (ACT)

  36 months post implementation of intervention

• Percentage of CoC evidence-based standards of cancer care implemented

  36 months post implementation of intervention

Study Arms (2)

Intervention Hospital Administrators, Providers, and Data Monitoring Staff

EXPERIMENTAL

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.

Other: Iowa Cancer Affiliate Network (ICAN)

Control arm

NO 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.

Interventions

Iowa Cancer Affiliate Network (ICAN) OTHER

Each hospital in the intervention has undergone interviews in which the investigators elicited program goals, challenges, and readiness for change. Prior to the intervention, the cancer centers will be provided a document specifying current status for meeting Commission on Cancer (CoC) accreditation standards, gaps identified, suggestions and resources for the next steps to meet goals, and progress toward fulfilling CoC accreditation standards. The hospitals will be offered support, expertise, and resources to facilitate them in achieving the CoC standards. Support will be offered in the form of education/training regarding the standards and provision of cancer services, regular in-person/zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation/educational resources regarding standard requirements. The intervention actions will be tailored to the needs of each hospital based on standards they currently do not meet and choose to work toward.

Intervention Hospital Administrators, Providers, and Data Monitoring Staff

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Mary Charlton: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52240, United States

Location

Related Publications (1)

• Schroeder MC, Birken SA, Lizarraga IM, Kirk MA, Wagi CR, Engelbart JM, Johnson EC, Wahlen MM, Seaman AT, Charlton ME. Application of MODIFI to the adaptation of a complex, multilevel intervention to enhance access to high-quality cancer services in rural cancer hospitals. Implement Sci Commun. 2025 Oct 16;6(1):105. doi: 10.1186/s43058-025-00805-x.

  PMID: 41102855 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: January 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)