Clinical trial NCT01954641: Accountability for Cancer Care Through Undoing Racism and Equity
Official title: Accountability for Cancer Care Through Undoing Racism and Equity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Keywords: breast cancer
lung cancer
cancer treatments
racial inequity
health systems change
transparency
accountability
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Partnership Project, Inc.
name: Cone Health System Cancer Center
name: University of Pittsburgh
name: North Carolina Translational and Clinical Sciences Institute
First posted: 2013-10-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Purpose: African American cancer patients, as compared to their White counterparts, continue to initiate treatment later and remain less apt to undergo complete treatment; fueling worse treatment outcomes including shorter survival. The concepts of "transparency" and "accountability," as mechanisms of systems change have been applied for decades by anti-racism organizations to civil rights and social change. Yet, the application of these concepts to health systems' change and unequal treatment has rarely been done. The Greensboro Health Disparities Collaborative and two Cancer Centers have joined together to specify structures built into cancer care systems that make cancer care vulnerable to institutional racism and investigate how they can be changed to reduce racial inequity in quality and completion of treatment for Stage 1-2 breast and lung cancer patients.

Participants: White and African American patients with first diagnosis of Stage 1-2 breast and lung cancer, with intention to treat, and their cancer care staff at 2 cancer centers. The 2 cancer centers are Cone Health Cancer Center (CHCC) in Greensboro, North Carolina and the University of Pittsburgh Medical Center (UPMC) Hillman Comprehensive Cancer Center in Pittsburgh, Pennsylvania.

Procedures (methods): Using a 5-year interrupted time-series, with an embedded randomized control trial (RCT) study design, we will test the effectiveness of the ACCURE intervention components. Having received Institutional Review Board approval for Phase 1, we completed a 5-year, retrospective review of de-identified Electronic Medical Record data to establish a baseline of repeated outcome measures, convening of an expert committee to design the intervention, and design of the real-time, electronic breast and lung cancer registry coupled with dummy testing of the registry system.

The randomized trial will compare patients who receive usual care to those who receive visits and calls from a trained ACCURE Navigator, who is well versed in issues specific to breast and lung cancer and trained to serve as a two-way communication bridge to optimize the cancer care system's accountability and transparency for equity in quality of care. Given unintended, but likely variation in implementation of the ACCURE intervention by the two Cancer Centers (at our two research sites), 6 elements of implementation and their potential effect on outcomes will be documented through a process evaluation.

Detailed description: The ACCURE Interventions include:

1. Quality Improvement / Race specific feedback for providers regarding breast and lung surgery and adjuvant treatments.
2. A real time registry with automated electronic health record feeds that provides warning signs if milestones in cancer care have not been met or if patients miss scheduled appointments
3. Health Equity Training for cancer center staff at quarterly intervals
4. Accure Navigation (based on special training regarding trust, culturally appropriate communication, and Kleinman's Patient Model of Illness)
5. Additional efforts will be made to collect information on symptoms and side effect management from patients and medical charts.

Eligibility criteria: Inclusion Criteria:

* White or African American patients aged 18 or older
* Recently received a first diagnosis of stage 1 or 2 breast or lung cancer
* Patient plans to initiate oncology treatment with curative intent

Exclusion Criteria:

* Have cognitive impairments or limited English proficiency that would preclude their ability to comprehend survey questions

Primary outcomes:
measure: Lung Cancer - Lung Resection Surgery within 4 months of diagnosis or stereotactic radiation Breast Cancer - Completion of surgery, radiation if surgery is breast conserving, and adjuvant chemotherapy (when indicated) within 6 months of diagnosis
timeFrame: Chart review 6 to 8 months after patient enrollment and continuous Electronic Health Record (EHR) downloads into the real time registry for the 3 years of follow up.
Secondary outcomes:
measure: Adherence to scheduled appointments
timeFrame: Continuous downloads of Electronic Health Record (EHR) data into the real time registry for the 3 years of follow up or death or study withdrawal - whichever comes first.
Other outcomes:
measure: Patient satisfaction with communication
timeFrame: Will be assessed by survey every 6 months for 3 years post enrollment or until death or study withdrawal, whichever comes first.
measure: Trust
timeFrame: Will be assessed by survey every 6 months for 3 years post enrollment or until death or study withdrawal, whichever comes first.
measure: Functional Status
timeFrame: Will be assessed by survey every 3 months in year one then every 6 months in years 2 and 3 or until death or study withdrawal, whichever comes first.
Locations:
city: Greensboro
country: United States
facility: Cone Health, Regional Cancer Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Hillman Comprehensive Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Eugenia Eng, MPH, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Samuel Cykert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cykert S, Eng E, Walker P, Manning MA, Robertson LB, Arya R, Jones NS, Heron DE. A system-based intervention to reduce Black-White disparities in the treatment of early stage lung cancer: A pragmatic trial at five cancer centers. Cancer Med. 2019 Mar;8(3):1095-1102. doi: 10.1002/cam4.2005. Epub 2019 Feb 4.