Accountability for Cancer Care Through Undoing Racism and Equity

NCT ID: NCT01954641

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ACCURE Navigator

For those patients assigned to the ACCURE Navigator, the ACCURE Real-Time Registry is programmed to automatically alert the Navigator when a patient misses a scheduled treatment appointment and to require the Navigator to include details as to how she addressed and resolved that missed appointment, ensuring the ACCURE Navigator's proactive approach to addressing such issues. In addition, a warning message will be produced if no follow-up appointments or procedures are scheduled within 21 days of the index visit.

Group Type EXPERIMENTAL

ACCURE Navigator

Intervention Type OTHER

The ACCURE Real-Time Registry will automatically alert the ACCURE Navigator to follow a schedule of patient-interactions. The Navigator has been trained to employ the "teachback" method of patient education as appropriate per encounter. For instance: (1) initial face-to-face interaction, after the patient's first visit with the oncologist; (2) telephone call 3 business days after the initial visit; (3) contact the patient 10-21 days after the initial visit; and (4) after treatment has begun, contacting the patient every 8 weeks.It is projected that 50% of the staff will attend the Healthcare Equity Training (HET) and Booster Sessions.

Usual Care by Cancer Center Care Team

A list of registry warnings about all patients enrolled in the study will be delivered securely to a designated representative at the clinic.

Group Type ACTIVE_COMPARATOR

Usual Care by Cancer Center Care Team

Intervention Type OTHER

The Usual Care group will receive the support and care that is usually given to patients at their designated cancer center.

Interventions

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ACCURE Navigator

The ACCURE Real-Time Registry will automatically alert the ACCURE Navigator to follow a schedule of patient-interactions. The Navigator has been trained to employ the "teachback" method of patient education as appropriate per encounter. For instance: (1) initial face-to-face interaction, after the patient's first visit with the oncologist; (2) telephone call 3 business days after the initial visit; (3) contact the patient 10-21 days after the initial visit; and (4) after treatment has begun, contacting the patient every 8 weeks.It is projected that 50% of the staff will attend the Healthcare Equity Training (HET) and Booster Sessions.

Intervention Type OTHER

Usual Care by Cancer Center Care Team

The Usual Care group will receive the support and care that is usually given to patients at their designated cancer center.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Partnership Project, Inc.

OTHER

Sponsor Role collaborator

Cone Health System Cancer Center

UNKNOWN

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugenia Eng, MPH, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Samuel Cykert, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Cone Health, Regional Cancer Center

Greensboro, North Carolina, United States

Site Status

University of Pittsburgh Medical Center, Hillman Comprehensive Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30714689 (View on PubMed)

Related Links

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http://hpdp.unc.edu

University of North Carolina Center for Health Promotion and Disease Prevention

http://www.greensborohealth.org

Greensboro Health Disparities Collaborative

Other Identifiers

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5R01CA150980-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-1474

Identifier Type: -

Identifier Source: org_study_id

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