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Accountability for Cancer Care Through Undoing Racism and Equity (ACCURE)

Primary Purpose

Breast Cancer, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACCURE Navigator
Usual Care by Cancer Center Care Team
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring breast cancer, lung cancer, cancer treatments, racial inequity, health systems change, transparency, accountability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cone Health, Regional Cancer Center
  • University of Pittsburgh Medical Center, Hillman Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACCURE Navigator

Usual Care by Cancer Center Care Team

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
Changes in race-specific proportions of quality and completion of breast and lung cancer treatment. Will examine the influence of Quality Improvement/race-specific feedback and the real time registry compared to historical controls using an interrupted time series analysis and will compare the ACCURE Navigator component to Usual Care control groups (the randomized portion of the study).

Secondary Outcome Measures

Adherence to scheduled appointments
Will count completed appointments over scheduled appointments and look at the influence that the ACCURE Navigator has on adherence throughout the study period

Full Information

First Posted
September 19, 2013
Last Updated
July 30, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Cancer Institute (NCI), Partnership Project, Inc., Cone Health System Cancer Center, University of Pittsburgh, North Carolina Translational and Clinical Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01954641
Brief Title
Accountability for Cancer Care Through Undoing Racism and Equity
Acronym
ACCURE
Official Title
Accountability for Cancer Care Through Undoing Racism and Equity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Cancer Institute (NCI), Partnership Project, Inc., Cone Health System Cancer Center, University of Pittsburgh, North Carolina Translational and Clinical Sciences Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Quality Improvement / Race specific feedback for providers regarding breast and lung surgery and adjuvant treatments. 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 Health Equity Training for cancer center staff at quarterly intervals Accure Navigation (based on special training regarding trust, culturally appropriate communication, and Kleinman's Patient Model of Illness) Additional efforts will be made to collect information on symptoms and side effect management from patients and medical charts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer
Keywords
breast cancer, lung cancer, cancer treatments, racial inequity, health systems change, transparency, accountability

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACCURE Navigator
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care by Cancer Center Care Team
Arm Type
Active Comparator
Arm Description
A list of registry warnings about all patients enrolled in the study will be delivered securely to a designated representative at the clinic.
Intervention Type
Other
Intervention Name(s)
ACCURE Navigator
Intervention Description
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
Intervention Name(s)
Usual Care by Cancer Center Care Team
Intervention Description
The Usual Care group will receive the support and care that is usually given to patients at their designated cancer center.
Primary Outcome Measure Information:
Title
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
Description
Changes in race-specific proportions of quality and completion of breast and lung cancer treatment. Will examine the influence of Quality Improvement/race-specific feedback and the real time registry compared to historical controls using an interrupted time series analysis and will compare the ACCURE Navigator component to Usual Care control groups (the randomized portion of the study).
Time Frame
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 Outcome Measure Information:
Title
Adherence to scheduled appointments
Description
Will count completed appointments over scheduled appointments and look at the influence that the ACCURE Navigator has on adherence throughout the study period
Time Frame
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 Pre-specified Outcome Measures:
Title
Patient satisfaction with communication
Description
Will examine the influence of the navigator on patient perceptions of communication
Time Frame
Will be assessed by survey every 6 months for 3 years post enrollment or until death or study withdrawal, whichever comes first.
Title
Trust
Description
Will examine the influence of the ACCURE navigator on measures of Trust of the provider and health care system
Time Frame
Will be assessed by survey every 6 months for 3 years post enrollment or until death or study withdrawal, whichever comes first.
Title
Functional Status
Description
Will assess functional status via survey and compare the various treatment modalities over time (as well as incomplete treatment).
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenia Eng, MPH, DrPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel Cykert, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cone Health, Regional Cancer Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
University of Pittsburgh Medical Center, Hillman Comprehensive Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30714689
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.
Results Reference
derived
Links:
URL
http://her.oxfordjournals.org/content/early/2013/08/31/her.cyt082.full?keytype=ref&ijkey=aR8qldHAdRCVYyA
Description
Critical incident technique: an innovative participatory approach to examine and document racial disparities in breast cancer healthcare services
URL
http://hpdp.unc.edu
Description
University of North Carolina Center for Health Promotion and Disease Prevention
URL
http://www.greensborohealth.org
Description
Greensboro Health Disparities Collaborative

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Accountability for Cancer Care Through Undoing Racism and Equity

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