Accountability for Cancer Care Through Undoing Racism and Equity

NCT01954641 | Completed

• 2 other identifiers: 11-14745R01CA150980-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Lung Cancer

Keywords

breast cancer; lung cancer; cancer treatments; racial inequity; health systems change; transparency; accountability

Outcome Measures

Primary Outcomes (1)

• 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).

  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 (1)

• Adherence to scheduled appointments

  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 (3)

• Patient satisfaction with communication

  Will be assessed by survey every 6 months for 3 years post enrollment or until death or study withdrawal, whichever comes first.

• Trust

  Will be assessed by survey every 6 months for 3 years post enrollment or until death or study withdrawal, whichever comes first.

• Functional Status

  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.

Study Arms (2)

ACCURE Navigator

EXPERIMENTAL

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.

Other: ACCURE Navigator

Usual Care by Cancer Center Care Team

ACTIVE COMPARATOR

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

Other: Usual Care by Cancer Center Care Team

Interventions

ACCURE Navigator 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.

ACCURE Navigator

Usual Care by Cancer Center Care Team OTHER

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

Usual Care by Cancer Center Care Team

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Cancer Institute (NCI): collaborator
• Partnership Project, Inc.: collaborator
• Cone Health System Cancer Center: collaborator
• University of Pittsburgh: collaborator
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (2)

Cone Health, Regional Cancer Center

Greensboro, North Carolina, 27401, United States

Location

University of Pittsburgh Medical Center, Hillman Comprehensive Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• 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.

  PMID: 30714689 DERIVED

Related Links

• University of North Carolina Center for Health Promotion and Disease Prevention
• Greensboro Health Disparities Collaborative

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eugenia Eng, MPH, DrPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Samuel Cykert, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: October 7, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)