Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01954641
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase N/A
Start date April 2013
Completion date March 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A