NAVAH Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients

Prospective Pilot Study of Navigator-Assisted Hypofractionation (NAVAH) Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients

African-Americans have disparately limited access to optimal cancer care. They have the highest overall cancer death rate and shortest survival time of any racial or ethnic group in the United States. Elucidation of disparities in access to cancer care are important since previous work has indicated that when equal access to RT in Radiation Therapy Oncology Group (RTOG) prospective randomized trials is granted, race does not independently affect outcomes, a finding similar to work conducted in Level I evidence-proven optimal management of curable neurologic conditions. Breast cancer is the most common cancer in African-American women and Prostate cancer is the most common cancer in African-American men. African-American breast & prostate cancer participants are less likely to receive standard-of-care radiation therapy.

Previous work has identified that compared to Caucasian women with breast cancer, African-American women are 48% more likely to have RT omission during treatment, 167% less likely to receive timely completion of RT after breast-conserving surgery, 40% less likely to complete RT, and significantly more likely to experience RT treatment delays. Shorter course radiation therapy may reduce disparities in radiation therapy care facing African-American breast cancer participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Prostate Cancer
• Intervention / Treatment: Behavioral: NAVAH

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shearwood McClelland III, MD; Phone Number: 216-702-8700; Email: Shearwood.mcclelland@uhhospitals.org
• Study Contact Backup: Name: Shearwood McClelland III, MD; Email: drwood@post.harvard.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
      • Contact: Shearwood McClelland III, MD; Phone Number: 216-702-8700; Email: Shearwood.mcclelland@uhhospitals.org
      • Principal Investigator: Shearwood McClelland III, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects must have histologically or cytologically confirmed Breast or Prostate Cancer.
• Subjects must be Age >18 years. This study requires informed consent by the subject; as children are not able to perform this without parental approval, subjects < age 18 are excluded from this study.
• Subjects must be of African - American race.
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Subjects NOT of African - American ethnicity.
• Subjects WITHOUT histologically or cytologically confirmed Breast or Prostate Cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Navigator-Assisted Hypofractionation (NAVAH); This pilot cohort study is designed as follows: Navigator discussion with patients prior to the start of radiation therapy simulation (15-30 minutes).; Navigator administration of survey with patients after completion of radiation therapy simulation but before the start of radiation therapy (30-45 minutes); Navigator administration of post-treatment survey and financial toxicity survey instrument after the completion of radiation therapy (60 minutes).

Behavioral: NAVAH; Patient navigator program that aims to inform African-American prostate and breast cancer patients about their treatment options, specifically radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of barriers to navigator access	Survey-based methods will be used to assess barriers facing under-represented minority cancer patient access to patient navigation. This study will use a patient-completed, culturally sensitive survey adapted from "Walking Forward," a patient navigator program providing culturally appropriate community education on cancer, screening and treatment, to include barriers to specific RT regimens, and concerns regarding transportation.	Immediately following radiotherapy treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the impact of patient navigation on patient access to radiation oncology care	Qualitative mechanisms will be used to assess the impact of patient navigation on patient access to radiation oncology care and consequently utilization of standard of care modalities. This study will use patient-completed surveys to evaluate the impact of patient navigation on access to short-course RT by using a culturally sensitive survey adapted from "Walking Forward", a patient navigator program providing culturally appropriate community education on cancer, screening and treatmen. The feedback provided by patients on the impact of patient navigation will be compared- before and after RT, and will also be compared against feedback from patients who did not received patient navigation.	Immediately following radiotherapy treatment
Minority financial toxicity differences	This study will use patient-completed surveys to evaluate the impact of financial hardship in African-American breast cancer patients. Patient scores from an evidence-based tool, "The COmprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)" will be used to compare financial hardship in each group of patients with early-stage breast cancer who have received a lumpectomy. Surveys will investigate differences in financial toxicity survery scores experienced by underrepresented minorities receiving conventional versus short-course RT.	Immediately following radiotherapy treatment

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: Gilead Sciences; University Hospitals Cleveland Medical Center; Susan G. Komen Breast Cancer Foundation
• Investigators: Principal Investigator: Shearwood McClelland III, MD, University Hospitals Cleveland Medical Center Seidman Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 11, 2028

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Radiation Therapy; Navigator-Assisted Hypofractionation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CASE1123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No