Skip to main content
Clinical Trials/NCT05978232
NCT05978232
Completed
Not Applicable

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

Case Comprehensive Cancer Center1 site in 1 country30 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Case Comprehensive Cancer Center
Enrollment
30
Locations
1
Primary Endpoint
Evaluation of barriers to navigator access
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
November 3, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Evaluation of barriers to navigator access

Time Frame: Immediately following radiotherapy treatment

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.

Secondary Outcomes

  • Assess the impact of patient navigation on patient access to radiation oncology care(Immediately following radiotherapy treatment)
  • Minority financial toxicity differences(Immediately following radiotherapy treatment)

Study Sites (1)

Loading locations...

Similar Trials