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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05978232
Enrollment
30
Registered
2023-08-07
Start date
2023-07-01
Completion date
2025-11-03
Last updated
2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Prostate Cancer

Keywords

Radiation Therapy, Navigator-Assisted Hypofractionation

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.

Interventions

BEHAVIORALNAVAH

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

Sponsors

Susan G. Komen Breast Cancer Foundation
CollaboratorOTHER
Gilead Sciences
CollaboratorINDUSTRY
University Hospitals Cleveland Medical Center
CollaboratorOTHER
Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of barriers to navigator accessImmediately following radiotherapy treatmentSurvey-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

MeasureTime frameDescription
Assess the impact of patient navigation on patient access to radiation oncology careImmediately following radiotherapy treatmentQualitative 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.
Minority financial toxicity differencesImmediately following radiotherapy treatmentThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026