NAVAH Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients
NCT ID: NCT05978232
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-07-01
2025-11-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Navigator-Assisted Hypofractionation (NAVAH)
This pilot cohort study is designed as follows:
1. Navigator discussion with patients prior to the start of radiation therapy simulation (15-30 minutes).
2. Navigator administration of survey with patients after completion of radiation therapy simulation but before the start of radiation therapy (30-45 minutes)
3. Navigator administration of post-treatment survey and financial toxicity survey instrument after the completion of radiation therapy (60 minutes).
NAVAH
Patient navigator program that aims to inform African-American prostate and breast cancer patients about their treatment options, specifically radiotherapy
Interventions
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NAVAH
Patient navigator program that aims to inform African-American prostate and breast cancer patients about their treatment options, specifically radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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 WITHOUT histologically or cytologically confirmed Breast or Prostate Cancer.
18 Years
ALL
No
Sponsors
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Susan G. Komen Breast Cancer Foundation
OTHER
Gilead Sciences
INDUSTRY
University Hospitals Cleveland Medical Center
OTHER
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Shearwood McClelland III, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center Seidman Cancer Center
Locations
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University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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References
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Davis KJ, Burnette UJ, Sun Y, Stephens MJ, Onyewadume L, McClelland S 3rd. Medical Racism and Physician Trust Impressions of African-American Breast Cancer Patients Enrolled on the Navigator-Assisted Hypofractionation (NAVAH) Phase I Clinical Trial. Am J Clin Oncol. 2025 Jul 1;48(7):339-341. doi: 10.1097/COC.0000000000001183. Epub 2025 Mar 3.
McClelland S 3rd, Burnette U, Onyewadume L, Smith TK, Speers CW. Impact of Patient Navigation on Radiation Therapy Completion in Black Breast Cancer Patients: Early Phase I Trial Results From the Navigator-Assisted Hypofractionation (NAVAH) Program. Am J Clin Oncol. 2025 Oct 15. doi: 10.1097/COC.0000000000001257. Online ahead of print.
Posani S, Burnette UJ, McClelland S 3rd. Quantification of Postdiagnosis Cancer Patient Navigation. Am J Clin Oncol. 2025 Jun 17. doi: 10.1097/COC.0000000000001225. Online ahead of print.
Other Identifiers
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CASE1123
Identifier Type: -
Identifier Source: org_study_id
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