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| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
| Gilead Sciences | INDUSTRY |
| University Hospitals Cleveland Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigator-Assisted Hypofractionation (NAVAH) | Experimental | This pilot cohort study is designed as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAVAH | Behavioral | Patient navigator program that aims to inform African-American prostate and breast cancer patients about their treatment options, specifically radiotherapy |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shearwood McClelland III, MD | University Hospitals Cleveland Medical Center Seidman Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41091946 | Derived | 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. 2026 Mar 1;49(3):125-126. doi: 10.1097/COC.0000000000001257. Epub 2025 Oct 15. | |
| 40525892 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 |
| Posani S, Burnette UJ, McClelland S 3rd. Quantification of Postdiagnosis Cancer Patient Navigation. Am J Clin Oncol. 2025 Dec 1;48(12):610-613. doi: 10.1097/COC.0000000000001225. Epub 2025 Jun 17. |
| 40025854 | Derived | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |