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

NCT05978232 | Completed DMC

• 1 other identifier: CASE1123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Prostate Cancer

Keywords

Radiation Therapy; Navigator-Assisted Hypofractionation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (1)

Navigator-Assisted Hypofractionation (NAVAH)

EXPERIMENTAL

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).

Behavioral: NAVAH

Interventions

NAVAH BEHAVIORAL

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

Navigator-Assisted Hypofractionation (NAVAH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Susan G. Komen Breast Cancer Foundation: collaborator
• Gilead Sciences: collaborator
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (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.

  PMID: 41091946 DERIVED

• 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.

  PMID: 40525892 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.

  PMID: 40025854 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Shearwood McClelland III, MD

  University Hospitals Cleveland Medical Center Seidman Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: August 7, 2023
• Study Start: July 1, 2023
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)