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

Case Comprehensive Cancer Center (Case CCC)

Status: Enrolling

Conditions: Breast Cancer; Prostate Cancer

Treatments: Behavioral: NAVAH

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05978232

CASE1123

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Navigator-Assisted Hypofractionation (NAVAH)

Experimental group

Description:

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).

Treatment:

Behavioral: NAVAH