Clinical trial NCT05978232: NAVAH Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients
Official title: Prospective Pilot Study of Navigator-Assisted Hypofractionation (NAVAH) Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Keywords: Radiation Therapy
Navigator-Assisted Hypofractionation
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
name: Gilead Sciences
name: University Hospitals Cleveland Medical Center
First posted: 2023-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of barriers to navigator access
timeFrame: Immediately following radiotherapy treatment
Secondary outcomes:
measure: Assess the impact of patient navigation on patient access to radiation oncology care
timeFrame: Immediately following radiotherapy treatment
measure: Minority financial toxicity differences
timeFrame: Immediately following radiotherapy treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center Seidman Cancer Center
name: Shearwood McClelland III, MD
role: PRINCIPAL_INVESTIGATOR
References: