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Trial Title:
NAVAH Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients
NCT ID:
NCT05978232
Condition:
Breast Cancer
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Radiation Therapy
Navigator-Assisted Hypofractionation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
NAVAH
Description:
Patient navigator program that aims to inform African-American prostate and breast cancer
patients about their treatment options, specifically radiotherapy
Arm group label:
Navigator-Assisted Hypofractionation (NAVAH)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shearwood McClelland III, MD
Phone:
216-702-8700
Email:
Shearwood.mcclelland@uhhospitals.org
Investigator:
Last name:
Shearwood McClelland III, MD
Email:
Principal Investigator
Start date:
July 1, 2023
Completion date:
July 11, 2028
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Susan G. Komen Breast Cancer Foundation
Agency class:
Other
Collaborator:
Agency:
Gilead Sciences
Agency class:
Industry
Collaborator:
Agency:
University Hospitals Cleveland Medical Center
Agency class:
Other
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05978232
