Navigator-supported shorter-course radiation for breast and prostate cancer patients
Impact of Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer
This project will see if offering patient navigators and culturally tailored surveys helps African American, Native American, and Hispanic/Latino patients with breast or prostate cancer finish their radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT07014618 on ClinicalTrials.gov |
What this trial studies
This observational study tracks radiation therapy completion among African American, Native American, and Hispanic/Latino patients with breast or prostate cancer. Participants complete culturally tailored pre- and post-treatment surveys and the COST-Functional Assessment of Chronic Illness Therapy (COST-FACT) to capture financial and functional impacts. Those who complete the surveys are offered patient navigation support, and researchers will use qualitative measures to understand how navigation influences adherence to standard-of-care radiation regimens, including hypofractionation. Study activities are conducted at OU Health Stephenson Cancer Center and focus on identifying barriers and facilitators to completing radiation therapy.
Who should consider this trial
Good fit: Adults (18+) with histologically or cytologically confirmed breast or prostate cancer who self-identify as African American, Native American, or Hispanic/Latino and are scheduled for radiation therapy are ideal candidates.
Not a fit: People who are not African American, Native American, or Hispanic/Latino, who do not have breast or prostate cancer, who are under 18, or who are not receiving radiation therapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could increase radiation completion rates and reduce cultural, financial, and logistical barriers for underrepresented patients.
How similar studies have performed: Previous research shows patient navigation and culturally tailored support can improve adherence and completion of cancer treatments in underserved populations, though specific evidence focused on radiation hypofractionation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must have histologically or cytologically confirmed Breast or Prostate Cancer. * Subjects must be 18 years of age or older. This study requires informed consent by the subject. * Subjects must be of African American race, Native American race, or Hispanic ethnicity. * Subjects scheduled to undergo RT for Cancer Treatment. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Subjects NOT of African American race, Native American race or Hispanic ethnicity. * Subjects WITHOUT histologically/cytologically confirmed Breast or Prostate Cancer. * Subjects younger than 18 years old.
Where this trial is running
Oklahoma City, Oklahoma
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Shearwood McClelland III, MD — OU Health Stephenson Cancer Center
- Study coordinator: Lead Onco Nurse
- Email: SCC-IIT-Office@ouhsc.edu
- Phone: 405-271-8777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.