Impact of Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Oklahoma
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- Number of Patients Who Complete Radiation Therapy
Study Overview
Brief Summary
The purpose of this clinical trial is to evaluate radiation therapy (RT) completion rates among underrepresented cancer populations using qualitative measurements. Additionally, the study aims to assess the impact of patient navigators on supporting patients through their radiation care, as well as their influence on adherence to standard of care treatment modalities.
Detailed Description
The study aims to utilize qualitative measurements, including pre- and post-treatment breast and prostate cancer surveys tailored to specific ethnic groups-Native American, African American, and Hispanic/Latino populations. In addition to these culturally relevant surveys, participants will also complete the COST-Functional Assessment of Chronic Illness Therapy (COST-FACT) score to evaluate the financial and functional impact of their cancer care experience.
Those who choose to complete the surveys will be offered navigation assistance as part of the study intervention.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Number of Patients Who Complete Radiation Therapy
Time Frame: 6 months
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.
Secondary Outcomes
- Number of Patients Successfully Impacted by Patient Navigation on Radiation Therapy(6 Months)
- Investigate The Differences in Financial Toxicity Levels(6 Months)