Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer

Not yet recruiting

• Conditions: Breast Cancer; Prostate Cancer

• Registration Number: NCT07014618
• Lead Sponsor: University of Oklahoma

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 Timeline

• Study First Submitted: 2025-05-13
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Study Start: 2025-07
• Primary Completion: 2029-07
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Complete Radiation Therapy	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 Outcome Measures

Name	Time	Method
Number of Patients Successfully Impacted by Patient Navigation on Radiation Therapy	6 Months	Assess the impact of patient navigation on patient access to radiation oncology care \[Time Frame: Immediately following radiotherapy treatment\]; Qualitative mechanisms will be used to assess the impact of patient navigation on patient access to radiation oncology care and consequently utilization of standard of care modalities. This study will use patient-completed surveys to evaluate the impact of patient navigation on access to short-course RT by using a culturally sensitive survey adapted from "Walking Forward", a patient navigator program providing culturally appropriate community education on cancer, screening and treatmen. The feedback provided by patients on the impact of patient navigation will be compared- before and after RT, and will also be compared against feedback from patients who did not received patient navigation.
Investigate The Differences in Financial Toxicity Levels	6 Months	This study will use patient-completed surveys to evaluate the impact of financial hardship in African-American breast cancer patients. Patient scores from an evidence-based tool, "The COmprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)" will be used to compare financial hardship in each group of patients with early-stage breast cancer who have received a lumpectomy. Surveys will investigate differences in financial toxicity survery scores experienced by underrepresented minorities receiving conventional versus short-course RT.

Trial Locations

Locations (1)

OU Health Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States