Clinical trial NCT07014618: Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer
Official title: Impact of Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Prostate Cancer
Keywords: Native American (NA)
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: Radiation Therapy Oncology Group
name: Susan G. Komen Breast Cancer Foundation
First posted: 2025-06-11
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from underrepresented minority populations (African American, Native American, and Hispanic/Latino) are eligible to be screened for the study regardless of gender. Patients must meet the inclusion criteria before consenting to the trial.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Patients Who Complete Radiation Therapy
timeFrame: 6 months
Secondary outcomes:
measure: Number of Patients Successfully Impacted by Patient Navigation on Radiation Therapy
timeFrame: 6 Months
measure: Investigate The Differences in Financial Toxicity Levels
timeFrame: 6 Months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: OU Health Stephenson Cancer Center
name: Shearwood McClelland III, MD
role: PRINCIPAL_INVESTIGATOR
References: