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

University of Oklahoma (OU)

Status: Enrolling

Conditions: Breast Cancer; Prostate Cancer

Treatments: Other: Opt Out of Questionnaire; Other: Pre & Post Surveys

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT07014618

OU-SCC-NAVAH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

420 participants in 1 patient group

Consented to Study

Description:

Participants in this study may provide consent in one of three ways. Consent to participate automatically includes authorization for chart review. The most comprehensive level of consent includes participation in both pre- and post-treatment surveys and receipt of navigation services as part of the study's support interventions. Another level includes consent for chart review and survey completion but a declination of navigation services. Lastly, some participants consent only to chart review and decline participation in the surveys, which automatically excludes them from receiving navigation services.

Treatment:

Other: Pre & Post Surveys

Other: Opt Out of Questionnaire