Impact of Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer
| Registry | NCT07014618 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 420 (Estimated) |
| Sponsor | University of Oklahoma (Other); collaborators: Gilead Sciences, Radiation Therapy Oncology Group, Susan G. Komen Breast Cancer Foundation |
| Conditions | Breast Cancer, Prostate Cancer |
| Interventions | Pre & Post Surveys, Opt Out of Questionnaire (Other) |
| Dates | start 2025-10-16, primary completion 2029-10-01 (estimated), completion 2030-10-01 (estimated), first posted 2025-06-11, last updated 2025-12-17 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Breast Cancer All trials for Prostate Cancer All trials of Pre & Post Surveys All trials of Opt Out of Questionnaire
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Consented to Study | Other: Pre & Post Surveys; Other: Opt Out of Questionnaire | 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. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| OU Health Stephenson Cancer Center | Oklahoma City, Oklahoma | United States | Recruiting |