Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
420Conditions
Breast Cancer, Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Shearwood McClelland III, MD
- 405-271-3016
- [email protected]
Principal Investigator
- Shearwood McClelland III, MD
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.
Study Plan
Consented to Study
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.
OTHER:
Pre & Post SurveysDescription:
As part of this intervention, patients will complete a pre-treatment questionnaire at the time of consent, which can be administered in person, over the phone, or through the mHealth mobile app, based on their preference. One month after treatment, patients will complete a post-treatment questionnaire using their chosen method. At the six-month mark, patients will complete an additional post-treatment questionnaire along with the COST-Functional Assessment of Chronic Illness Therapy (COST-FACT) survey.OTHER:
Opt Out of QuestionnaireDescription:
As part of this intervention, patients declined to participate in the optional questionnaire. However, their data will still be collected through chart review and will be compared to the data of patients who accepted both the questionnaire and navigation services.
Outcome Measures
Primary Outcome Measures
Number of Patients Who Complete Radiation Therapy
Secondary Outcome Measures
Number of Patients Successfully Impacted by Patient Navigation on Radiation Therapy
Investigate The Differences in Financial Toxicity Levels
Timeline
Last Updated
November 18, 2025Start Date
June 11, 2025Today
December 19, 2025Completion Date ( Estimated )
October 1, 2030
Sponsors of this trial
Lead Sponsor
University of OklahomaCollaborating Sponsors
Gilead Sciences, Radiation Therapy Oncology Group, Susan G. Komen Breast Cancer Foundation
RECRUITING 
18 - 80 Years