Recruiting

Radiation Therapy

Sponsor:

University of Oklahoma

Code:

NCT07014618

Conditions

Breast Cancer

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pre & Post Surveys

Opt Out of Questionnaire

Study Details

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.

Conditions

Breast Cancer

Prostate Cancer

Study ID

NCT07014618

Start date

Oct 16, 2025

Status verified date

Dec, 2025

Completion date

Oct, 2030

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

420 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Pre & Post Surveys

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.

Opt Out of Questionnaire

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.

Primary outcome measure

  • Number of Patients Who Complete Radiation Therapy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Lead Onco Nurse

405-271-8777SCC-IIT-Office@ouhsc.edu

Shearwood McClelland III, MD

405-271-3016Shearwood-McClelland@ouhsc.edu

Locations

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

Shearwood McClelland III, MD

405-271-3016Shearwood-McClelland@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Native American (NA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2025-12-17.