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

NCT07014618 | Recruiting

• 1 other identifier: OU-SCC-NAVAH
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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

Keywords

Native American (NA)

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Complete Radiation Therapy

  Survey-based methods will be used to assess barriers facing under-represented minority cancer patient access to patient navigation. This study will use a patient-completed, culturally sensitive survey adapted from "Walking Forward," a patient navigator program providing culturally appropriate community education on cancer, screening and treatment, to include barriers to specific RT regimens, and concerns regarding transportation.

  6 months

Secondary Outcomes (2)

• Number of Patients Successfully Impacted by Patient Navigation on Radiation Therapy

  6 Months

• Investigate The Differences in Financial Toxicity Levels

  6 Months

Study Arms (1)

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 Surveys; Other: Opt Out of Questionnaire

Interventions

Pre & Post Surveys OTHER

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.

Consented to Study

Opt Out of Questionnaire OTHER

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.

Consented to Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• Gilead Sciences: collaborator
• Radiation Therapy Oncology Group: collaborator
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Interventions

Lead

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Shearwood McClelland III, MD

  OU Health Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Onco Nurse

CONTACT

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

Shearwood McClelland III, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 11, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2030
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)