Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer
NCT ID: NCT07014618
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
420 participants
OBSERVATIONAL
2025-10-16
2030-10-31
Brief Summary
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Detailed Description
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Those who choose to complete the surveys will be offered navigation assistance as part of the study intervention.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 WITHOUT histologically/cytologically confirmed Breast or Prostate Cancer.
* Subjects younger than 18 years old.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Radiation Therapy Oncology Group
NETWORK
Susan G. Komen Breast Cancer Foundation
OTHER
University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Shearwood McClelland III, MD
Role: PRINCIPAL_INVESTIGATOR
OU Health Stephenson Cancer Center
Locations
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OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OU-SCC-NAVAH
Identifier Type: -
Identifier Source: org_study_id