Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pre & Post Surveys, Opt Out of Questionnaire.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Prostate Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Navigator-Assisted Hypofractionation (NAVAH) on Radiation Therapy Completion in Breast Cancer and Prostate Cancer
Overview
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.
Interventions
- Other 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) - Other 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 measures
- Number of Patients Who Complete Radiation Therapy [Time frame: 6 months]
Secondary outcome measures (2)
- Number of Patients Successfully Impacted by Patient Navigation on Radiation Therapy [Time frame: 6 Months]
- Investigate The Differences in Financial Toxicity Levels [Time frame: 6 Months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- OU Health Stephenson Cancer Center — Oklahoma City
Identifiers
NCT: NCT07014618 · OU-SCC-NAVAH