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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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)
• Другое 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.

Первичные конечные точки

• Number of Patients Who Complete Radiation Therapy [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Number of Patients Successfully Impacted by Patient Navigation on Radiation Therapy [Срок оценки: 6 Months]
• Investigate The Differences in Financial Toxicity Levels [Срок оценки: 6 Months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• OU Health Stephenson Cancer Center — Oklahoma City

Идентификаторы

NCT: NCT07014618 · OU-SCC-NAVAH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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