Effectiveness of Central Oncology Navigation and the Use of an ORN

Официальное название

Navigation and Research: Evaluating the Intervention of Central Navigation and an Oncology Research Navigator (ORN) on Cancer Outcomes and Clinical Trial Enrollment (NAVIGATE Trial)

Обзор

This health services interventional study investigates the effectiveness of central oncology navigation (SOC ) alone and central oncology navigation with a new role called an "oncology research navigator (ORN)" who is embedded in central oncology navigation cancer care delivery. This study will examine two patient cohorts: Cohort 1 will enroll patients with new cancer appointments within genitourinary (GU) or thoracic cancers. These clinics have not yet implemented the central navigation program. Participants will be enrolled pre- and post-implementation of the central oncology navigator within these cancer groups to evaluate the effectiveness of the central oncology navigator alone. The second cohort will enroll participants with new cancer appointments within gastrointestinal (GI), hematology, and breast cancer (clinics where the central navigation program was implemented). These individuals will be randomized to receive standard of care, which for these cancer types includes central oncology navigation or the intervention of an oncology research navigator in addition to SOC. This intervention will involve baseline and biweekly follow-up for a total of 3 months. Interactions with the ORN will include facilitating participation in supportive care services and clinical trials. All participants will undergo baseline and follow-up patient-reported outcomes and data collection. The study will evaluate the impact of the central oncology navigation program alone, as well as the addition of the ORN on patient quality of life, as well as enrollment into studies and participation in supportive care services. Additional analyses will evaluate the impact of the central oncology navigation program on patient experience, patient activation, net promoter scores, and overall survival.

Вмешательства

• Поведенческое Intervention of oncology research navigator embedded in central oncology navigation
  The intervention of oncology research navigator or Oncology research navigator (ORN) is embedded in central oncology navigation cancer care delivery.
• Поведенческое Central oncology navigation (SOC)
  Central oncology navigation (SOC ) alone.

Первичные конечные точки

• Cohort 1-supportive service offered [Срок оценки: Up to 6 months]
• Cohort 2: number of patients enrolled [Срок оценки: Up to 6 months]

Вторичные конечные точки (6)

• Cohort 1: Health-related quality of life [Срок оценки: Baseline and 3 months]
• Cohort 1: Patient activation [Срок оценки: Baseline and 3 months]
• Cohort 1: Patient experience [Срок оценки: Baseline and 3 months]
• Cohort 1: Net promoter [Срок оценки: Baseline and 3 months]
• Cohort 1: Overall Survival [Срок оценки: Up to 5 years]
• Cohort 2: Health-related quality of life [Срок оценки: Baseline and 3 months]

Критерии участия

Критерии включения

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

• Informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Subject is willing and able to comply with study activities based on the judgement of the investigator.
• Age ≥ 18 years at the time of consent.
• Subject has a new patient appointment for cancer care at a UNC Medical Center and a confirmed cancer diagnosis.

Критерии исключения

• Lack of internet access.
• Inability to understand the English language.
• Psychological or other disability resulting in the inability to provide informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UNC Lineberger Comprehensive Cancer Center — Chapel Hill

Идентификаторы

NCT: NCT06618274 · LCCC2334

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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