跳至主要内容
临床试验/NCT06618274
NCT06618274招募中不适用

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

UNC Lineberger Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 686 人开始时间: 2025年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
686
试验地点
1
主要终点
Cohort 1-supportive service offered

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Cohort 1

Experimental

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.

干预措施: Central oncology navigation (SOC) (Behavioral)

Cohort 2

Experimental

Cohort 2 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 oncology research navigator in addition to SOC.

干预措施: Intervention of oncology research navigator embedded in central oncology navigation (Behavioral)

结局指标

主要结局

Cohort 1-supportive service offered

时间窗: Up to 6 months

Participation in at least 1 supportive service offered will be measured by the number of patients receiving services. This information will be gathered from chart review.

Cohort 2: number of patients enrolled

时间窗: Up to 6 months

Enrollment into non-treatment clinical studies will be measured by the number of patients enrolled at any time. This information will be gathered from chart review.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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