A Randomized, Controlled Prospective Trial Evaluating The Impact Of A Nurse Navigation Program on Patients With Gastrointestinal Cancers Undergoing Oncological Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Annualized Count of Acute Care Visits
研究概览
简要总结
The purpose of this study is to learn about the impact of the Oncology Nurse Navigation program on the frequency of Emergency Department, urgent care visits and inpatient hospital admissions; and overall survival rate at 6 months. The investigators aim to understand if prompt and effective coordination of care provided by Oncology Nurse Navigation (ONN) service will reduce the number of avoidable, unplanned ED visits and hospitalizations, as well as adding measurable value to cancer care, and improve patient overall survival.
详细描述
A randomized controlled prospective trial evaluating the effectiveness of a nurse navigation program for gastrointestinal cancer patients undergoing oncological treatment. Upon accrual, patients will be randomized 1:1 to receive standard of care plus ONN service (n = 107) or standard of care only (without ONN service; n = 107). Patients in both arms will be assessed for acute care utilization and overall survival (OS) rate at 6 months. Anticipated accrual period will be 30 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Informed consent and HIPAA authorization for the release of personal health information
- •Aged ≥ 18 years at the time of consent
- •Subject is planning to receive their cancer care at LCI at the time of consent
- •Treatment naïve OR adjuvant greater than 6 months ago, histologically or cytologically confirmed one of the following diagnoses (metastatic/recurrent status can be radiologically confirmed):
- •Metastatic/recurrent or locally advanced, unresectable or borderline resectable (as defined per NCCN, Alliance or other acceptable guidelines criteria) pancreatic cancer
- •Metastatic/recurrent or locally advanced, unresectable esophageal, gastroesophageal junction (GEJ) or gastric cancer patients or those who are not eligible for surgery
- •Metastatic/recurrent or locally advanced, unresectable hepatocellular carcinoma (HCC)
- •radiographic confirmation of the HCC diagnoses is acceptable
- •prior locoregional treatment for subjects with HCC is allowed, but no prior systemic therapy is allowed
- •Metastatic/recurrent or advanced, unresectable biliary cancers (e.g. gall bladder cancer, cholangiocarcinoma)
- •prior locoregional treatment for subjects with biliary cancers is allowed, but no prior systemic therapy is allowed
- •Metastatic colorectal or small bowel cancer patients who had disease progression on or are intolerant to fluorouracil/capecitabine, oxaliplatin, and irinotecan-based therapy (e.g. FOLFOX, FOLFIRI or FOLFOXIRI)
- •Subjects can be enrolled within, but no later than 30 days after initiation of their systemic therapy, however every effort will be made to enroll subjects prior to the initiation of systemic therapy. Subjects who has completed or undergoing a current palliative radiotherapy are allowed
- •Ability to read and understand the English or Spanish language
- •As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study. However, refusal to complete a patient satisfaction questionnaire IL109 should not refrain a subject from being enrolled.
- •Life expectancy is > 3 months
排除标准
- •Subjects have previously received or are currently receiving LCI Patient Navigation Program services
- •Subjects with colorectal cancer enrolled in the Empower Program
- •Subjects with low grade neuroendocrine tumors
研究组 & 干预措施
Standard of Care
Standard of Care
Oncology Nurse Navigation
Standard of Care + Oncology Nurse Navigation
干预措施: Oncology Nurse Navigation (Other)
结局指标
主要结局
Annualized Count of Acute Care Visits
时间窗: From the date of randomization until subject discontinued the intervention, assessed up to 34 months
The annualized count of acute care visits, where acute care visits included all unplanned inpatient admissions, emergency room encounters, and/or urgent care visits, was calculated for each subject as the total number of acute care visits normalized to an annual basis.
Proportion of Participants Surviving at 6 Months
时间窗: From the date of randomization to death or 6 months
The proportion of participants surviving at 6 months was calculated for each treatment arm. Six-month overall survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 6 months after study enrollment. Failure occurred if the subject died from any cause within 6 months of study enrollment. The proportions were compared between the arms.
次要结局
- Time From Hospice Referral to Death for Participants Referred to Hospice(From the date of hospice referral to death or last follow-up, assessed over 7 months.)
- Proportion of Participants Referred to Supportive Care Services(From the date of randomization until subject discontinued the intervention, assessed up to 34 months)
- Proportion of Participants Surviving at 12 Months(From the date of randomization up until 12 months)
- Hospital Length of Stay(From the date of randomization until subject discontinued the intervention, assessed up to 34 months)
- Total Number of 30-day Readmissions(From the date of randomization until subject discontinued the intervention, assessed up to 34 months)
- Proportions of Missed Visits of All Scheduled Visits From 0% to 100%.(From the date of randomization until subject discontinued the intervention, assessed up to 34 months)
- Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33(From the date of randomization up until 14 weeks)