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临床试验/NCT07406087
NCT07406087招募中不适用

Adaptation and Implementation of an Evidence-Based Patient Navigation Intervention for Adolescent and Young Adult Cancer Survivors

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年3月15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
25
试验地点
1
主要终点
Perceived Health Competence Scale

研究概览

简要总结

The investigators propose to: 1) Adapt an evidence-based cancer-focused patient navigation (PN) program for the Adolescent and Young Adult (AYA) cancer survivor population; and 2) Plan and conduct an effectiveness-implementation trial of this program within Kaiser Permanente Southern California (KPSC). PLEASE NOTE: This study is awarded in two phases. The UG3 phase has been awarded for the first two years; upon successful completion of this phase by meeting pre-defined milestones, the National Cancer Institute (NCI) will provide funding for the second phase of the study (Years 3-6), which will allow our team to conduct a trial to determine the effectiveness of the implementation of the adapted PN program for the AYA cancer survivor population. This application is focused on the initial UG3 phase and will update the protocol for the UH3 trial upon successful completion of the UG3 milestones and receipt of the UH3 award.

The primary objectives in the UG3 phase of the study are to adapt and tailor an existing PN program to meet the needs of AYA cancer survivors and the local clinical context via (a) interviews with key stakeholders (patients, clinicians, administrators) and (b) guidance from our AYA Primary Care Survivorship Council. The investigators will conduct a pilot study of the adapted PN program and refine the program to enhance acceptability to patients and clinicians, enhance feasibility and effectiveness, and develop and pilot evaluation tools and methods prior to the start of the UH3 phase of the trial, which will be a larger trial. Objectives will be updated for the UH3 phase once awarded.

详细描述

In the UG3 phase, the investigators will be adapting a patient navigation (PN) intervention to suit adolescent and young adult (AYA) cancer survivors and conducting a single-site pilot test of the adapted intervention. In the UH3 phase, the investigators will conduct a pragmatic stepped wedge hybrid effectiveness implementation trial evaluating (1) clinical effectiveness and (2) implementation outcomes, across a range of data sources.

Intervention:

Navigator-level: For the pilot test in the UG3 phase, the investigators will provide PN training for the adapted AYA PN program to at least one navigator. The investigators anticipate that navigators will undergo a comprehensive training curriculum that draws on existing Kaiser Permanente Southern California (KPSC) PN program trainings and includes primary care and cancer survivorship/surveillance components and established recommendations for cancer survivorship navigation from the American Society of Clinical Oncology (ASCO) and others. These resources include core navigation competencies for survivorship, patient assessment, scope of practice, etc. These trainings will be completed with additional focus areas/domains identified during the adaptation processes. Based on the structure of the existing PN program, it is anticipated that monthly review meetings will be held.

Patient-level: For the pilot test in the UG3 phase, the investigators will identify eligible patients from a single clinical site within KPSC. The investigators anticipate enrolling 15-25 patients in the pilot. Patients will receive a letter and brochure describing the adapted AYA PN program with a bio of their assigned navigator and how the program will help integrate primary care and cancer survivorship needs. It is strongly anticipated that navigation 'touches' will include progressive steps via a combination of delivery modes as with the existing PN programs: 1) email: patients with KP.org patient portal accounts will receive email communication from navigators; 2) text: patients with registered mobile phone in KP membership files will receive text-based communications; 3) calls: patients will receive calls from their navigator to discuss scheduling, overdue recommended care, and motivational coaching; 4) letters: patients may receive letters if unable to be reached via email, text, and calls. Navigators will work with the electronic medical record (EMR) to identify need for recommended healthcare services and gaps in care, working with the care team to pend orders for physician review and work directly with the patient using motivational interviewing skills to encourage participation in care, address social needs, and identify care goals. PN program milestones, developed based on established recommendations for survivorship navigation metrics and the input from our adaptation processes, will likely include patients contacted, engagement activities, and pending orders for physician review for overdue services.

System-level: As part of the UG3 phase, the investigators will work closely with our partners to adapt the PN program to suit existing clinical needs and workflows. 2-3 focus groups will be held with care teams (nurses/physicians/advanced practice providers) and department administrators (DAs) using a semi-structured focus group format. These groups will provide feedback on the team-based care focus for the PN program, how to integrate seamlessly into existing clinical workflows, suggestions for use and/or expansion of existing KPSC information technology (IT) tools (e.g., the Complete Care Model tools), and clinical needs of the patient population. Using adapted health IT tools, flags may be created for patients due for recommended services.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Received diagnosis of local or regional breast, ovarian, cervical, testicular, colon/rectal, melanoma, endometrial, sarcoma, or thyroid cancer between the ages of 15-39 years ("index cancer")
  • Current age 21-45 years
  • Diagnosed and treated for index cancer within Kaiser Permanente Southern California adult medical oncology and/or surgery
  • Current Kaiser Permanente insurance coverage

排除标准

  • Patients with a history of or current diagnosis of leukemia or lymphoma
  • Patients with metastatic disease at diagnosis

研究组 & 干预措施

Adapted Patient Navigation Program

Experimental

The primary objectives in the UG3 phase of the study are to adapt and tailor an existing patient navigation program to meet the needs of AYA cancer survivors and the local clinical context. Adolescent and young adult cancer survivors will be enrolled in a single arm pilot study of the adapted navigation program.

干预措施: Adapted patient navigation program targeting adolescent and young adult cancer survivors (Behavioral)

结局指标

主要结局

Perceived Health Competence Scale

时间窗: From enrollment to completion at 6 months post-enrollment

Patient survey outcome; 8 items measured on a Likert scale (1-5) with higher scores associated with higher health competence

次要结局

  • Weiner's Appropriateness, Acceptability, and Feasibility(From enrollment to completion at 6 months post-enrollment)
  • Weiner's Appropriateness, Acceptability, and Feasibility(Baseline to 6 months post-patient enrollment into navigation program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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