Improving Survivorship Care Through Enhanced Communication and Coordination: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Number of participants with increased patient confidence about Survivorship Care
研究概览
简要总结
Purpose: Cancer survivorship is a high clinical and research priority both nationally and at the University of North Carolina. The investigators propose a randomized pilot study testing the development, implementation and evaluation of a parallel patient and streamlined provider version of a personalized Survivorship Care Plan (SCP) with lung cancer patients.
Participants: 60 lung cancer patients at Rex Cancer Center.
Procedures (methods): Participants will be recruited and randomized to the standard of care (30 patients) or intervention (30 patients) arm. Patients randomized to standard of care will receive a tailored survivorship care plan at the end of cancer treatment. Patients randomized to the intervention will receive a care plan and coordinating visit with their primary care provider. Patients will be invited to complete baseline and follow-up assessments regarding care needs and confidence in post cancer care.
All patient primary care providers will receive condensed provider versions of the care plan. Providers will be asked to evaluate how the SCP and coordinated care visit (intervention only) facilitated communication and coordination of care.
详细描述
Eligible participants ending or recently ending treatment will be identified weekly by the Rex Care Coordinator. The Rex Care Coordinator will contact eligible patients before cancer treatment ends to schedule an exit interview and to describe the study, get permission to share contact information with the program manager (PM), and provide the written consent form to the patient.
Two weeks prior to the scheduled exit interview, the PM will contact the patient to provide additional details about the study and obtain consent from the patient. The PM will mail baseline data collection measures to the patient to complete and bring to exit interview visit.
The PM will contact the PCP of consented patients via email or letter informing them of their patient's participation in the study and inviting them to participate as well. Providers will receive a fact sheet about the study and a confidential email link to Qualtrics to complete surveys regarding patient survivorship care. Their participation in the survey will convey consent. The link will confirm provider name and that patient is seen by the provider. A separate link will allow the provider to enter responses and maintain separation of patient identifiers and responses.
It is possible that PCPs may see multiple patients in our study, but this will not be the majority of PCPs. Providers will be asked to complete a survey for each patient. It is also possible providers may treat patients who are randomized to both arms. Because of the small sample size and the focus on feasibility, we will not limit PCPs to only see survivors in one group. The rate of this occurrence and preliminary data obtained from this pilot study will inform design/sample size calculations for the Phase III trial.
At least one week prior to the scheduled exit interview, the Rex Research Nurse will be informed by the PM to develop the SCP using the JourneyForward™ template. The Rex Research Nurse will keep a log of how long it takes to complete the SCP and any issues that arise preparing them. Tailored SCPs will be developed for each eligible patient using the template based on information on the patient's medical and cancer records.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>21 years
- •Able to read and speak English will be eligible to participate
- •Diagnosed with a smoking-related cancer (initial accrual priority is lung cancer, followed by head and neck, esophageal and cervical cancer)
- •Treated at Rex Cancer Center for cancer
- •Completed treatment within the past three months-
- •Have a designated primary care provider (PCP)
排除标准
- •patient does not meet inclusion criteria
- •patient diagnosed with metastatic cancer
结局指标
主要结局
Number of participants with increased patient confidence about Survivorship Care
时间窗: Up to six weeks
To compare the change in confidence about survivorship care between patients who receive a coordinated care visit with their PCP (intervention group) compared to those who do not have this visit (control group). The project will use 8 questionnaires to assess changes in patient and provider confidence and patient concerns over the course of the study. The primary objective in this one year study is to compare changes in Confidence in Survivorship Information Questionnaire (CSI) scores among patients receiving the proposed standard of care survivorship care plan (30 patients) to patients receiving care plans and a coordinated PCP visit (30 patients) to determine whether the delivery of tailored SCPs increases the confidence of survivors in receiving post treatment cancer care.
次要结局
- Number of providers with increased confidence about survivorship(Up to 6 weeks)
- Patient Activation Score(Up to 6 weeks)