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临床试验/NCT03644173
NCT03644173已完成不适用

Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients

Hackensack Meridian Health4 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2018年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
4
主要终点
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience

研究概览

简要总结

The Personal Resilience Empowerment Program (PREP) at Hackensack Meridian Integrative Health & Medicine was designed in Legacy Meridian to assist all selected patients with upcoming hospitalization. For the "Personal Resilience Empowerment Program (PREP) in the perioperative setting of surgically treated cancer patients", hereafter "the Project or PREP", the Hackensack Meridian Integrative Health & Medicine is designing a new pilot program to focus on the needs of oncology patients.

All patients diagnosed with cancer that will undergo a scheduled surgical (Hepato-Biliary, and Thoracic) procedure in Hackensack Meridian Health and specifically in the Jersey Shore University Medical Center, will be eligible to participate (for more details please see eligibility criteria, section 4).

Overall, this pilot project will include 5 coaching sessions and an introductory session/visit that will take place on the physician's office. The initial physician visit will focus on patient eligibility, introduction to the Project, informed consent and a pre-intervention survey and will be conducted by the principal investigator or one of the sub-investigators listed above. The following 5 sessions will be conducted by one of the integrative health coaches/registered nurses (for details please see section 5). A post-intervention survey will be completed during the final session and repeated at one month, and at 3 months from the final session.

The goal of this project is to investigate whether using the PREP as an intervention in patients diagnosed with cancer would result in improving various metrics including improvements to resilience, sleep, activity, purpose, nutrition, empowerment to manage one's own health and well-being, decrease in pain medication use and more rapid return to previous functional status according to Eastern Cooperative Oncology Group (ECOG).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Patients diagnosed with cancer of the thoracic (lung), hepatobiliary system (cholangiocarcinoma, pancreatic, liver) that will undergo a scheduled surgical procedure
  • Able to understand and sign the informed consent form
  • Willingness to participate in the study and comply with protocol requirements

排除标准

  • Unable to provide consent
  • Unable to participate at the discretion of the PI based on the ECOG survey (if ECOG >1). See section 5 and appendix 1 for details.
  • Non- English speaking patients .
  • Opioid use for non-malignant pain for greater than 7 days 6 Terminal or Stage 4 cancer.

结局指标

主要结局

Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience

时间窗: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey

Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep

时间窗: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre-intervention survey and 3-month post intervention survey

Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose

时间窗: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey

Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition

时间窗: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey

Change in Quality of Life Post Intervention (Coaching Sessions) - Activity

时间窗: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey

Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment

时间窗: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project. Change between the pre and the 3-month post intervention survey

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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