BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living With Advanced Lung Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in caregiver burden scores
研究概览
简要总结
This clinical trial aims to develop a new care delivery model, called BeWell360-Care Giver (CG), to support caregivers of patients living with lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). The BeWell360-CG care model may enhance the wellbeing and quality of life of patients living with advanced lung cancer, and improve the current care standards for cancer patients and their caregivers.
详细描述
PRIMARY OBJECTIVES:
I. To pilot a novel, scalable, user-friendly health and wellness coaching (HWC) care model- the BeWell360-CG - that is embedded and integrated as part of a palliative approach to care for CGs of patients with advanced lung cancer.
II. To train palliative care (PC) staff to identify major themes and practical issues (barriers and facilitators) impacting CGs QoL and well-being, within and outside healthcare settings. (Aim 1) III. To evaluate the impact of BeWell360 on the CGs experience of their wellbeing and QoL. (Aim 2) IV. To evaluate the impact of BeWell360 on the quality of care of patients living with advanced lung cancer and receiving PC. (Aim 2) V. To create foundational knowledge about the feasibility and proof of concept of BeWell360-CG within PC for further future implementation and dissemination (translation) into practice. (Aim 3)
OUTLINE: Caregivers (CGs) are assigned to 1 of 2 arms.
ARM 1: CGs receive the standard of care services assigned by the care team for their patient. Participants also receive additional educational and supportive material for health and wellness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CGs of patients with advanced lung cancer receiving care at Mayo Clinic Florida (MCF) in the Palliative Care (PC) or Oncology clinics
- •Patient with a predicted life expectancy >=6 months
- •Adult CGs' of any gender, race and ethnicity
- •English speaking
- •Willing to provide informed consent and complete HWC sessions, study interviews, and surveys. We will identify the respective patients through the patient appointment schedule list and use the patient electronic medical record (EMR) to confirm the point of contact of CGs.
- •Palliative Care staff participating in the research study
排除标准
- •Patients or CGs who are unable to complete surveys, coaching sessions and participate in interviews. Palliative Care clinicians will determine inability to participate based on burden to patient and clinical diagnosis.
研究组 & 干预措施
Arm 2: (Standard of care + BeWell360-CG)
CGs receive the standard of care services assigned by the care team for their patient and participate in the BeWell360-CG coaching sessions on study.
干预措施: Health Promotion and Education (Other)
Arm 2: (Standard of care + BeWell360-CG)
CGs receive the standard of care services assigned by the care team for their patient and participate in the BeWell360-CG coaching sessions on study.
干预措施: Questionnaire Administration (Other)
Arm 1: (Standard of care + Educational material)
CGs receive the standard of care services assigned by the care team for their patient. Participants also receive additional educational and supportive material for health and wellness.
干预措施: Best Practice (Other)
Arm 1: (Standard of care + Educational material)
CGs receive the standard of care services assigned by the care team for their patient. Participants also receive additional educational and supportive material for health and wellness.
干预措施: Educational Intervention (Other)
Arm 1: (Standard of care + Educational material)
CGs receive the standard of care services assigned by the care team for their patient. Participants also receive additional educational and supportive material for health and wellness.
干预措施: Questionnaire Administration (Other)
Arm 2: (Standard of care + BeWell360-CG)
CGs receive the standard of care services assigned by the care team for their patient and participate in the BeWell360-CG coaching sessions on study.
干预措施: Best Practice (Other)
结局指标
主要结局
Change in caregiver burden scores
时间窗: 3-6 months
Change in caregiver burden scores baseline, 3 months vs 6 months (or last follow-up) in caregivers as measured by burden-assessment scores \[(e.g. Zarit Caregiver Burden, Palliative Score scale\].
次要结局
- Change in caregivers' stress- and behavior-related scores(Baseline to 6 months)
- Perceptions of the BeWell360-Care Giver (CG) model(Baseline to 6 months)
- Change in caregivers functional scores(Baseline to 6 months)
- Change in patients Palliative Score (POS)(Baseline to 6 months)
- Change in patients Treatment burden (TBQ) scores(Baseline to 6 months)
- Change in Patient Health Questionnaire Depression (PHQ8)(Baseline to 6 months)