BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living With Advanced Lung Cancers

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. ARM 2: 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.

Official Title
-----------------
BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living With Advanced Lung Cancers

Conditions
-----------------
Advanced Lung Carcinoma, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8

Intervention / Treatment
-----------------
* Other: Best Practice
* Other: Educational Intervention
* Other: Health Promotion and Education
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: (Standard of care + Educational material)<br>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. | Other: Best Practice<br>* Receive standard of care services<br>* Other names: standard therapy;Other: Educational Intervention<br>* Receive additional educational and supportive material<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Arm 2: (Standard of care + BeWell360-CG)<br>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. | Other: Best Practice<br>* Receive standard of care services<br>* Other names: standard therapy;Other: Health Promotion and Education<br>* Participate in BeWell360-CG Care Model sessions<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caregiver burden scores | 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]. | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caregivers functional scores | Change in caregivers functional scores (e.g. World Health Organization Disability Schedule [WHODAS]-12/36) from baseline versus (vs.) 6 months. | Baseline to 6 months | 
| Change in caregivers' stress- and behavior-related scores | Change in caregivers' stress- and behavior-related scores (e.g. Generalized Anxiety Disorder [GAD7]) from baseline vs. 6 months. | Baseline to 6 months | 
| Change in Patient Health Questionnaire Depression (PHQ8) | Change in caregivers' stress- and behavior-related scores (e.g. Patient Health Questionnaire Depression [PHQ8] from baseline vs. 6 months. | Baseline to 6 months | 
| Change in patients Palliative Score (POS) | Change in patients Palliative Score (POS) from baseline, 3 months vs. 6 months. | Baseline to 6 months | 
| Change in patients Treatment burden (TBQ) scores | Change in patients Treatment burden (TBQ) scores from baseline, 3 months vs. 6 months. | Baseline to 6 months | 
| Perceptions of the BeWell360-Care Giver (CG) model | Caregiver, patients, and clinicians' perceptions of the BeWell360-CG model using questionnaires | Baseline to 6 months |