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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
55
Receive standard of care services
Receive additional educational and supportive material
Participate in BeWell360-CG Care Model sessions
Ancillary studies
Mayo Clinic in Florida
Jacksonville, Florida, United States
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 \[(e.g. Zarit Caregiver Burden, Palliative Score scale\].
Time frame: 3-6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months
Change in patients Palliative Score (POS)
Change in patients Palliative Score (POS) from baseline, 3 months vs. 6 months.
Time frame: 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.
Time frame: Baseline to 6 months
Perceptions of the BeWell360-Care Giver (CG) model
Caregiver, patients, and clinicians' perceptions of the BeWell360-CG model using questionnaires
Time frame: Baseline to 6 months
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