Clinical trial NCT05640765: BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living with Advanced Lung Cancers
Official title: BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living with Advanced Lung Cancers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Advanced Lung Carcinoma
Stage III Lung Cancer AJCC V8
Stage IV Lung Cancer AJCC V8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in caregiver burden scores
timeFrame: 3-6 months
Secondary outcomes:
measure: Change in caregivers functional scores
timeFrame: Baseline to 6 months
measure: Change in caregivers' stress- and behavior-related scores
timeFrame: Baseline to 6 months
measure: Change in Patient Health Questionnaire Depression (PHQ8)
timeFrame: Baseline to 6 months
measure: Change in patients Palliative Score (POS)
timeFrame: Baseline to 6 months
measure: Change in patients Treatment burden (TBQ) scores
timeFrame: Baseline to 6 months
measure: Perceptions of the BeWell360-Care Giver (CG) model
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Moain Abu Dabrh, MB, BCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Maisha T. Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References: