Advanced Lung Carcinoma, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
Conditions
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.
Interventions
OTHERBest Practice
Receive standard of care services
OTHEREducational Intervention
Receive additional educational and supportive material
OTHERHealth Promotion and Education
Participate in BeWell360-CG Care Model sessions
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in caregiver burden scores | 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 \[(e.g. Zarit Caregiver Burden, Palliative Score scale\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in caregivers' stress- and behavior-related scores | Baseline to 6 months | Change in caregivers' stress- and behavior-related scores (e.g. Generalized Anxiety Disorder \[GAD7\]) from baseline vs. 6 months. |
| Change in Patient Health Questionnaire Depression (PHQ8) | Baseline to 6 months | Change in caregivers' stress- and behavior-related scores (e.g. Patient Health Questionnaire Depression \[PHQ8\] from baseline vs. 6 months. |
| Change in caregivers functional scores | Baseline to 6 months | Change in caregivers functional scores (e.g. World Health Organization Disability Schedule \[WHODAS\]-12/36) from baseline versus (vs.) 6 months. |
| Change in patients Treatment burden (TBQ) scores | Baseline to 6 months | Change in patients Treatment burden (TBQ) scores from baseline, 3 months vs. 6 months. |
| Perceptions of the BeWell360-Care Giver (CG) model | Baseline to 6 months | Caregiver, patients, and clinicians' perceptions of the BeWell360-CG model using questionnaires |
| Change in patients Palliative Score (POS) | Baseline to 6 months | Change in patients Palliative Score (POS) from baseline, 3 months vs. 6 months. |
Countries
United States
Outcome results
None listed