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

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.

Study Overview

• Status: Completed
• Conditions: Stage III Lung Cancer AJCC v8; Advanced Lung Carcinoma; Stage IV Lung Cancer AJCC v8
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Educational Intervention; Other: Health Promotion and Education

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard of care services; Other Names: standard of care; standard therapy; Other: Educational Intervention; Receive additional educational and supportive material; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard of care services; Other Names: standard of care; standard therapy; Other: Health Promotion and Education; Participate in BeWell360-CG Care Model sessions

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Moain Abu Dabrh, MB, BCh, Mayo Clinic; Principal Investigator: Maisha T. Robinson, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2021
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Quality of Health Care; Quality Indicators, Health Care; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Guidelines as Topic; Quality Assurance, Health Care; Health Education; Methods; Standard of Care; Early Intervention, Educational; Educational Status; Practice Guidelines as Topic; Health Promotion
• Other Study ID Numbers: MC200201 (Other Identifier: Mayo Clinic); NCI-2022-08655 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 20-006003 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No