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

NCT05640765 | Completed DMC

• 3 other identifiers: MC200201NCI-2022-0865520-006003
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Lung Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in caregivers functional scores

  Baseline to 6 months

• Change in caregivers' stress- and behavior-related scores

  Baseline to 6 months

• Change in Patient Health Questionnaire Depression (PHQ8)

  Baseline to 6 months

• Change in patients Palliative Score (POS)

  Baseline to 6 months

• Change in patients Treatment burden (TBQ) scores

  Baseline to 6 months

Study Arms (2)

Arm 1: (Standard of care + Educational material)

ACTIVE COMPARATOR

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; Other: Educational Intervention; Other: Questionnaire Administration

Arm 2: (Standard of care + BeWell360-CG)

EXPERIMENTAL

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; Other: Health Promotion and Education; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care services

Also known as: standard of care, standard therapy

Arm 1: (Standard of care + Educational material); Arm 2: (Standard of care + BeWell360-CG)

Educational Intervention OTHER

Receive additional educational and supportive material

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm 1: (Standard of care + Educational material)

Health Promotion and Education OTHER

Participate in BeWell360-CG Care Model sessions

Arm 2: (Standard of care + BeWell360-CG)

Questionnaire Administration OTHER

Ancillary studies

Arm 1: (Standard of care + Educational material); Arm 2: (Standard of care + BeWell360-CG)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Health Promotion

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Health Education

Study Officials

• Moain Abu Dabrh, MB, BCh

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Maisha T. Robinson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 7, 2022
• Study Start: February 3, 2021
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)