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

Not Applicable

Active, not recruiting

• Conditions: Advanced Lung Carcinoma; Stage III Lung Cancer AJCC V8; Stage IV Lung Cancer AJCC V8
• Interventions: Other: Best Practice; Other: Educational Intervention; Other: Health Promotion and Education; Other: Questionnaire Administration

• Registration Number: NCT05640765
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-02-03
• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: (Standard of care + Educational material)	Questionnaire Administration	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 1: (Standard of care + Educational material)	Best Practice	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 1: (Standard of care + Educational material)	Educational Intervention	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: (Standard of care + BeWell360-CG)	Questionnaire Administration	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.
Arm 2: (Standard of care + BeWell360-CG)	Best Practice	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.
Arm 2: (Standard of care + BeWell360-CG)	Health Promotion and Education	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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 Palliative Score (POS)	Baseline to 6 months	Change in patients Palliative Score (POS) from baseline, 3 months 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.
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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States