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Clinical Trials/NCT05640765
NCT05640765
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country55 target enrollmentFebruary 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Mayo Clinic
Enrollment
55
Locations
1
Primary Endpoint
Change in caregiver burden scores
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2021
End Date
April 11, 2022
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in caregiver burden scores

Time Frame: 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 Outcomes

  • Change in caregivers' stress- and behavior-related scores(Baseline to 6 months)
  • Perceptions of the BeWell360-Care Giver (CG) model(Baseline to 6 months)
  • Change in caregivers functional scores(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)
  • Change in Patient Health Questionnaire Depression (PHQ8)(Baseline to 6 months)

Study Sites (1)

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