ClinicalTrials.Veeva

Menu

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

Mayo Clinic logo

Mayo Clinic

Status

Completed

Conditions

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

Treatments

Other: Questionnaire Administration
Other: Health Promotion and Education
Other: Educational Intervention
Other: Best Practice

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05640765
MC200201 (Other Identifier)
20-006003 (Other Identifier)
NCI-2022-08655 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

55 participants in 2 patient groups

Arm 1: (Standard of care + Educational material)
Active Comparator group
Description:
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.
Treatment:
Other: Best Practice
Other: Educational Intervention
Other: Questionnaire Administration
Arm 2: (Standard of care + BeWell360-CG)
Experimental group
Description:
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.
Treatment:
Other: Best Practice
Other: Health Promotion and Education
Other: Questionnaire Administration

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems