Advanced Lung CarcinomaNCT05640765

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

A study testing Best Practice, Educational Intervention and Health Promotion and Education in people with Advanced Lung Carcinoma and Stage III Lung Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Advanced Lung Carcinoma, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
What is being tested?: Best Practice, Educational Intervention and Health Promotion and Education
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 3 Feb 2021to 11 Apr 2022
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES:

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.

Conditions: Advanced Lung Carcinoma, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
Being tested: Best Practice, Educational Intervention, Health Promotion and Education, Questionnaire Administration
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care services
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive additional educational and supportive material
Health Promotion and EducationOther
Participate in BeWell360-CG Care Model sessions
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT05640765
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Best Practice; Other: Health Promotion and Education; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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].
Measured: 3-6 months

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 months
Change in patients Palliative Score (POS)
Change in patients Palliative Score (POS) from baseline, 3 months vs. 6 months.
Measured: 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.
Measured: Baseline to 6 months
Perceptions of the BeWell360-Care Giver (CG) model
Caregiver, patients, and clinicians' perceptions of the BeWell360-CG model using questionnaires
Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 202111 Apr 2022

First posted7 Dec 2022
Study start3 Feb 2021
Primary completion11 Apr 2022
Study completion11 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Lung CarcinomaStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05640765
Sponsor's protocol ID: MC200201
Other IDs: NCI-2022-08655, MC200201, 20-006003
Status last verified: Oct 2025
First submitted: 17 Nov 2022
Last updated: 14 Oct 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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