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.
Trial 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). Read more about this study
- 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
- Are there results?
- None posted in the registry
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moain Abu Dabrh, MB, BCh, Principal investigator, Mayo ClinicMaisha T. Robinson, MD, Principal investigator, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living With Advanced Lung Cancers
- ClinicalTrials.gov ID
- NCT05640765
- Acronym / sponsor ID
- MC200201
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: (Standard of care + Educational material) | Active comparator | Other: Best Practice, Other: Educational Intervention, Other: Questionnaire AdministrationCGs 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) | Experimental | Other: Best Practice, Other: Health Promotion and Education, Other: Questionnaire AdministrationCGs receive the standard of care services assigned by the care team for their patient and participate in the BeWell360-CG coaching sessions on study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care services | Other | Arm 1: (Standard of care + Educational material), Arm 2: (Standard of care + BeWell360-CG) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive additional educational and supportive material | Other | Arm 1: (Standard of care + Educational material) |
| Health Promotion and EducationParticipate in BeWell360-CG Care Model sessions | Other | Arm 2: (Standard of care + BeWell360-CG) |
| Questionnaire AdministrationAncillary studies | Other | Arm 1: (Standard of care + Educational material), Arm 2: (Standard of care + BeWell360-CG) |
Primary outcome
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].
6 secondary outcomes
Change in caregivers functional scores
Time frame: Baseline to 6 months
Change in caregivers' stress- and behavior-related scores
Time frame: Baseline to 6 months
Change in Patient Health Questionnaire Depression (PHQ8)
Time frame: Baseline to 6 months
Change in patients Palliative Score (POS)
Time frame: Baseline to 6 months
Change in patients Treatment burden (TBQ) scores
Time frame: Baseline to 6 months
Perceptions of the BeWell360-Care Giver (CG) model
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moain Abu Dabrh, MB, BCh principal investigator
Mayo Clinic
Maisha T. Robinson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in caregiver burden scores (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.