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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-08655 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC200201 | Other Identifier | Mayo Clinic | |
| 20-006003 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care services |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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]. | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months |
| Change in caregivers' stress- and behavior-related scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moain Abu Dabrh, MB, BCh | Mayo Clinic | Principal Investigator |
| Maisha T. Robinson, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Educational Intervention | Other | Receive additional educational and supportive material |
|
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| Health Promotion and Education | Other | Participate in BeWell360-CG Care Model sessions |
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| Questionnaire Administration | Other | Ancillary studies |
|
Change in caregivers' stress- and behavior-related scores (e.g. Generalized Anxiety Disorder [GAD7]) from baseline vs. 6 months. |
| 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. | Baseline to 6 months |
| Change in patients Palliative Score (POS) | Change in patients Palliative Score (POS) from baseline, 3 months vs. 6 months. | 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. | Baseline to 6 months |
| Perceptions of the BeWell360-Care Giver (CG) model | Caregiver, patients, and clinicians' perceptions of the BeWell360-CG model using questionnaires | Baseline to 6 months |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D006293 | Health Promotion |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D006266 | Health Education |
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