Stage IV Lung Cancer AJCC v8 Clinical Trial
Official title:
BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living With Advanced Lung Cancers
Verified date | January 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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. | Baseline to 6 months | |
Secondary | 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 | |
Secondary | Change in patients Palliative Score (POS) | Change in patients Palliative Score (POS) from baseline, 3 months vs. 6 months. | Baseline to 6 months | |
Secondary | 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 | |
Secondary | Perceptions of the BeWell360-Care Giver (CG) model | Caregiver, patients, and clinicians' perceptions of the BeWell360-CG model using questionnaires | Baseline to 6 months |
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