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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05640765
• Other study ID #: MC200201
• Secondary ID: NCI-2022-08655MC
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Best Practice
Receive standard of care services
• Educational Intervention
Receive additional educational and supportive material
• Health Promotion and Education
Participate in BeWell360-CG Care Model sessions
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials