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Trial Title:
BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living With Advanced Lung Cancers
NCT ID:
NCT05640765
Condition:
Advanced Lung Carcinoma
Stage III Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive standard of care services
Arm group label:
Arm 1: (Standard of care + Educational material)
Arm group label:
Arm 2: (Standard of care + BeWell360-CG)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Receive additional educational and supportive material
Arm group label:
Arm 1: (Standard of care + Educational material)
Other name:
Education for Intervention
Other name:
Intervention by Education
Other name:
Intervention through Education
Other name:
Intervention, Educational
Intervention type:
Other
Intervention name:
Health Promotion and Education
Description:
Participate in BeWell360-CG Care Model sessions
Arm group label:
Arm 2: (Standard of care + BeWell360-CG)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm 1: (Standard of care + Educational material)
Arm group label:
Arm 2: (Standard of care + BeWell360-CG)
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Start date:
January 21, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05640765
https://www.mayo.edu/research/clinical-trials
