Skip to main content
OpenTrials
Completed

NCT Number: NCT05640765

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Stage III Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Best Practice

Other

Receive standard of care services

Other names: standard of care, standard therapy

Educational Intervention

Other

Receive additional educational and supportive material

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Health Promotion and Education

Other

Participate in BeWell360-CG Care Model sessions

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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].

Secondary outcomes

  1. Change in caregivers functional scores

    Time frame: Baseline to 6 months

    Change in caregivers functional scores (e.g. World Health Organization Disability Schedule [WHODAS]-12/36) from baseline versus (vs.) 6 months.

  2. Change in caregivers' stress- and behavior-related scores

    Time frame: Baseline to 6 months

    Change in caregivers' stress- and behavior-related scores (e.g. Generalized Anxiety Disorder [GAD7]) from baseline vs. 6 months.

  3. Change in Patient Health Questionnaire Depression (PHQ8)

    Time frame: Baseline to 6 months

    Change in caregivers' stress- and behavior-related scores (e.g. Patient Health Questionnaire Depression [PHQ8] from baseline vs. 6 months.

  4. Change in patients Palliative Score (POS)

    Time frame: Baseline to 6 months

    Change in patients Palliative Score (POS) from baseline, 3 months vs. 6 months.

  5. Change in patients Treatment burden (TBQ) scores

    Time frame: Baseline to 6 months

    Change in patients Treatment burden (TBQ) scores from baseline, 3 months vs. 6 months.

  6. Perceptions of the BeWell360-Care Giver (CG) model

    Time frame: Baseline to 6 months

    Caregiver, patients, and clinicians' perceptions of the BeWell360-CG model using questionnaires

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.