deltatrials
Completed NA INTERVENTIONAL 2-arm NCT05640765

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

Sponsor: Mayo Clinic

Updated 7 times since 2023 Last updated: Oct 9, 2025 Started: Feb 3, 2021 Primary completion: Apr 11, 2022 Completion: Apr 11, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Advanced Lung Carcinoma and Stage III Lung Cancer AJCC v8 and is currently completed. Mayo Clinic leads this study, which shows 7 recorded versions since 2021 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2023 – ~Jun 2023 · 5 months · monthly snapshotRecruiting~Jun 2023 – ~Feb 2024 · 8 months · monthly snapshotActive Not Recruiting~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshotActive Not Recruiting~Jan 2025 – ~Nov 2025 · 10 months · monthly snapshotActive Not Recruiting~Nov 2025 – present · 5 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Nov 2025 — Present [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

  2. Jan 2025 — Nov 2025 [monthly]

    Active Not Recruiting NA

  3. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  5. Feb 2024 — Jul 2024 [monthly]

    Active Not Recruiting NA

Show 2 earlier versions
  1. Jun 2023 — Feb 2024 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  2. Jan 2023 — Jun 2023 [monthly]

    Recruiting NA

    First recorded

Feb 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mayo Clinic
Data source: Mayo Clinic

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations