Health and Wellness Coaching for Lung Cancer Caregivers

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Inability to complete surveys, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new care model called BeWell360-CG, designed to support caregivers of patients with advanced lung cancer. It aims to improve the wellbeing and quality of life for both caregivers and patients through health and wellness coaching sessions. Participants are divided into two groups: one receives standard care plus BeWell360-CG coaching, while the other receives standard care plus educational materials. The trial seeks caregivers of patients with advanced lung cancer who are receiving care at Mayo Clinic Florida and are comfortable participating in coaching sessions and interviews. As an unphased trial, it offers caregivers a unique opportunity to enhance their support skills and improve their own wellbeing.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on caregivers rather than patients, so it's unlikely that medication changes are required.

What prior data suggests that the BeWell360-CG care model is safe for caregivers?

Research has shown that health and wellness coaching, such as the BeWell360-CG program, is generally safe for participants. The BeWell360-CG aims to improve the well-being and quality of life for caregivers of patients with advanced lung cancer.

No specific reports have indicated negative effects from the BeWell360-CG program itself. As a wellness and coaching program, it does not involve medications or medical procedures, making it easy for participants to handle. Participants typically engage in non-invasive coaching sessions that provide support and guidance.

Although detailed safety data from studies on BeWell360-CG is not available, wellness programs like this one are generally considered safe, as they focus on enhancing mental and emotional support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health and Wellness Coaching for Lung Cancer Caregivers trial because it introduces the BeWell360-CG coaching model, which offers personalized support for caregivers beyond the standard educational material. Unlike traditional approaches that primarily focus on the patient's medical needs, BeWell360-CG provides structured coaching sessions tailored to improve the well-being of caregivers themselves. This approach is unique because it emphasizes the mental and emotional health of caregivers, aiming to reduce their stress and improve their quality of life, which can indirectly benefit the patient as well.

What evidence suggests that the BeWell360-CG care model is effective for supporting caregivers of patients with advanced lung cancer?

This trial will compare the BeWell360-CG care model with standard care plus educational material for caregivers of patients with advanced lung cancer. Research has shown that the BeWell360-CG care model might improve the wellbeing and quality of life for these caregivers. Studies suggest that health and wellness coaching can help reduce stress and improve mental health for caregivers. Early findings indicate that caregivers using BeWell360-CG feel less overwhelmed and receive more support. While researchers continue to gather detailed evidence on its effectiveness, the model aims to enhance the experience for both caregivers and patients. Initial signs are promising, showing potential benefits for caregivers' mental and emotional health. ^{2 3 4 5 6}

Who Is on the Research Team?

Moain Abu Dabrh, MB, BCh

Principal Investigator

Mayo Clinic

Maisha T. Robinson, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for caregivers of patients with advanced lung cancer at Mayo Clinic Florida. Caregivers must speak English, expect to live more than 6 months, and be willing to consent to health coaching sessions, interviews, and surveys. It's not for those who can't complete the study activities due to burden or clinical reasons.

Inclusion Criteria

People who work in palliative care cannot take part in the study.

You are expected to live for at least 6 more months.

English speaking

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Caregivers receive either standard care with educational materials or participate in BeWell360-CG coaching sessions

6 months

Regular sessions as per study protocol

Follow-up

Participants are monitored for changes in caregiver burden, functional scores, and stress-related scores

3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• BeWell360-CG Care Model

Trial Overview The BeWell360-CG care model is being tested for its effectiveness in supporting caregivers' wellbeing. This includes educational interventions, questionnaires, best practices in care delivery, and health promotion tailored specifically for caregivers of advanced lung cancer patients.

How Is the Trial Designed?

Group I: Arm 2: (Standard of care + BeWell360-CG) Experimental Treatment 3 Interventions

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.

Group II: Arm 1: (Standard of care + Educational material) Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Preliminary evidence indicates that online supportive care interventions for individuals living with and beyond lung cancer are feasible and acceptable, although most studies are small pilot projects with limited high-level evidence.

Integrating online supportive care into cancer treatment pathways may enhance quality of life and emotional functioning while reducing symptom distress, highlighting the need for further research to expand these supportive care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and efficacy of online supportive care for individuals living with and beyond lung cancer: a systematic review. Curry, J., Patterson, M., Greenley, S., et al.[2022]

This case report highlights the successful use of health and wellness coaching (HWC) for a 44-year-old woman caring for a cancer patient, showing potential benefits in managing her physical health issues like hypertension and high cholesterol over a 1-year period.

The intervention, consisting of 10 sessions, addressed various health components and demonstrated that HWC can lead to positive physical and psychosocial outcomes for cancer caregivers, suggesting it as a valuable support option for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Health and Wellness Coaching With an Adult Cancer Caregiver. Smith, K., Hays, L., Yen, L., et al.[2022]

A study of 96 caregivers of cancer patients in Brazil found that certain sociodemographic factors, such as being separated, a mother, or the sole caregiver, are linked to lower wellness levels.

Caregivers with higher education, lower family income, and existing health problems also reported reduced wellness, highlighting the need for targeted support strategies from healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between wellness and sociodemographic characteristics of caregivers of people with cancer. Tiago de Oliveira, W., Misue Matsuda, L., Aparecida Sales, M.[2018]

Citations

1. withpower.com withpower.com/trial/phase-advanced-lung-carcinoma-2021-125c2

Health and Wellness Coaching for Lung Cancer Caregivers 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 ...

2. clinicaltrial.be clinicaltrial.be/en/details/173928?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

BeWell360-CG Care Model: Health and Wellness ... BeWell360-CG Care Model: Health and Wellness Coaching to Support Caregivers of Patients Living with Advanced Lung Cancers. NCT05640765. NCT.

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05640765?keyword=%22Stage%20IV%20Lung%20Cancer%22

San Mateo Clinical Trial BeWell360-CG Care Model 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 ...

4. mayo.edu mayo.edu/research/clinical-trials/tests-procedures/health-and-wellness-coaching

Health And Wellness Coaching Clinical Trials The purpose of this study is to evaluate the impact of the BeWell360 coaching care model to improve functional and experience-related outcomes of informal ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT05640765

BeWell360-CG Care Model Outcome Measure, Measure Description, Time Frame. Change in caregiver burden scores, Change in caregiver burden scores baseline, 3 months vs 6 months (or ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20493094

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