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

75 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment BeWell360-CG Care Model for lung cancer caregivers?

Research on health and wellness coaching (HWC) with cancer caregivers, like the case of a caregiver for a patient with neuroendocrine tumors, shows that HWC can help improve physical health, reduce stress, and enhance overall well-being. This suggests that similar coaching models, like BeWell360-CG, may also be beneficial for lung cancer caregivers. ^{1 2 3 4 5}

Is health and wellness coaching safe for caregivers of cancer patients?

The case report on health and wellness coaching for a caregiver of a cancer patient showed no safety concerns, suggesting it may be a safe option for promoting health in caregivers. ^{1 2 4 6 7}

How does health and wellness coaching differ from other treatments for lung cancer caregivers?

Health and wellness coaching is unique because it focuses on supporting caregivers' overall well-being, including physical health, stress management, and relationship success, rather than directly treating a medical condition. This approach is designed to help caregivers make sustainable lifestyle changes, which can improve their quality of life and ability to care for their loved ones. ^{1 2 4 6 8}

What is the purpose of this trial?

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.

Research Team

Moain Abu Dabrh, MB, BCh

Principal Investigator

Mayo Clinic

Maisha T. Robinson, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physical health, mental health, and life changes among family caregivers of patients with lung cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Health and Wellness Coaching With an Adult Cancer Caregiver. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

The unmet supportive care needs-what advanced lung cancer patients' caregivers need and related factors. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Lung Cancer Patient and Caregiver Health Vulnerabilities and Interest in Health Promotion Interventions: An Exploratory Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Wellness Education on Quality of Life of Patients With Non-Small Cell Lung Cancer Treated With First-Line Icotinib and on Their Family Caregivers. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Quality of life of family caregivers and challenges faced in caring for patients with lung cancer. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and efficacy of online supportive care for individuals living with and beyond lung cancer: a systematic review. [2022]

8. Colombia pubmed.ncbi.nlm.nih.gov

Relationship between wellness and sociodemographic characteristics of caregivers of people with cancer. [2018]