Remote Health Coaching for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Cognitive, psychiatric conditions

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether remote health coaching can reduce fatigue in people with lung cancer. Fatigue, a common and challenging symptom, affects daily life and mood. Participants will use wearable devices and receive weekly phone calls from health coaches to support lifestyle changes over 12 weeks. This trial may suit those with non-small cell lung cancer experiencing moderate to severe fatigue who are receiving care at Mayo Clinic. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance quality of life for many.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this remote monitoring program with health coaching is safe for patients with lung cancer related fatigue?

Studies have shown that combining remote health coaching with exercise is generally safe for people with lung cancer. For instance, one study on a 12-week online exercise program for patients with advanced lung cancer found that participants attended regularly and followed the program well, with no major safety issues. Another study examined remote coaching after an exercise program and found it to be safe and manageable for participants.

These studies suggest that remote health coaching safely helps manage fatigue in lung cancer patients. Participants adhered to the programs without major problems, indicating that the treatment is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Remote monitoring with health coaching is unique because it combines technology and personalized support to help lung cancer patients manage their health from home. Unlike typical treatments that focus primarily on medical interventions like chemotherapy or radiation, this approach emphasizes patient empowerment through routine exercise, daily health tracking, and regular coaching calls. Researchers are excited about this method because it aims to improve patients' quality of life, increase physical activity levels, and potentially lead to better overall outcomes by integrating modern tech with personalized care strategies.

What evidence suggests that remote monitoring with health coaching is effective for lung cancer related fatigue?

Research shows that remote monitoring with health coaching, which participants in this trial will receive, can improve the quality of life for patients experiencing fatigue from lung cancer. Studies have found that these programs increase physical activity and enhance overall well-being. For example, one study found that remote coaching helped participants become more active and feel better emotionally. Another study suggested that these programs might help people stick to exercise routines even after finishing supervised rehabilitation. These findings suggest that remote health coaching positively impacts fatigue and daily life for lung cancer patients. ^{1 2 4 6 7}

Who Is on the Research Team?

Roberto P. Benzo, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced non-small cell lung cancer (NSCLC) who are undergoing treatment and experience moderate to severe fatigue. They must be able to communicate in English or Spanish, have a life expectancy of at least 6 months, and receive care at Mayo Clinic locations specified. Those with cognitive or psychiatric conditions that affect consent or participation cannot join.

Inclusion Criteria

My average fatigue over the last week is 4 or higher.

I can perform daily activities with little to no assistance.

I can read and answer questions in English or Spanish.

Exclusion Criteria

They have cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo routine exercise using a remote monitoring system and receive health coaching for 12 weeks

12 weeks

Weekly health coaching calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Counseling
• Exercise Intervention
• Internet-Based Intervention
• Interview
• Medical Device Usage and Evaluation
• Questionnaire Administration
• Remote Monitoring with Health-Coaching

Trial Overview The study tests a remote monitoring program combined with health coaching aimed at lifestyle changes to alleviate fatigue related to lung cancer. Patients will use medical devices, answer questionnaires, receive exercise counseling and intervention, participate in internet-based interventions, and undergo interviews.

How Is the Trial Designed?

Group I: Supportive care (remote monitoring with health coaching) Experimental Treatment 6 Interventions

Patients undergo routine exercise using a remote monitoring system (Garmin Vívofit activity monitor, Nonin 3150 WristOx2 pulse oximeter, and an Android tablet) over 30 minutes at least 6 days per week and complete daily questionnaires over 20 minutes for 12 weeks. Patients also receive health coaching telephone calls over 5-20 minutes once a week for 12 weeks. At the end of the 12 weeks, patients complete an audio taped telephone interview.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612835/

Home-Based Exercise and Self-Management After Lung ... The findings suggest that although a home-based exercise and self-management program did not improve physical function, it improves some important clinical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04751305

Remote Exercise Maintenance With Health Coaching for ... The secondary aim is to test the effectiveness of the program on physical activity (PA) levels, psychosocial well-being, and physical functioning.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10809633/

Effects of remote coaching following supervised exercise ... This study aimed to assess the effectiveness of a six-month remote coaching intervention, following a supervised exercise oncology rehabilitation program.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1556086424016253

P4.15B.01 Remote Exercise Program for Patients with ... Statistical analyses were performed using linear mixed models to evaluate the effectiveness of the remote physical activity program. Results. A total of 14 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03500393

A Remotely Supervised Exercise Program for Lung Cancer ... The purpose of this study is to conduct a pilot randomized controlled trial (RCT) evaluating the feasibility and potential effectiveness of a remotely ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7066706/

Physical Activity and Exercise in Lung Cancer Care Lung Cancer Exercise Training Study: A Randomized Trial of Aerobic Training, Resistance Training, or Both in Lung Cancer Patients, 160 LC, VO2peak. Sandy Jack.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016950022500039X

Mitigation of decline with virtual exercise with lung cancer ... A 12-week virtually supervised exercise program for patients with advanced lung cancer showed high attendance and adherence, with significant improvements in ...