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

7 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial investigates the effectiveness of a remote monitoring program for lifestyle changes in patients with lung cancer related fatigue (CRF). Fatigue is a common symptom of lung cancer and a side-effect of cancer treatments. CRF has a negative impact on patients' quality of life, daily activities, employment, social relationships and mood. Health coaches enable patients to develop and achieve self-determined wellness goals and assist patients to use their insight, personal strengths, goal setting, action steps, and accountability toward achieving healthy lifestyle changes. Remote monitoring with health-coaching may help relieve lung cancer related fatigue and increase the quality of life in cancer patients.

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+