Lung Cancer Clinical Trial

Remote Monitoring With Health-Coaching for Lifestyle Changes in Patients With Lung Cancer Related Fatigue

Summary

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.

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Full Description

PRIMARY OBJECTIVE:

I. To assess the effect of the remote-monitoring program on patient reported fatigue by administering the Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy Fatigue (FACT-F), Functional Assessment of Cancer Therapy- Lung (FACT-L) and the Modified Fatigue Impact Scale (MFIS).

OUTLINE:

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.

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Eligibility Criteria

Inclusion Criteria:

Diagnosed with advanced lung non-small cell carcinoma (NSCLC) being treated with any line of non-curative intent, systemic treatment.
Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2.
The ability to read and respond to questions in English or Spanish
Receiving primary cancer care at Mayo Clinic, Rochester or Mayo Clinic Health System (MCHS).
Age > 18 years.
Life expectancy at least 6 months.
Moderate or higher fatigue (>= 4) on a scale of 0-10 based on fatigue rating to question: Rate your average fatigue over the last week, where 0 is no fatigue and 10 is extreme fatigue.

Exclusion Criteria:

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

Study is for people with:

Lung Cancer

Estimated Enrollment:

30

Study ID:

NCT05407038

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Clinical Trial Referral Office
Contact
855-776-0015
[email protected]
Roberto P. Benzo, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

30

Study ID:

NCT05407038

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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