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

Mayo Clinic

Status

Active, not recruiting

Conditions

Stage IIIB Lung Cancer AJCC v8

Stage IIIA Lung Cancer AJCC v8

Stage IVA Lung Cancer AJCC v8

Stage III Lung Cancer AJCC v8

Stage IVB Lung Cancer AJCC v8

Stage IIIC Lung Cancer AJCC v8

Advanced Lung Non-Small Cell Carcinoma

Stage IV Lung Cancer AJCC v8

Treatments

Other: Exercise Intervention

Other: Medical Device Usage and Evaluation

Other: Internet-Based Intervention

Other: Questionnaire Administration

Other: Exercise Counseling

Other: Interview

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05407038

21-013228 (Other Identifier)

NCI-2022-02155 (Registry Identifier)

Details and patient eligibility

About

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.

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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