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

Mayo Clinic7 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Advanced Lung Non-Small Cell Carcinoma

Interventions

Exercise CounselingOTHER

Receive call from health coach

Exercise InterventionOTHER

Undergo routine exercise

Internet-Based InterventionOTHER

Receive Android tablet

InterviewOTHER

Complete a qualitative interview

Medical Device Usage and EvaluationOTHER

Wear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Fatigue

The BFI is a nine item questionnaire with a 10 point numeric scale measuring fatigue level and it's interference with daily life. The higher the score the more fatigue.

Time frame: Baseline to 3 months

Secondary Outcomes

Quality of life fatigue assessement

The functional assessment is a 50 item questionnaire that measures self-reported fatigue and its impact on daily living using a Likert scale from Not at all (0) to Very Much (4).The higher the score the more symptoms interfere with daily living.