Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Conditions
Brief 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.
Detailed 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.
Interventions
OTHERExercise Counseling
Receive call from health coach
OTHERExercise Intervention
Undergo routine exercise
OTHERInternet-Based Intervention
Receive Android tablet
OTHERInterview
Complete a qualitative interview
OTHERMedical Device Usage and Evaluation
Wear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Baseline to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life fatigue assessement | Baseline to 3 months | 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. |
Countries
United States
Outcome results
None listed