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

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05407038
• Other study ID #: 21-013228
• Secondary ID: NCI-2022-0215521
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Lung Non-Small Cell Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Intervention

Other:
• Exercise Counseling
Receive call from health coach
• Exercise Intervention
Undergo routine exercise
• Internet-Based Intervention
Receive Android tablet
• Interview
Complete a qualitative interview
• Medical Device Usage and Evaluation
Wear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 3 months
Secondary	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.	Baseline to 3 months