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

NCT05407038 | Terminated DMC

• 2 other identifiers: 21-013228NCI-2022-02155
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life fatigue assessement

  Baseline to 3 months

Study Arms (1)

Supportive care (remote monitoring with health coaching)

EXPERIMENTAL

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.

Other: Exercise Counseling; Other: Exercise Intervention; Other: Internet-Based Intervention; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

Interventions

Exercise Counseling OTHER

Receive call from health coach

Supportive care (remote monitoring with health coaching)

Exercise Intervention OTHER

Undergo routine exercise

Supportive care (remote monitoring with health coaching)

Internet-Based Intervention OTHER

Receive Android tablet

Supportive care (remote monitoring with health coaching)

Interview OTHER

Complete a qualitative interview

Supportive care (remote monitoring with health coaching)

Medical Device Usage and Evaluation OTHER

Wear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter

Supportive care (remote monitoring with health coaching)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (remote monitoring with health coaching)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Roberto P. Benzo, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 7, 2022
• Study Start: August 17, 2022
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

US (1)