Remote Monitoring With Health-Coaching for Lifestyle Changes in Patients With Lung Cancer Related Fatigue
NCT ID: NCT05407038
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2022-08-17
2023-12-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (remote monitoring with health coaching)
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Roberto P. Benzo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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21-013228
Identifier Type: -
Identifier Source: org_study_id
NCI-2022-02155
Identifier Type: REGISTRY
Identifier Source: secondary_id
21-013228
Identifier Type: OTHER
Identifier Source: secondary_id
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