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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-17

Study Completion Date

2023-12-26

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Exercise Counseling

Intervention Type OTHER

Receive call from health coach

Exercise Intervention

Intervention Type OTHER

Undergo routine exercise

Internet-Based Intervention

Intervention Type OTHER

Receive Android tablet

Interview

Intervention Type OTHER

Complete a qualitative interview

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Exercise Counseling

Receive call from health coach

Intervention Type OTHER

Exercise Intervention

Undergo routine exercise

Intervention Type OTHER

Internet-Based Intervention

Receive Android tablet

Intervention Type OTHER

Interview

Complete a qualitative interview

Intervention Type OTHER

Medical Device Usage and Evaluation

Wear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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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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