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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-02155 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 21-013228 | Other Identifier | Mayo Clinic Institutional Review Board |
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Study stopped early due to enrollment challenges.
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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.
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 VÃvofit 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (remote monitoring with health coaching) | Experimental | Patients undergo routine exercise using a remote monitoring system (Garmin VÃvofit 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Counseling | Other | Receive call from health coach |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto P. Benzo, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Exercise Intervention | Other | Undergo routine exercise |
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| Internet-Based Intervention | Other | Receive Android tablet |
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| Interview | Other | Complete a qualitative interview |
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| Medical Device Usage and Evaluation | Other | Wear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter |
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| Questionnaire Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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