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Remote Health Coaching for Lung Cancer
N/A
Waitlist Available
Led By Roberto P. Benzo, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months
Awards & highlights
Study Summary
This trial will test whether a remote monitoring program that provides health coaching can help relieve fatigue and improve quality of life for lung cancer patients.
Who is the study for?
This trial is for adults over 18 with advanced non-small cell lung cancer (NSCLC) who are undergoing treatment and experience moderate to severe fatigue. They must be able to communicate in English or Spanish, have a life expectancy of at least 6 months, and receive care at Mayo Clinic locations specified. Those with cognitive or psychiatric conditions that affect consent or participation cannot join.Check my eligibility
What is being tested?
The study tests a remote monitoring program combined with health coaching aimed at lifestyle changes to alleviate fatigue related to lung cancer. Patients will use medical devices, answer questionnaires, receive exercise counseling and intervention, participate in internet-based interventions, and undergo interviews.See study design
What are the potential side effects?
Since this trial focuses on lifestyle changes rather than medication, side effects may include discomfort from increased physical activity or stress from adapting new habits. The use of medical devices might cause minor skin irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My average fatigue over the last week is 4 or higher.
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I can perform daily activities with little to no assistance.
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I am receiving treatment for advanced non-small cell lung cancer that is not intended to cure.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fatigue
Secondary outcome measures
Quality of life fatigue assessement
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (remote monitoring with health coaching)Experimental Treatment6 Interventions
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,076 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,660 Total Patients Enrolled
Roberto P. Benzo, M.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My average fatigue over the last week is 4 or higher.I can perform daily activities with little to no assistance.I can read and answer questions in English or Spanish.I am receiving treatment for advanced non-small cell lung cancer that is not intended to cure.I am older than 18 years.You are expected to live for at least 6 more months.You are currently receiving main cancer treatment at Mayo Clinic, Rochester, or Mayo Clinic Health System.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (remote monitoring with health coaching)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have taken part in the experiment thus far?
"Affirmative. The details available on clinicaltrials.gov reveal that the trial, which was initially listed on August 17th 2022, is actively seeking participants. This study requires 30 people to be enrolled at just one medical site."
Answered by AI
Is there still an opportunity to join this clinical research project?
"This investigation, which was initially posted on August 17th 2022 and subsequently amended on October 7th 2022, is currently recruiting participants as indicated by clinicaltrials.gov."
Answered by AI
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