Advanced Lung Non-Small Cell CarcinomaNCT05407038
Remote Monitoring With Health-Coaching for Lifestyle Changes in Patients With Lung Cancer Related Fatigue
A study testing Exercise Counseling, Exercise Intervention and Internet-Based Intervention in people with Advanced Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8
- What is being tested?
- Exercise Counseling, Exercise Intervention and Internet-Based Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 26 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- They have cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- 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
- Being tested
- Exercise Counseling, Exercise Intervention, Internet-Based Intervention, Interview, Medical Device Usage and Evaluation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise CounselingOther
Receive call from health coach
Undergo routine exercise
Internet-Based InterventionOther
Receive Android tablet
InterviewOther
Complete a qualitative interview
Medical Device Usage and EvaluationOther
Wear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise Counseling; Other: Exercise Intervention; Other: Internet-Based Intervention; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months
Secondary outcomes (1)
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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start17 Aug 2022
- Primary completion26 Dec 2023
- Study completion26 Dec 2023
Why it stopped: Study stopped early due to enrollment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto P. Benzo, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407038
- Sponsor's protocol ID
- 21-013228
- Other IDs
- NCI-2022-02155, 21-013228
- Status last verified
- Feb 2025
- First submitted
- 19 May 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring With Health-Coaching for Lifestyle Changes in Patients With Lung Cancer Related Fatigue
- ClinicalTrials.gov ID
- NCT05407038
- Acronym / sponsor ID
- 21-013228
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped early due to enrollment challenges.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (remote monitoring with health coaching) | Experimental | Other: Exercise Counseling, Other: Exercise Intervention, Other: Internet-Based Intervention, Other: Interview, Other: Medical Device Usage and Evaluation, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- They have cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise CounselingReceive call from health coach | Other | Supportive care (remote monitoring with health coaching) |
| Exercise InterventionUndergo routine exercise | Other | Supportive care (remote monitoring with health coaching) |
| Internet-Based InterventionReceive Android tablet | Other | Supportive care (remote monitoring with health coaching) |
| InterviewComplete a qualitative interview | Other | Supportive care (remote monitoring with health coaching) |
| Medical Device Usage and EvaluationWear Garmin Vivofit and Nonin 3150 WristOx2 pulse oximeter | Other | Supportive care (remote monitoring with health coaching) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (remote monitoring with health coaching) |
Primary outcome
Fatigue
Time frame: Baseline to 3 months
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.
1 secondary outcome
Quality of life fatigue assessement
Time frame: Baseline to 3 months
Results and safety
The study was stopped early (reason given: Study stopped early due to enrollment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto P. Benzo, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Counseling, Exercise Intervention and Internet-Based Intervention in people with Advanced Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study stopped early due to enrollment challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.