Non-small Cell Lung CancerNCT04878952
Testing the Addition of Activity Monitoring With a Wearable Electronic Device to Improve Patient Care During Treatment for Lung Cancer
A study testing Garmin Vivofit Activity Tracker in people with Non-small Cell Lung Cancer and Non-small Cell Lung Cancer Stage III, run by NRG Oncology at 5 sites in United States.
Trial summary
This trial will examine if the monitoring of daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse events during the course of radiation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage III, Recurrent Non Small Cell Lung Cancer
- What is being tested?
- Garmin Vivofit Activity Tracker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Aug 2021to 12 Aug 2024
- 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
- Pathologically (histologically or cytologically) proven diagnosis of NSCLC
- Planned initiation (within the 30 days after study registration) of fractionated (≥15 treatments) thoracic radiotherapy with concurrent chemotherapy. Expected treatment scenarios include:
- Definitive treatment of stage III disease (most common)
- Definitive treatment for locoregional recurrence of early stage disease
- Definitive treatment of unresectable stage II disease
- Preoperative treatment of stage III disease
Show all 13Show fewer
- Postoperative treatment after incomplete resection (uncommon)
- Radical treatment for a patient with advanced/metastatic disease with the goal of achieving long-term thoracic disease control (e.g., oligometastatic disease where metastases are addressed with resection or stereotactic radiotherapy)
- ECOG Performance Status 0-3 within 30 days prior to registration
- Age ≥ 18
- Ambulates independently or with a cane (use of a walker not permitted)
- Patients who already use wearable devices and/or smartphones that monitor physical activity are eligible for this trial. Patients must agree to wear the device provided by the study.
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
Who cannot join
- Patients with a history of another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy for NSCLC
- Patients receiving concurrent treatment for another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy
- Patients receiving thoracic radiotherapy without concurrent chemotherapy are ineligible. Patients receiving concurrent chemotherapy and another form of systemic therapy (e.g., immunotherapy) are eligible. Patients receiving radiotherapy with concurrent immunotherapy or targeted therapy but without chemotherapy are ineligible
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
WellSpan Health - Chambersburg
Chambersburg, Pennsylvania, 17201
WellSpan Health - Ephrata
Ephrata, Pennsylvania, 17522
WellSpan Health - Gettysburg
Gettysburg, Pennsylvania, 17325
WellSpan Health - Lebanon
Lebanon, Pennsylvania, 17042
WellSpan Health - York
York, Pennsylvania, 17403
About this study
Official title: Activity Monitoring to Improve Patient Care During Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer (LA-NSCLC)
This trial will examine if the monitoring of daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse events during the course of radiation treatment.
Read the detailed description
PRIMARY OBJECTIVE:
To demonstrate that monitoring daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse clinical events during the radiotherapy course.
SECONDARY OBJECTIVES:
- To demonstrate the feasibility of monitoring daily step counts during a course of chemoradiotherapy in the setting of a multi-institutional trial.
II. To examine the association between baseline activity level and clinical outcomes related to treatment tolerance, quality of life, chemoradiotherapy adverse events, and physical function preservation.
III. To demonstrate associations between daily step counts and short-term hospitalization risk.
IV. To explore predictors of step count decline during chemoradiotherapy among clinical factors and radiotherapy plan parameters.
EXPLORATORY OBJECTIVES:
- To explore patterns of care regarding adjuvant immunotherapy administration following definitive chemoradiotherapy for locally advanced non-small cell lung cancer.
II. To examine the association between baseline activity level with progression free survival and overall survival.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Usual Care
ARM II: Usual Care + Continuous physical activity monitoring via a wearable device.
Patients randomized to undergo activity monitoring will use a wearable device from the time of study enrollment until four weeks after the completion of thoracic radiotherapy.
- Conditions
- Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage III, Recurrent Non Small Cell Lung Cancer
- Being tested
- Garmin Vivofit Activity Tracker
- Keywords
- Locally advanced non-small cell lung cancer, LA-NSCLC, Activity Tracking
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garmin Vivofit Activity TrackerOther
Activity tracker that is worn on the wrist.
| Study group | Role | What they receive |
|---|---|---|
| Arm I: Usual Care | No intervention | Patients will receive their usual care of thoracic radiotherapy with concurrent chemotherapy. |
| Arm II: Usual Care + Continuous physical activity monitoring via a wearable device | Experimental | Patients will receive their usual care of thoracic radiotherapy with concurrent chemotherapy along with continuous physical activity monitoring via a wearable device. Receives: Other: Garmin Vivofit Activity Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of hospital admission
Occurrence of hospital admission during radiation treatment or within 1 month after radiotherapy completion.
Measured: From study enrollment to 1 month after radiotherapy completion.
Occurrence of emergency room visit lasting more than 24 hours
Occurrence of emergency room visit lasting more than 24 hours during radiation treatment or within 1 month after radiotherapy completion.
Measured: From study enrollment to 1 month after radiotherapy completion.
Occurrence of radiation treatment interruption
Occurrence of of radiation treatment interruption (missing two or more treatments, not due to machine issues or scheduled holidays) during radiation treatment.
Measured: From study enrollment to radiotherapy completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start26 Aug 2021
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Why it stopped: will not be able to meet study accrual objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by NRG OncologyThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health Commonwealth Universal Research Enhancement Program (PA CURE)
- Responsible party
- Sponsor
- Investigators
- Nitin Ohri, MD, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878952
- Sponsor's protocol ID
- NRGF-001
- Status last verified
- Aug 2024
- First submitted
- 30 Apr 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity Monitoring to Improve Patient Care During Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer (LA-NSCLC)
- ClinicalTrials.gov ID
- NCT04878952
- Acronym / sponsor ID
- NRGF-001
- Conditions
- Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage III, Recurrent Non Small Cell Lung Cancer
- Keywords
- Locally advanced non-small cell lung cancer, LA-NSCLC, Activity Tracking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: will not be able to meet study accrual objectives.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- NRG OncologyUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health Commonwealth Universal Research Enhancement Program (PA CURE)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 10 May 2021 (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 trial will examine if the monitoring of daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse events during the course of radiation treatment.
Detailed description
PRIMARY OBJECTIVE:
To demonstrate that monitoring daily step counts during a course of concurrent chemoradiotherapy for locally advanced non-small cell lung cancer will enable clinicians to deliver improved supportive care and reduce the rate of adverse clinical events during the radiotherapy course.
SECONDARY OBJECTIVES:
- To demonstrate the feasibility of monitoring daily step counts during a course of chemoradiotherapy in the setting of a multi-institutional trial.
II. To examine the association between baseline activity level and clinical outcomes related to treatment tolerance, quality of life, chemoradiotherapy adverse events, and physical function preservation.
III. To demonstrate associations between daily step counts and short-term hospitalization risk.
IV. To explore predictors of step count decline during chemoradiotherapy among clinical factors and radiotherapy plan parameters.
EXPLORATORY OBJECTIVES:
- To explore patterns of care regarding adjuvant immunotherapy administration following definitive chemoradiotherapy for locally advanced non-small cell lung cancer.
II. To examine the association between baseline activity level with progression free survival and overall survival.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Usual Care
ARM II: Usual Care + Continuous physical activity monitoring via a wearable device.
Patients randomized to undergo activity monitoring will use a wearable device from the time of study enrollment until four weeks after the completion of thoracic radiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: Usual Care | No intervention | –Patients will receive their usual care of thoracic radiotherapy with concurrent chemotherapy. |
| Arm II: Usual Care + Continuous physical activity monitoring via a wearable device | Experimental | Other: Garmin Vivofit Activity TrackerPatients will receive their usual care of thoracic radiotherapy with concurrent chemotherapy along with continuous physical activity monitoring via a wearable device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Pathologically (histologically or cytologically) proven diagnosis of NSCLC
- Planned initiation (within the 30 days after study registration) of fractionated (≥15 treatments) thoracic radiotherapy with concurrent chemotherapy. Expected treatment scenarios include:
- ECOG Performance Status 0-3 within 30 days prior to registration
- Age ≥ 18
- Ambulates independently or with a cane (use of a walker not permitted)
Key exclusion criteria (3 listed)
- Patients with a history of another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy for NSCLC
- Patients receiving concurrent treatment for another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy
- Patients receiving thoracic radiotherapy without concurrent chemotherapy are ineligible. Patients receiving concurrent chemotherapy and another form of systemic therapy (e.g., immunotherapy) are eligible. Patients receiving radiotherapy with concurrent immunotherapy or targeted therapy but without chemotherapy are ineligible
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 |
|---|---|---|
| Garmin Vivofit Activity TrackerActivity tracker that is worn on the wrist. | Other | Arm II: Usual Care + Continuous physical activity monitoring via a wearable device |
Primary outcome
Occurrence of hospital admission
Time frame: From study enrollment to 1 month after radiotherapy completion.
Occurrence of hospital admission during radiation treatment or within 1 month after radiotherapy completion.
Occurrence of emergency room visit lasting more than 24 hours
Time frame: From study enrollment to 1 month after radiotherapy completion.
Occurrence of emergency room visit lasting more than 24 hours during radiation treatment or within 1 month after radiotherapy completion.
Occurrence of radiation treatment interruption
Time frame: From study enrollment to radiotherapy completion.
Occurrence of of radiation treatment interruption (missing two or more treatments, not due to machine issues or scheduled holidays) during radiation treatment.
Results and safety
The study was stopped early (reason given: will not be able to meet study accrual objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Nitin Ohri, MD principal investigator
NRG Oncology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garmin Vivofit Activity Tracker in people with Non-small Cell Lung Cancer and Non-small Cell Lung Cancer Stage III, run by NRG Oncology at 5 sites 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 13 inclusion and 3 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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: will not be able to meet study accrual objectives.). 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?
Occurrence of hospital admission (time frame: From study enrollment to 1 month after radiotherapy completion.). The study lists 3 primary outcomes in all. 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 8 May 2026.