Status:
TERMINATED
Testing the Addition of Activity Monitoring With a Wearable Electronic Device to Improve Patient Care During Treatment for Lung Cancer
Lead Sponsor:
NRG Oncology
Collaborating Sponsors:
Pennsylvania Department of Health Commonwealth Universal Research Enhancement Program (PA CURE)
Conditions:
Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage III
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 improve...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04878952
Start Date
August 26 2021
End Date
August 12 2024
Last Update
September 4 2024
Active Locations (5)
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1
WellSpan Health - Chambersburg
Chambersburg, Pennsylvania, United States, 17201
2
WellSpan Health - Ephrata
Ephrata, Pennsylvania, United States, 17522
3
WellSpan Health - Gettysburg
Gettysburg, Pennsylvania, United States, 17325
4
WellSpan Health - Lebanon
Lebanon, Pennsylvania, United States, 17042