Testing the Addition of Activity Monitoring With a Wearable Electronic Device to Improve Patient Care During Treatment for Lung Cancer

NCT04878952 | Terminated DMC

• 1 other identifier: NRGF-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

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 improved supportive care and reduce the rate of adverse events during the course of radiation treatment.

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

Outcome Measures

Primary Outcomes (3)

• Occurrence of hospital admission

  Occurrence of hospital admission during radiation treatment or within 1 month after radiotherapy completion.

  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.

  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.

  From study enrollment to radiotherapy completion.

Study Arms (2)

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.

Other: Garmin Vivofit Activity Tracker

Interventions

Garmin Vivofit Activity Tracker OTHER

Activity tracker that is worn on the wrist.

Arm II: Usual Care + Continuous physical activity monitoring via a wearable device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NRG Oncology: lead
• Pennsylvania Department of Health Commonwealth Universal Research Enhancement Program (PA CURE): collaborator

Study Sites (5)

WellSpan Health - Chambersburg

Chambersburg, Pennsylvania, 17201, United States

Location

WellSpan Health - Ephrata

Ephrata, Pennsylvania, 17522, United States

Location

WellSpan Health - Gettysburg

Gettysburg, Pennsylvania, 17325, United States

Location

WellSpan Health - Lebanon

Lebanon, Pennsylvania, 17042, United States

Location

WellSpan Health - York

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nitin Ohri, MD

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 10, 2021
• Study Start: August 26, 2021
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Locations

US (5)