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

January 9, 2024 updated by: NRG Oncology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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:

I. 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:

I. 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 Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Chambersburg, Pennsylvania, United States, 17201
        • Recruiting
        • WellSpan Health - Chambersburg
        • Principal Investigator:
          • Amit Shah, MD
        • Contact:
      • Ephrata, Pennsylvania, United States, 17522
        • Recruiting
        • WellSpan Health - Ephrata
        • Principal Investigator:
          • Amit Shah, MD
        • Contact:
      • Gettysburg, Pennsylvania, United States, 17325
        • Recruiting
        • WellSpan Health - Gettysburg
        • Principal Investigator:
          • Amit Shah, MD
        • Contact:
      • Lebanon, Pennsylvania, United States, 17042
        • Recruiting
        • WellSpan Health - Lebanon
        • Principal Investigator:
          • Amit Shah, MD
        • Contact:
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health - York
        • Principal Investigator:
          • Amit Shah, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm I: Usual Care
Patients will receive their usual care of thoracic radiotherapy with concurrent chemotherapy.
Experimental: Arm II: Usual Care + Continuous physical activity monitoring via a wearable device
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
Activity tracker that is worn on the wrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From study enrollment to 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.
From study enrollment to 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.
From study enrollment to radiotherapy completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

Pennsylvania Department of Health Commonwealth Universal Research Enhancement Program (PA CURE)

Investigators

  • Principal Investigator: Nitin Ohri, MD, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Estimated)

July 10, 2024

Study Completion (Estimated)

July 10, 2026

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRGF-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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