Automated Device for Asthma Monitoring and Management in Monitoring Adults With Lung Cancer Undergoing Radiation Therapy

May 14, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

A Pilot Study Investigating the Feasibility of ADAMM (Automated Device for Asthma Monitoring and Management) in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Lung Cancer

This pilot early phase I trial studies the Automated Device for Asthma Monitoring and Management in monitoring adult patients with lung cancer who are undergoing radiation therapy. The Automated Device for Asthma Monitoring and Management may provide useful information to doctors to help monitor adult patients with lung cancer and diagnose certain conditions earlier than traditional means.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Determine compliance with the Automated Device for Asthma Monitoring and Management (ADAMM) device in patients receiving radiation therapy (RT) for lung cancer.

SECONDARY OBJECTIVES:

I. Evaluate feasibility of recruitment, acceptability of the ADAMM device, and compliance with electronic patient-reported outcomes (ePROs) in this patient population

Study Type

Observational

Enrollment (Actual)

24

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 Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Sidney Kimmel Cancer Center at Thomas Jefferson University

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

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic and non-metastatic lung cancer being treated with radiotherapy

Description

Inclusion Criteria:

  • Patients are capable of giving informed consent
  • Patients are eligible to be treated with RT and plan to start treatment
  • Patients have either metastatic or non-metastatic lung cancer as defined in history and physical
  • Patients must be able to read or speak English
  • Women of reproductive potential should have a negative serum or urine pregnancy test within one week prior to radiation planning CT scan

Exclusion Criteria:

  • Patients who cannot read or speak English
  • Patients who are not candidates for RT treatment
  • Women of childbearing potential who are pregnant or breastfeeding

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Device Feasibility (ADAMM)
Patients wear the Automated Device for Asthma Monitoring and Management (ADAMM) from the time of computed tomography (CT) simulation for radiation therapy (RT) planning throughout the entire RT course and for 4 weeks post-RT
Device: Monitoring Device
Wear ADAMM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device
Time Frame: Up to 4 weeks post-radiation therapy
The compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Up to 4 weeks post-radiation therapy
Percentage of days per study period that patients wear the Automated Device for Asthma Monitoring and Management device
Time Frame: Up to 4 weeks post-radiation therapy
The compliance rate along with a one-sided exact 95% confidence interval will be estimated.
Up to 4 weeks post-radiation therapy

Collaborators and Investigators

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

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Health Care Originals, Inc.

Investigators

  • Principal Investigator: Maria Werner-Wasik, MD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

March 20, 2018

Primary Completion (Actual)

October 25, 2021

Study Completion (Actual)

September 25, 2023

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17P.209
  • JT 10294 (Other Identifier: JeffTrial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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