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NCT Number: NCT03340714

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

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.

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Key information

Conditions

Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monitoring Device

Device

Wear ADAMM

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Collaborators

  • Health Care Originals, Inc.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Nov 13, 2017
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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